All Available FDA-GCP Emails

Date
 
Title
06/12/2012 ---"Compassionate Use" Protocols
05/10/2002 ---"Conditional" Approval by IRB
10/25/2012 ---"GENERAL" Investigator Site ICF
06/15/2012 ---"Ideal" Resources for a Clinical Research Site
01/14/2005 ---"Lost to Follow Up" Guidance
02/24/2005 ---"mouse" signatures
02/09/2013 ---"Relevant" Communications (E6) vs. complete records (812.140)
02/16/2011 ---"Usual Care" Risks in Research Consent Forms
02/23/2003 ---(no subject)
11/19/2013 ---.gov Language on Consent Forms
03/19/2014 ---1 Continuing Review Question
08/06/2013 ---1 question
09/19/2011 ---1. Deviation - How to Call Properly, 2. NtF Proper Documentation
04/17/2009 ---2 Form FDA 1572s for 1 PI Doing Research at 2 Locations
06/25/2002 ---2 questions
07/09/2015 ---2 Questions
10/21/2013 ---2 questions for you
04/24/2012 ---2 Questions from [Redacted]
02/08/2012 ---2 Questions on Reporting Serious or Continuing Noncompliance to the FDA
06/16/2011 ---2 Research Questions
08/04/2010 ---3 General GCP Questions
02/22/2010 ---3 Questions
07/29/2013 ---3 Questions
12/15/2014 ---3rd Party Vendor Question
05/11/2004 ---5 GCP questions - Comments on question 8
05/04/2004 ---5 GCP questions - Response to Question #5
04/03/2013 ---5-lipoxygenase Inhibitor, MK-0633
11/05/2004 ---10 26 04 GCP Question regarding lab information on the Form FDA 1572
10/04/2006 ---12CFR Part 11, 11.100.c
10/30/2002 ---21 CFR 11
06/22/2005 ---21 CFR 11
12/12/2006 ---21 CFR 11
02/19/2010 ---21 CFR 11 and the IRB
11/10/2016 ---21 CFR 11 Electronic Signature Certification
05/07/2015 ---21 CFR 50, 56 vs 45 CFR 46
08/11/2015 ---21 CFR 50.25(c)
07/23/2008 ---21 CFR 54 Prior to 2299
05/28/2009 ---21 CFR 56 Docket FDA-2004-N-0117 Final Rule
09/30/2015 ---21 CFR 56.103 Question
06/03/2008 ---21 CFR 56.107 56.115 and Part 11 Questions
02/21/2013 ---21 CFR 56.108(b) Decision Tree
08/18/2015 ---21 CFR 56.109(c)
03/16/2011 ---21 CFR 312.23(a)(6)(iii)(b) Compliance Question
01/06/2005 ---21 CFR 312.50 Responsibility of Sponsor
02/25/2013 ---21 CFR 312.52 Question
10/02/2011 ---21 CFR 312.52-CRO
04/05/2005 ---21 CFR 312.62
11/19/2009 ---21 CFR 312.62 and 45 CFR 164.530 (j) (1) (2)
01/13/2010 ---21 CFR 812 Question
09/30/2008 ---21 CFR 812.150 (b)5
05/21/2004 ---21 CFR Part 11
07/02/2009 ---21 CFR Part 11
04/19/2005 ---21 CFR Part 11 (electronic records)
05/13/2011 ---21 CFR Part 11 Compliance
08/05/2016 ---21 CFR Part 11 Compliance
02/13/2012 ---21 CFR Part 11 Compliance and Study Financial Tracking and Management Systems
03/24/2010 ---21 CFR Part 11 Compliance Inquiry
07/07/2006 ---21 CFR Part 11 Regarding Clinical Data Management System
07/15/2012 ---21 CFR Part 11 Requirements - Apply to non-US sites under a US IND?
07/23/2011 ---21 CFR Part 50 for In Vitro Diagnostics
04/27/2004 ---21 CFR Question
05/24/2004 ---21 CFR question
06/19/2007 ---21 CFR vs 45 CFR
04/14/2008 ---21 CRF Part 11
03/27/2012 ---21 CRF Part 11
07/20/2015 ---21 Part 11 Audits
05/10/2002 ---21 Parts 50, 56 and 312 "Good Clinical Practices"
05/20/2002 ---21CFR11 Validation
05/21/2014 ---28 Day Mortality
10/14/2004 ---30 Day Period Between Studies
12/29/2010 ---30 Day Waiting Period between Clinical Trials
05/12/2008 ---45 CFR 46.116
10/24/2011 ---50.23 And Studies with Armed Forces
11/12/2009 ---50.24 Draft Guidance
02/23/2010 ---50.24 guidance
01/17/2013 ---50.25 (c) and the Short Form
02/19/2013 ---50.25 c - ClinicalTrials.gov Language
12/09/2015 ---50.25 C language Revisions
10/15/2013 ---50.25 C Pediatric Study
12/02/2013 ---50.25 C Question Addendum or Screening Consents
10/28/2009 ---56-110(c) - Expedited Review
03/12/2013 ---312.120 guidance question
12/03/2010 ---483 Form
01/05/2010 ---483 Location
07/16/2002 ---483 Release
05/09/2008 ---483 Response Time
04/08/2009 ---483s Issued to Foreign Clinical Investigators
09/01/2010 ---483s Public or Private
09/13/2004 ---505(i) and 520(g)
09/05/2014 ---510(k) Approved Products - Need for clinicaltrials.gov Statement in Consent Form
08/17/2011 ---639 Question regarding Investigator Delegation
08/30/2011 ---748 1571 Questions
09/15/2011 ---925 Question about the Financial Disclosure
09/30/2004 ---1488 Referral
09/30/2004 ---1488 Referral by [Redacted]
06/21/2012 ---1571 - 1572 Question
11/11/2010 ---1571 and CRO question
08/29/2012 ---1571 and Transfer of Obligations
09/06/2012 ---1571 and Transfer of Obligations
06/28/2011 ---1571 Inquiry
12/14/2009 ---1571-Block11-Question1
07/30/2002 ---1572
03/20/2003 ---1572
06/13/2003 ---1572
07/24/2003 ---1572
11/24/2003 ---1572
05/04/2004 ---1572
08/16/2004 ---1572
10/07/2004 ---1572
11/09/2005 ---1572
01/30/2006 ---1572
08/16/2006 ---1572
11/07/2006 ---1572
12/13/2006 ---1572
12/13/2007 ---1572
07/02/2009 ---1572
09/11/2009 ---1572
03/01/2010 ---1572
04/29/2010 ---1572
06/21/2010 ---1572
07/23/2010 ---1572
04/04/2012 ---1572
05/31/2012 ---1572
09/27/2012 ---1572
10/16/2014 ---1572
10/01/2004 ---1572 - Box 6
06/12/2013 ---1572 - Boxes Left Blank
02/07/2012 ---1572 - Certified Language Translators/Interpreters
05/04/2004 ---1572 -Global
06/23/2010 ---1572 - Research Labs
06/23/2010 ---1572 - Research Labs
11/26/2012 ---1572 - Section 4 - Lab Certification Question
10/15/2004 ---1572 - Section one
10/20/2004 ---1572 - Section One
07/26/2012 ---1572 2/12
08/24/2010 ---1572 and/or IOR
10/15/2009 ---1572 and 2 Principal Investigators
12/02/2010 ---1572 and an Investigator Original Signature
04/11/2008 ---1572 and Box 4pmbb041108
03/05/2008 ---1572 and Box 5
05/05/2014 ---1572 and Coordinators Who only Consent Subjects
10/10/2008 ---1572 and Financial Disclosure Forms Investigator Signatures and Dates
07/11/2005 ---1572 and Informed Consent
01/12/2011 ---1572 at a Phase I Facility
09/06/2007 ---1572 Block 3
12/02/2011 ---1572 Box #6
09/24/2014 ---1572 Box 3 and Suite #s
11/12/2014 ---1572 Box 3 Question
08/11/2015 ---1572 box 4: Single Use Lab
07/29/2009 ---1572 Box 6 Who to Include
07/20/2012 ---1572 Change in PI
07/14/2010 ---1572 clarification
06/05/2012 ---1572 Clarification
09/19/2013 ---1572 Clarity
11/17/2008 ---1572 Commitment
12/26/2006 ---1572 Completion
09/20/2011 ---1572 Completion
12/10/2014 ---1572 Completion and Signature Requirements
09/02/2003 ---1572 completion question
07/14/2008 ---1572 Database
07/25/2012 ---1572 Expiration Date
01/29/2009 ---1572 Expiration Dates
01/06/2006 ---1572 Expiration Question
01/06/2006 ---1572 Expires
11/15/2007 ---1572 for Companion Study
10/05/2007 ---1572 for Expanded Access Protocol
05/09/2002 ---1572 Form
12/29/2005 ---1572 form
08/27/2009 ---1572 Form
09/23/2010 ---1572 Form
09/23/2010 ---1572 Form
11/21/2011 ---1572 Form
10/12/2012 ---1572 Form
09/13/2016 ---1572 Form
05/13/2013 ---1572 Form (Expiration Date April 30, 2015)
04/15/2010 ---1572 Form-Local lab
08/04/2010 ---1572 Form-Question
10/22/2013 ---1572 Form - Section 4
06/19/2010 ---1572 form: Urgent
04/28/2015 ---1572 Form and ePRO -eCOA Providers
12/05/2002 ---1572 Form and Info Sheets
07/20/2016 ---1572 Form Completion
07/20/2016 ---1572 Form Completion
08/14/2009 ---1572 Form Expiration Date
05/31/2009 ---1572 Form Expiration Date is May 31, 2009 New Form
05/28/2009 ---1572 Form Expired
06/18/2015 ---1572 Form expired
12/19/2016 ---1572 Form for Device Study
04/25/2014 ---1572 Form for Non US Study Team
07/19/2011 ---1572 Form Question
07/13/2016 ---1572 Form Question from [Redacted]
05/05/2011 ---1572 Forms
03/27/2013 ---1572 Forms
03/27/2013 ---1572 Forms
04/17/2008 ---1572 Forms for Non-US Studies
10/28/2010 ---1572 for Post Marketing Studies
05/26/2010 ---1572 Guidance - When to update 1572
08/24/2010 ---1572 Guidelines
08/12/2014 ---1572 Inclusion Questions
07/16/2007 ---1572 Inclusions
01/17/2012 ---1572 Inquiry
07/28/2007 ---1572 IRB Listing
02/24/2009 ---1572 Item #7 Question
08/30/2013 ---1572 Lab Entry
05/16/2011 ---1572 Lab Question
08/22/2007 ---1572 Line 4 Question
07/30/2010 ---1572 New
09/11/2012 ---1572 observational
04/25/2013 ---1572 OMB Expiration
06/19/2007 ---1572 Per Investigator
07/16/2010 ---1572 Phase I/II
02/18/2010 ---1572 Query on Laboratory Facilities
05/17/2002 ---1572 Question
04/22/2004 ---1572 Question
05/11/2004 ---1572 Question
09/22/2004 ---1572 question
01/14/2005 ---1572 Question
06/28/2005 ---1572 Question
10/24/2005 ---1572 question
10/25/2005 ---1572 Question
07/14/2006 ---1572 Question
01/19/2010 ---1572 Question
05/24/2010 ---1572 question
10/29/2010 ---1572 Question
12/11/2012 ---1572 Question
12/13/2012 ---1572 Question
05/29/2013 ---1572 Question
06/27/2013 ---1572 Question
10/15/2013 ---1572 Question
11/12/2013 ---1572 Question
07/28/2014 ---1572 Question
12/05/2014 ---1572 Question
12/19/2014 ---1572 Question
10/27/2015 ---1572 Question
08/23/2016 ---1572 Question
05/09/2006 ---1572 Question (2)
01/07/2013 ---1572 Question-Delay in Signing
04/16/2012 ---1572 Question - Sub-Study
08/04/2004 ---1572 question for FDA
08/04/2004 ---1572 question for FDA
04/08/2011 ---1572 Question in regards to Record Retention
01/14/2015 ---1572 Question regarding NON-US Investigators
09/05/2003 ---1572 questions
02/01/2008 ---1572 Questions
01/05/2011 ---1572 questions
07/06/2006 ---1572 Questions/Clarification
11/24/2009 ---1572 Question Third Page
07/07/2015 ---1572 Release Date Question
09/05/2006 ---1572 Required
01/13/2010 ---1572 Requirement
10/24/2003 ---1572 requirements
01/22/2014 ---1572 Requirements and Guidelines
02/18/2010 ---1572 Revision
07/15/2009 ---1572 Section 4 Lab Question
09/05/2014 ---1572 Section 4 Study Site Locations that Perform only CLIA Waived Tests
11/03/2005 ---1572 section 5
01/06/2015 ---1572 Section 6
12/07/2007 ---1572 Signatures and Non-US Sites
08/05/2004 ---1572 SMO Question
02/21/2011 ---1572 Staff on Rotation
07/21/2010 ---1572 Sub-Investigator
07/25/2008 ---1572 Sub-Investigators and Multiple PI Listing
05/13/2010 ---1572 Submission
02/23/2015 ---1572 Submission to IRB
02/09/2012 ---1572 Update
03/08/2006 ---1572 updated address
01/29/2015 ---1572 Update Question
11/02/2007 ---1572 Updates
02/16/2007 ---1572 Use Outside of USA
05/19/2009 ---1572 Version Expires 5-31-09
09/03/2015 ---1572 Versions
09/19/2013 ---1572, CV and Delegation Log
05/08/2009 ---1572- CI Legal Name Facility Address
03/12/2007 ---1572- Multiple IRBs
09/14/2007 ---1572- Satellite Sites
05/25/2007 ---1572- Who to Include
12/03/2015 ---1572/Home Health Question
04/12/2010 ---1572s
08/20/2015 ---1572s and Foreign Sites
01/26/2012 ---1572s and Investigators
10/07/2010 ---1572s for Cooperative Group Studies
10/07/2010 ---1572s for Cooperative Group Studies
10/07/2010 ---1572s for Cooperative Group Studies
03/11/2005 ---1572S For Foreign Sites
11/08/2006 ---1995 FDA/NIH Report on the Public Forum on Informed Consent for Emergency Research
10/22/2008 ---2008 Version of GCP Guidelines
02/29/2012 ---2011 Inspection Data
02/28/2013 ---2012 Inspection Data
01/21/2014 ---2013 Inspection Data
02/03/2015 ---2013 Inspection Data
03/13/2008 ---3500A for Clinical Trial Not Requiring an IND-2
08/25/2006 ---3545 3544
05/30/2007 ---5024 Guidance
12/12/2008 ---5024 rule-FamilyMember-LAR
06/10/2015 ---? re 1572-Is a New Version being Generated
07/07/2011 ---About CIIL
08/21/2013 ---About Clinical Study Image (Source Data)
07/25/2013 ---About FDA Phrase required on ICFs
07/25/2013 ---About FDA Phrase required on ICFs
07/07/2011 ---About GCP Inspection Fee
02/01/2012 ---About GCP Inspection Question
02/01/2012 ---About GCP Inspection Question
02/08/2011 ---About GCP Training
02/14/2008 ---About Guidelines for Clinical Trials with Anti-Infective Agents
07/22/2014 ---About ICF Printing on 2 Sides of Page
12/18/2013 ---About Medical Devices
08/28/2016 ---About Section 801 of the FDA Act (FDAAA 801) - Clinical Trials
03/13/2011 ---About Single-Sided Copy ICF
04/17/2002 ---About statistical software accepted by FDA
04/26/2010 ---About the investigational Medicinal Product
04/26/2010 ---About the Investigational Medicinal Product
01/08/2014 ---About the Reference Drug for Clinical Trials in order to get FDA Approval
10/13/2010 ---Abstinence as Way of Contraception in Clinical Trials
05/20/2008 ---Academia and Compliance Question #2
06/07/2006 ---Acceptance of Clinical Trial Data from [Redacted]
04/01/2003 ---Acceptance of foreign data
06/29/2015 ---Access Revoke to Clinical Database
04/24/2009 ---Access to Clinical Trial Results
12/19/2008 ---Access to Electronic Medical Charts
12/30/2008 ---Access to Electronic Medical Charts
02/06/2006 ---Access to Electronic Medical Records
10/23/2013 ---Access to Non-Research Related Medical Records
10/14/2008 ---Access to Open Clinical Trials
01/17/2012 ---Access to Other Company Trial Specific Worksheet/Medical Record (completed/closed trial)
08/12/2009 ---Access to Records by Sponsor
05/24/2006 ---Access to Research Charts
03/06/2009 ---Access to Subject Records
01/16/2012 ---Access to the Private Practice Records of a Principal Investigator
08/01/2006 ---Accreditation of GCP Courses
02/15/2007 ---Accreditation Requirement for Clinical Trial Sample Analysis
06/10/2009 ---Accrual Hold during Amendments Review
01/08/2015 ---ACRP
11/07/2014 ---Actions against Investigators
09/03/2011 ---Actual Meaning of a Verse Used In 21CFR56.106 -
01/07/2012 ---Actual Meaning of a Word Used in 21CFR56.106
02/22/2006 ---Adaptive Trial Design
08/01/2008 ---Adding Dietician to FDA 1572
11/28/2012 ---Adding Identifiers to Informed Consent Documents
06/20/2008 ---Adding Lab on 1572
09/12/2015 ---Adding Patient Identifying Information to Consent
01/07/2004 ---Adding Physicians to FDA 1572
02/15/2011 ---Adding Study Coordinator as Subinvestigator on FDA Form 1572
06/20/2008 ---Adding Subject Number to ICD
06/25/2007 ---Adding Subject Number to ICF
08/08/2012 ---Additional Analysis after Study Completion
08/05/2015 ---Additional I/E Requirements - Not Specified by Protocol
02/02/2015 ---Additional IRB Responsibilities when FDA Observes Study Procedures
04/28/2011 ---Additional Record Retention Question
12/03/2010 ---Address Change of Sponsor
12/19/2006 ---Address for Acting Director of FDA Good Clinical Practice
01/18/2010 ---Address for AE Reporting
04/28/2014 ---Address for ORO?
07/27/2010 ---Address on the Medical License of PI Conducting Clinical Research at that Site
06/09/2003 ---Adequate Personnel
09/11/2009 ---Adherence of the Independent Ethics Committees outside the USA to 21CFR56
12/24/2015 ---Ad Hoc Narration of Procedure Demo Video by Research Staff
11/14/2011 ---Administration of Study Agent to Participant While Hospitalized at a Non-Study Site
06/01/2009 ---Administrative Changes to the Protocol
12/19/2011 ---Administrative Letter
08/18/2011 ---Adverse Drug Reaction Reporting
01/28/2015 ---Adverse Drug Reaction Reporting to IRB for Post-Approval KAB Study
07/07/2011 ---Adverse Event
05/25/2014 ---Adverse Event Definition
10/25/2006 ---Adverse Event Follow Up
11/05/2015 ---Adverse Event Leading to Subject Drop Out During Investigation
06/18/2012 ---Adverse Event Question
09/24/2013 ---Adverse Event Question
01/28/2010 ---Adverse Event Record Keeping
06/30/2004 ---Adverse event reporting
02/21/2006 ---Adverse Event Reporting
08/01/2008 ---Adverse Event Reporting
08/27/2008 ---Adverse Event Reporting
09/18/2014 ---Adverse Event Reporting
10/17/2013 ---Adverse Event Reporting: Intermittent Events
07/02/2009 ---Adverse Event Reporting and Monitoring
05/17/2011 ---Adverse Event Reporting Inquiry
08/28/2012 ---Adverse Event Reporting Procedure for Marketed Drugs being used in IDE and non-IDE Device Trials
03/12/2009 ---Adverse Event Reporting Question
05/05/2009 ---Adverse Event Reporting to IRBs
02/09/2005 ---Adverse Event Reports
09/12/2014 ---Adverse Event Review
01/29/2004 ---Adverse Events
04/15/2010 ---Adverse Events
06/25/2013 ---Adverse Events
04/20/2010 ---Adverse Events Collection for Screening Failures
08/11/2003 ---Adverse Events Reporting & Financial Interests of Clinical Investigators
07/09/2004 ---Adverse Events vs. Medical History
04/07/2004 ---Advertisements
01/28/2003 ---Advertisement vs. information
10/20/2003 ---Advertising
10/04/2010 ---Advertising Flyers
01/23/2003 ---Advertising for Clinical Trials
09/23/2011 ---Advertising for Clinical Trials
07/23/2002 ---advertising guidelines
02/28/2008 ---Advertising Marketing Unapproved Products
06/02/2003 ---Advertising question
04/17/2012 ---Advertising Question
10/06/2011 ---Advertising Remarks
08/10/2007 ---Advertising Requiring IRB Approval
09/26/2002 ---Advice
03/20/2008 ---Advice for Handling HIV
02/06/2008 ---Advice for Investigators
02/28/2003 ---Advice needed
09/19/2014 ---Advice on Sponsor Transfer of Responsibilities to a Phase I Unit
12/12/2007 ---Advice Service Query (Ref No. 38)
06/13/2008 ---Advisory Committees
02/22/2005 ---AE After Screening
01/12/2013 ---AE and SAE Collection
09/27/2006 ---AE and SAE reporting
03/29/2012 ---AE Assessment
09/30/2004 ---AE criteria for study related
07/07/2015 ---AE Data Collection When Should Both AESEV Severity Intensity and AETOXGR Standard Toxicity Grade be Collected
11/07/2007 ---AE Grading Scales
05/15/2002 ---AE Question
06/10/2005 ---AE Question
08/17/2004 ---AE Reporting
09/28/2011 ---AE reporting
10/29/2009 ---AE Reporting for a Device Trial
12/14/2007 ---AE Reporting for Discontinued Patient
02/04/2013 ---AE reporting in Device trial
05/15/2007 ---AE Reporting Post Market Studies
11/08/2002 ---AE Reporting Question
04/30/2003 ---AE Reporting Question
01/21/2011 ---AE reporting question
03/08/2010 ---AE Reporting Question - Changes in Severity
05/13/2009 ---AE Reporting to IRB's
11/11/2002 ---AE Reporting Under IND
05/08/2009 ---AE Reports- Does Indication Matter
05/04/2009 ---AE Reports for Studies with Different Route of Admin
06/26/2006 ---AE Reports Prior to IRB Approval
09/09/2002 ---AE requiring medical intervention-Medwatch form use
08/28/2006 ---AERs Database
12/04/2013 ---AEs and Amended Protocols
07/03/2007 ---AEs Before Randomization
08/15/2007 ---AEs Post-Marketing
02/13/2009 ---AEs Pregnancy Overdose
10/14/2005 ---AEs Seen With the Control
02/09/2010 ---After Completion or Termination of the Trial
02/09/2010 ---After Completion or Termination of the Trial
05/04/2010 ---After Completion or Termination of the Trial
04/06/2015 ---After Consent Withdrawal
08/13/2010 ---After IRB Withdrawal of Approval
04/07/2005 ---AIP Question
11/01/2006 ---Alarmed access
01/03/2006 ---ALCOA
08/01/2013 ---Alloderm
08/19/2013 ---Allowing Someone on LEIE list to Perform Clinical Research Duties
04/10/2013 ---ALS
05/24/2007 ---Altering Informed Consent Forms
06/15/2009 ---Alternate Members
05/08/2009 ---Amended Protocol or New Protocol
07/27/2011 ---Amendment Approval as Annual Renewal
05/04/2011 ---Amendment Protocols for Clinical Research
06/29/2015 ---Amendments to INDs
06/13/2007 ---Amendment to Protocol
03/30/2010 ---Amendment to Question re: Delegation of Authority for Clinical Study Physical Exams, ECG interpretations and Lab work interpretations
09/16/2010 ---Ancillary Supplies Return Policy
02/13/2013 ---ANDA - Investigational Product (IP) Retention
03/06/2006 ---ANDA submission guidance
02/27/2003 ---And more
02/27/2003 ---And more
05/03/2010 ---Animal Data in Informed Consent Forms
09/28/2007 ---Annual IRB Renewals
08/08/2014 ---Annual IRB Review Timeline Requirements for International Sites
04/27/2012 ---Annual Report of GCP Clinical Investigator Inspections
10/07/2011 ---Annual Reports according to CFR 312.33 - Filing at the Study Sites Necessary?
09/22/2008 ---Annual Review of FDA Regulated Research
04/24/2007 ---Annual Update 1572
01/31/2014 ---Anonymized GCP Inspection Reports/Findings
04/20/2004 ---Another Possible Source
06/14/2004 ---Another Question
01/21/2010 ---Another Question
06/25/2012 ---Another Question
07/02/2012 ---Another question
11/18/2013 ---Another Question for You
10/29/2004 ---Another quick question
05/24/2010 ---Another Set of Questions
02/12/2013 ---Antimigraine Guidance for Clinical Trial Design
06/10/2016 ---Any Grace Period for Submitting IND Annual Report to FDA
02/21/2008 ---Any Prohibitions
04/05/2006 ---Appeals IRB
12/30/2015 ---Applicability of 21 CFR 50 & 56
03/05/2008 ---Applicability of 21 CFR 56.109(c)(1)
12/16/2014 ---Applicability of 45 CFR 46
08/30/2007 ---Applicability of 312.6(a) for IND Studies Not Being Conducted in U.S. and Drug is Not Being Imported/Exported in U.S.
12/01/2011 ---Applicability of FDA Regulations to Nutritional Science Research
06/20/2015 ---Applicability of FDA Regulation to and ICH GCP to Public Health Intervention Studies
01/24/2012 ---Applicability of GCP to Observational (Non-Interventional) Studies
02/28/2003 ---Applicability of HIPAA Regulations to Manufacturers of Medical Products
05/20/2010 ---Applicability of Part 54
06/07/2010 ---Applicability of Part 54
11/06/2009 ---Applicability of Trial-Related Documents to GCP
11/17/2009 ---Applicability of Trial-Related Documents to GCP
09/20/2012 ---Applicable Clinical Trial - Registration on ClinicalTrials Website
10/21/2008 ---Applicable Regulations
12/30/2013 ---Application of Part 11 to EHR
01/28/2003 ---Application of questionnaires in clinical trials
04/12/2006 ---Applications Supported by Foreign Research
02/04/2010 ---Appropriate Delegation of Clinical Trial Tasks
02/04/2010 ---Appropriate Delegation of Clinical Trial Tasks
02/04/2010 ---Appropriate Delegation of Clinical Trial Tasks
10/24/2005 ---Appropriateness to Authorize work under draft SOP
02/28/2011 ---Approval of an amended Protocol
02/25/2008 ---Approval of Group Advertisement
08/15/2007 ---Approval of Surgical Procedures
02/12/2008 ---Approved Drug Use by Sponsor-Investigator
11/20/2012 ---Archival of Clinical Trial Documents
01/01/2010 ---Archival of Soft Copy Data
01/01/2010 ---Archival of Soft Copy Data
01/20/2011 ---Archived Clinical Trial
03/04/2014 ---Archived Study records
05/05/2004 ---Archived tissue samples and informed consent
09/15/2010 ---Archive of Safety Mailings at Site
07/23/2007 ---Archive of Study Records
05/19/2009 ---Archiving Clinical Research Trial Data
05/11/2004 ---Archiving essential documents for an observational study
01/20/2010 ---ArchivingICForms-ERecords
04/21/2010 ---Archiving Pharmaceutical Study Information
09/22/2008 ---Archiving Records
07/22/2009 ---Archiving Requirements
08/24/2011 ---Are One-page CVs Being Required
03/01/2006 ---Are prisoners vulnerable subjects
07/14/2009 ---Are Requests for Vaccine Trials Same as Drug Trials
10/10/2011 ---Are Site-Specific Procedures Auditable by The FDA?
06/04/2010 ---Are US Agents required for Foreign INDs?
09/22/2008 ---Arranging Inspections- Both Domestic and Foreign
07/01/2003 ---Artificial Cervical Disk.....?
11/26/2008 ---Ask for Help
01/28/2008 ---Asking Subjects to Discontinue Medication
11/03/2011 ---Assent Requirements for Subjects 18 Years and Over
03/27/2013 ---Assessment of Adverse Event Causality
06/11/2010 ---Assessment of Labs for a Clinical Trial
04/20/2012 ---Assigning Sub-Investigators to a Study
08/26/2011 ---Assistance Needed
03/16/2004 ---ASSISTANCE PLEASE
09/28/2010 ---Assistance Please
03/21/2013 ---Assistance Please
06/16/2011 ---Attaining a Certificate in Good Clinical Practice and Ethics
07/30/2015 ---Attempts to Collect Information from Discontinued Subjects
09/10/2003 ---Attention: Ms Carolyn Hommel - 1572 completion question
07/29/2003 ---Attention: Stan Woollen - HIPAA/Telephone Screening
03/26/2013 ---Audit
11/08/2010 ---Audit/Inspection of Financial Details
04/14/2014 ---Audit in BA/BE Studies
08/07/2013 ---Auditing
02/15/2008 ---Auditing Electronic CRF
05/09/2008 ---Auditing Electronic Databases
06/22/2016 ---Auditing Source from External Sites
05/02/2013 ---Auditor Contact Information
07/01/2004 ---Audit Question
12/16/2009 ---Audits by the Clinical Study Monitor
04/08/2011 ---Audit Trail Attributability
03/24/2016 ---Audit Trails
07/11/2002 ---Authorization to admin study meds
08/01/2011 ---Authorization use File Good Clinical Practice
01/16/2004 ---Authorized Site Signature Logs for Clinical Trials
05/16/2008 ---Automatically Populated Database Fields
10/16/2002 ---autonomy guidelines
08/15/2006 ---Availability of 1572s
08/18/2006 ---Availability of 1572s
10/21/2008 ---Availability of Final Guidance on AE Reporting for IRBs and Investigators
11/09/2009 ---Availability of HRML Version- 1572
01/15/2010 ---Availability of the Notification by Sponsor to Regulatory Authorities and IRB/IEC of CIOMS / MedWatch Reports
08/04/2008 ---Available GCP Training
06/08/2011 ---Available GCP Training
08/20/2016 ---BA/BE Study need FDA 1572
10/23/2015 ---Background Therapy and SOC
01/30/2007 ---Backup Tapes
12/19/2007 ---Bacteriophage Clinical Trials
04/15/2014 ---Bariatric Pacemaker
05/05/2010 ---Basic GCP Process Info
10/16/2009 ---Basic GCP Training
11/02/2004 ---Becoming Certified in Regulatory Affairs/clinical Trail Practice
09/06/2010 ---BE Facilities
02/06/2008 ---Behavior Testing Guideline and Standard for New Drug Development
12/03/2009 ---Belize
07/05/2007 ---Belmont Report
09/11/2003 ---Benchmarking information for Research Funds Flow
02/05/2009 ---The Benefits Section of IC
10/31/2007 ---Benefits to Study Subjects
07/13/2015 ---Best Practice for De-Identifying Data
08/15/2007 ---BF Edits Sponsor CPGM
05/07/2002 ---Bias
02/04/2009 ---Bias to the Subjects
04/10/2007 ---Billing- Study Costs
10/28/2008 ---Billing Insurance Companies
01/14/2015 ---BIMO
11/05/2007 ---A BIMO/GCP question
04/19/2016 ---BIMO Audit: Contents of Regulatory Files - CTA & CDA?
02/04/2016 ---BIMO Clinical Investigator Inspection Metrics for 483s
11/05/2007 ---A BIMOGCP Question
11/05/2007 ---A BIMOGCP Question CRO-Sponsor Agreement
03/24/2011 ---Bioanalytical
08/11/2009 ---Bioequivalence
07/24/2003 ---Bioethics
07/06/2012 ---Biological Sample Handling in Informed Consent
05/07/2013 ---Biomarker GCP
05/18/2015 ---Biometrics for Start-Up Question
05/18/2015 ---Biometrics for Start-Up Question
01/05/2009 ---Bioresearch Monitoring Information System Publication Schedule
03/11/2005 ---Bioresearch Monitoring Program
01/26/2016 ---Biosample Analysis from Screening Failures
06/15/2011 ---Biospecimen Storage Collection
04/19/2010 ---Blacklist
11/08/2006 ---Blank CRFs
03/09/2010 ---Blanket Approval
01/16/2013 ---BLA Submission Timeline
07/11/2013 ---Blinded Data Analysis
04/01/2008 ---Blinded Research Clinical Trials
09/26/2012 ---Blinded Study Information
09/08/2008 ---Block1-Acronyms-Inkstamps-Signatures
02/19/2008 ---Block 3
01/22/2009 ---Block 4-1572 Question
07/24/2007 ---Block 4- Analytical Labs
02/13/2009 ---Block4-GCP Compliance Question
05/29/2007 ---Block 6
09/02/2008 ---Block 6
10/29/2007 ---Block 6 Inquiry
02/12/2010 ---Block 6 of 1572
11/13/2009 ---Block 6- 1572
01/26/2009 ---Block7-FDA 1572 form
02/04/2010 ---Block8-1572 - Not found In FAQs of the Guidance Document
08/26/2008 ---Block 8- Outline of Study
12/14/2009 ---Block 11
04/05/2007 ---Block 14-15 1571
04/29/2008 ---Block Voting by IRBs During Continuing Review
05/26/2009 ---Blood Donation by Clinical Trial Participant
09/01/2016 ---Blood Draws
07/22/2004 ---Blood Draws from Research Subjects
07/22/2004 ---Blood Draws from Research Subjects
02/12/2008 ---Blood Samples and HIPAA
03/24/2009 ---Blood Volumes- Clinical Trials
01/20/2016 ---BMI Calculation Question
03/07/2003 ---Board Certification
05/13/2005 ---Board composition question
05/13/2005 ---Board composition question
09/18/2007 ---Board Members
02/02/2007 ---Bonuses
09/14/2006 ---Bonuses for Nurses
04/22/2002 ---Book of Guidelines
07/23/2014 ---Books and Reference Materials
06/12/2015 ---Botox Regulations
07/30/2011 ---Botox Trials
05/14/2003 ---Bottom line GCP requirements for database and data processing
08/10/2012 ---Box #4 of FDA Form 1572
11/13/2007 ---Box 1 - 1572
05/09/2006 ---Box 1 and Box 6 of the FDA Form 1572
06/10/2009 ---BPC- Good Clinical Practice
06/01/2009 ---Breakfast in Fed BE Study
03/18/2015 ---Breaking the Double Blind Study due to Fatal SAE
10/13/2015 ---Brief Name for Clinical Trial
07/23/2012 ---Brother
12/15/2006 ---Budget Question
04/13/2016 ---Buying Meals for Site Staff during Monitoring Visits
09/23/2009 ---By Adding Unaffiliated Lab to 1572, Does PI Become Responsible for Lab's Actions?
04/15/2012 ---Calibration Frequency of Instrument Used in Clinical Trail
11/30/2011 ---California Bill of Rights
11/16/2011 ---California Bill of Rights for Human Subject Experimentation
08/10/2010 ---Call Re informed consent waivers
03/31/2009 ---Can an IND be Necessary for the Study of a Medical Food
05/22/2006 ---Can An Investigator Have More Than One Site?
07/24/2009 ---Can a Patient's Local Physician Conduct Study Visits
10/22/2008 ---Can a Research Nurse Repackage a Controlled Substance Drug
09/01/2016 ---Can a Sub-Investigator Perform all Study Related Responsibilities in Absence of Investigator
11/04/2016 ---Can a Sub-Investigator Perform all Study Related Responsibilities in Absence of Investigator
04/18/2006 ---Can a Subinvestigator Work for Two Principal Investigators?
03/14/2011 ---Cancer Biomarker Inquiry
10/28/2015 ---Can Date Be Written By a Research Staff on PI 's Behalf or a Date Stamp can be Used
09/16/2011 ---Can Date Be Written by a Research Staff on PI 'S Behalf or a Date Stamp Can Be Used?
08/18/2003 ---Can FDA inspect financial disclosure information?
10/01/2003 ---Can FDA inspect financial disclosure information?
11/10/2010 ---Can Ionizing Radiation be Approved via Expedited Review
03/24/2008 ---Can IRBs Require CIs to Disclose Financial Links
11/19/2009 ---Can LAR Sign as Impartial Witness
07/11/2003 ---Can MDs with expired licenses serve as CIs?
09/22/2008 ---Can Monitors Have Direct Contact with Subjects
04/03/2009 ---Can Monitors Make Entries on CRFs
06/23/2003 ---Cannot Locate Section 5.5.12
07/30/2015 ---Can Nurses Determine Clinical Significance of Lab Values for a Clinical Trial
08/03/2007 ---Can RN Perform Physical Exams
02/01/2008 ---Can Sponsor Charge Less
09/13/2007 ---Can Sponsor Investigators Administer Content
09/08/2008 ---Can Study Material be Used Prior to ICF
12/05/2012 ---Can Subject Correct Consent
01/19/2012 ---Can this Registry Study not have a Consent Form
03/19/2010 ---Can Wards of the State be included in Clinical Investigations?
10/02/2015 ---Can you give Us Guidance Please?
12/09/2004 ---Can you help?
12/09/2004 ---Can you help?
12/10/2002 ---Capacity to Consent
12/12/2007 ---CAP and CLIA Laboratory Certifications
10/14/2016 ---CAPA Template??
03/22/2006 ---Capturing AEs After a Subject Signs the Informed Consent, but Prior to Administration of a Pharmaceutical Product
01/18/2013 ---Caregiver Consent
05/04/2007 ---Caregiver Informed Consent
08/14/2015 ---Care Outside of Research Protocol
04/09/2002 ---case book signatures
12/08/2006 ---Case Report Form Binder / Medical Records
05/13/2013 ---Case Report Form Retention at the Study Site
05/23/2006 ---Case Report Forms
02/13/2011 ---Case Report Forms
05/03/2007 ---Case Report Forms and Source Document Forms
04/13/2005 ---Case Report Forms as Source
02/12/2004 ---Case Report Forms as Source Documents
11/01/2006 ---Case Studies for Educational Program on the Informed Consent Process
03/21/2006 ---Causality Assessments Defined
10/01/2009 ---Causality Question- 2
04/30/2012 ---CBER Inspections
05/30/2002 ---CCRC
05/31/2012 ---CD Copies of Electronic Data Sent to Clinical Investigators at End of Study
07/20/2006 ---CDRH's website and inspection statistics
06/04/2014 ---CDRH Domestic and Foreign Clinical Investigator routine BIMO Inspections
10/13/2006 ---CDRH GCP inspections
10/16/2006 ---CDRH GCP inspections
11/08/2010 ---CDRH New Update
02/22/2013 ---Central Facilities on the 1572
10/15/2004 ---Central Files
01/27/2010 ---Central IRB Acquisitions
07/05/2005 ---Central IRB continuing review
05/24/2007 ---Central IRB FDA Issue
10/14/2005 ---Central IRB Moving
01/09/2007 ---Central IRB Moving
05/04/2009 ---Central IRB Reference
11/12/2012 ---Central IRBs
10/04/2002 ---Central Lab question
03/22/2007 ---Certificate of Analysis
04/28/2009 ---Certificate of Analysis for Investigational Drug
05/24/2004 ---Certificate of Confidentiality
01/18/2006 ---Certificate of Confidentiality
04/07/2009 ---Certificate of Confidentiality
05/26/2015 ---Certificate of Confidentiality
10/31/2007 ---Certificate of Translation for Foreign Site Documents in Clinical Trials Under an IND
05/10/2002 ---Certificate program available?
05/30/2007 ---Certificates of Analyses
10/14/2005 ---Certificates of Confidentiality
11/07/2007 ---Certification
07/02/2015 ---Certification
09/14/2006 ---Certification Exam
09/02/2005 ---Certification of adherence to GCP
02/17/2004 ---Certification of Clinical Trials Center
02/18/2004 ---Certification of Clinical Trials Center
02/18/2004 ---Certification of Clinical Trials Center
05/18/2009 ---Certification Question
08/28/2013 ---Certifications and Training
04/04/2007 ---Certified Clinical Research - Certification
12/30/2001 ---Certified copies
09/30/2004 ---Certified copies
10/15/2007 ---Certified Copies
04/27/2009 ---Certified Copies
08/10/2009 ---Certified Copies
05/17/2011 ---Certified Copies
11/10/2015 ---Certified Copies
03/29/2012 ---Certified Copies of Medical Records
04/12/2004 ---Certified copy of source documents
04/06/2004 ---Certified Foreign Clinical Trials Sites
06/18/2014 ---Certified Letters to Study Subjects Lost to Follow-up
10/17/2003 ---Certified Translations
11/07/2013 ---CFDA
04/29/2009 ---CFR 312.30 Question
03/08/2010 ---CFR 312.32
11/12/2004 ---CFR 312.62 Record Retention
10/19/2016 ---CFR 812.43 Question - Participating Investigator
02/07/2012 ---CFR Development Question
04/24/2008 ---CFR Fed Reg IHC Guidelines
12/11/2007 ---CFR Part 11
03/08/2004 ---CFR Subpart D - 312.52 - Transfer of Obligations to CRO
08/11/2009 ---CFR SubPart D 312.52 - Central Labs and Transfer of Obligation
06/08/2009 ---cGMP for Device Studies
06/18/2002 ---cgp implementation guidelines for cro's
05/15/2007 ---Chain of Custody-Tissue Samples
03/23/2011 ---Change in Address
11/01/2005 ---Change in IRB
06/21/2005 ---Change in Organization
08/20/2002 ---Change in Protocol
03/01/2007 ---Change in Site Address
05/12/2003 ---Change of Address
04/09/2008 ---Change of Address
05/20/2013 ---Change of Address Question
12/20/2007 ---Change of Address Records
05/30/2007 ---Change of IEC for Extended Study
11/18/2009 ---Change of Investigator
07/27/2007 ---Change of Principal Investigator
04/05/2005 ---Change of Sponsor
03/10/2010 ---Change of Sponsor for IND
02/23/2012 ---Changes in Clinical Laboratories
07/15/2009 ---Changes in Study Coordinator On 1571
06/14/2010 ---Changes Regarding EC approval
03/24/2009 ---Changes to 1572 Form
12/29/2014 ---Changes to a 1572
05/12/2008 ---Changes to Records
06/07/2010 ---Change to FDA 1572
11/26/2010 ---Changing Data Collected in a Clinical Trial
06/11/2003 ---Charges for investigational drugs
12/13/2007 ---Charging for Investigational Drug in an Investigator-Sponsored IND Exempt Study
09/18/2006 ---Charging for Investigational Drugs in a Phase 4 Study
02/19/2004 ---Charging for Research Procedures
02/10/2015 ---Charity Responsibility
07/17/2007 ---Child Assent Question
01/13/2011 ---Child Assent Question
01/16/2007 ---Child Reaching Age of Majority
11/30/2007 ---Child Resistant Package
01/28/2003 ---Choice of Medical Monitor for clinical trials
08/12/2008 ---Choosing an IRB Financial Disclosure and Reading Levels of ICDs
02/18/2011 ---Chronic Back Pain
06/11/2008 ---CI- Inspection List
10/23/2010 ---CI Certification
10/29/2009 ---CI Deficiencies
09/25/2009 ---CI Financial Interests
04/04/2011 ---CI Inspection Findings to IRB
09/28/2007 ---CI Not Acceptable
05/29/2012 ---CIOMS Reviewing by Investigators and IRB
01/26/2011 ---CI Right/Ability to Review IRB Meeting Minutes
06/30/2004 ---CI Signature on Clinical Trial Records
03/22/2006 ---Citation of FDA web Page not found
02/22/2011 ---CITI GCP Online Training Program
11/29/2013 ---Citing Risks in a Registry Study
01/14/2011 ---CITI Training
10/28/2009 ---Claims for Therapies Chiropractic Strokes
11/18/2003 ---Clarification
12/15/2003 ---Clarification
03/15/2006 ---A Clarification
08/20/2002 ---Clarification: telephone scripts
01/08/2014 ---Clarification about Safety Reporting requested from [Redacted] Laboratories
11/02/2012 ---Clarification Needed
06/10/2016 ---Clarification needed on ADE vs. AE
09/01/2010 ---Clarification Needed Regarding IRB Reporting Suspension of Enrollment
08/25/2007 ---Clarification of 21 CFR 56.109(c)(1)
11/21/2007 ---Clarification of Definition of a Sponsor
05/02/2008 ---Clarification of Emergency Use for Medical Devices
11/13/2012 ---Clarification of IND Regulations at 21 CFR 312.20(b)
05/22/2012 ---Clarification of IRB details
03/01/2011 ---Clarification of New Safety Regs
08/24/2011 ---Clarification of Recordkeeping
11/27/2013 ---Clarification of Serious Adverse Event Definition
02/23/2006 ---Clarification of Terminology
03/11/2010 ---Clarification on 1572 Related
11/25/2002 ---Clarification on Exculpatory Language
09/28/2006 ---Clarification on FDA Stand on Specific Language as "Appears to be Exculpatory"
03/15/2010 ---Clarification on Form no. 3454 3455
06/01/2009 ---Clarification on Guidance Regarding Reporting Adverse Events
11/18/2005 ---Clarification on IRB Expedited Review
04/02/2010 ---Clarification on IRB non-scientific members
02/28/2003 ---Clarification on NDA
06/01/2009 ---Clarification on Quorum at an IRB Meeting
01/18/2011 ---Clarification re Confidentiality
03/14/2011 ---Clarification regarding FDA Interpretation of ICH/GCP 4.3.2 and 4.9.1
05/17/2012 ---Clarification regarding IRB Continuing Review
10/01/2012 ---Clarification Request
06/04/2013 ---Clarification requested
01/08/2015 ---Clarification Requested on Subjects DOB Data Allowed to be Collected per Local Regulations
12/08/2010 ---Clarifications
05/18/2015 ---Clarifications
11/11/2011 ---Clarifications Requested Regarding Monitoring Practices Adequacy per ICH GCP Rules
11/11/2011 ---Clarifications Requested regarding Monitoring Practices Adequacy per ICH GCP Rules
11/13/2009 ---Clarifying 21 CFR 312.62(b) and Re-consenting for Revised ICF
07/18/2014 ---Clarity
07/21/2010 ---Clarity on who can be LAR and who can be Impartial Witness
03/04/2013 ---Classification of Study Sites Based on PI IRB and Proximity
09/14/2005 ---CLIA
08/12/2010 ---CLIA/CAP certificates
03/28/2011 ---CLIA and CAP Certificate Requirement for PK Tests
02/25/2008 ---CLIA and GLPs
05/18/2006 ---CLIA Certification
12/21/2012 ---CLIA Section 4 and Waived Tests
12/21/2012 ---CLIA Section 4 and Waived Tests
11/15/2006 ---CLIA vs. CAP
01/08/2015 ---CLIA Waived Tests FU Question
09/30/2014 ---CLIA Waiver
04/14/2014 ---CLIA Waiver for Research Testing?
09/26/2007 ---CLIA Waiver Question
08/12/2014 ---CLIA Waiver Requirement
12/01/2011 ---Client with Data Collection Registry
06/21/2007 ---Clinical Complaint Definition
05/29/2008 ---Clinical Data Archiving (Archival Grade CD DVD)
12/18/2013 ---Clinical Database AE Cut-Off Dates
12/07/2004 ---Clinical Data Reporting Question
11/30/2006 ---Clinical Document Archiving
12/07/2007 ---Clinical Drug Labeling Requirements in USA
05/14/2012 ---Clinical for Supplements
04/26/2013 ---Clinical Hold/Temporary Termination of Clinical Trials with Medical Devices
07/02/2008 ---Clinical Investigations
02/22/2012 ---Clinical Investigator Inspection List
06/01/2015 ---Clinical Investigator Inspection List
01/15/2013 ---Clinical Investigator Inspection Search
06/28/2010 ---Clinical Investigator Requirements
03/03/2010 ---Clinical Investigator Requirements Question
03/03/2010 ---Clinical Investigator Requirements Question
05/03/2011 ---Clinical Investigators
01/24/2008 ---Clinical Investigator Working on Competing Drugs
08/09/2002 ---Clinical Lab certification?
08/01/2005 ---Clinical Laboratories
09/05/2008 ---Clinical Laboratories- What Standards Does FDA Have?
04/03/2012 ---Clinical Laboratories and GCP/GLP
08/27/2002 ---Clinical laboratories in FDA-regulated research
10/02/2015 ---Clinical Laboratories Supporting Clinical Trials
04/03/2007 ---Clinical Laboratory
08/22/2007 ---Clinical Laboratory Analyses in Clinical Trials
09/05/2007 ---Clinical Laboratory Analyses in Clinical Trials
04/01/2009 ---Clinical Laboratory Inspections
07/06/2009 ---Clinical Laboratory Regulations
03/16/2007 ---Clinical Laboratory Standards
07/15/2015 ---Clinical Laboratory Testing Guidance for Clinical Trials
06/22/2011 ---Clinical Lab Record Retention Requirements for NSR Device Study Data
07/31/2009 ---Clinically Significant Lab Values
05/02/2006 ---Clinical Monitor
01/23/2014 ---Clinical Participant
05/08/2002 ---Clinical Pharmaceutical Research Activities
02/20/2002 ---Clinical Phase I Manufacturing
11/19/2004 ---Clinical Protocol Review
12/10/2011 ---Clinical Question
06/29/2007 ---Clinical Record Keeping Requirements
08/05/2008 ---Clinical Research
01/25/2010 ---Clinical Research
12/20/2005 ---Clinical Research (Principal Investigator)
12/28/2005 ---Clinical Research (Principal investigator)
02/11/2010 ---Clinical Research - Documentation of Training to the Sites
09/11/2009 ---Clinical Research- Sponsor Provided Source Documents
04/27/2016 ---Clinical Research Adequate Resources
05/19/2005 ---Clinical Research and Adequate Source Documentation
12/23/2009 ---Clinical Research and Source Documents
09/30/2004 ---Clinical Research Associate Certification
09/22/2004 ---Clinical Research Association Information
10/04/2005 ---Clinical Research Audit
04/28/2006 ---Clinical Research Coordinator
10/12/2005 ---Clinical research Coordinators
05/17/2013 ---Clinical Research Device Trials
03/07/2011 ---Clinical Research Drug Study
01/11/2011 ---Clinical Research Education
01/11/2011 ---Clinical Research Education
03/29/2002 ---Clinical Research Guidelines
06/19/2002 ---Clinical Research QA Course at FDA
05/12/2014 ---Clinical Research Question
03/26/2010 ---Clinical Research Record Retention Question
11/18/2008 ---Clinical Research Sites
11/08/2007 ---Clinical Research Staffing Question
05/22/2013 ---Clinical Research Staff Training Documentation
05/24/2013 ---Clinical Research Staff Training Documentation
02/13/2009 ---Clinical Research Student Need Help to Find Info
10/07/2011 ---Clinical Research Trials
12/04/2003 ---Clinical safety question
05/26/2004 ---Clinical samples & GLP
10/15/2012 ---Clinical Site Data Elements Summary Listing
04/09/2009 ---Clinical Site Moving
11/18/2011 ---Clinical Sites
02/03/2009 ---Clinical Sites Location
05/25/2011 ---Clinical Sites Using Pencil Vs Pen
04/19/2006 ---Clinical Sites with Satellite Sites
05/13/2013 ---Clinical Site Termination
05/29/2002 ---Clinical Site Validation and Accreditation Process
06/16/2014 ---Clinical Site Website
05/26/2011 ---Clinical Studies and/or Studies
04/29/2005 ---Clinical studies in Russia
08/07/2012 ---Clinical Studies Questions
01/30/2013 ---Clinical Studies Questions
07/02/2008 ---Clinical Studies Record Keeping
01/28/2015 ---Clinical Study
08/22/2008 ---Clinical Study- Weight Loss
08/29/2013 ---Clinical Study Data Standards
08/29/2013 ---Clinical Study Data Standardsat
07/23/2007 ---Clinical Study Education
05/30/2014 ---Clinical Study Monitors Present during FDA Inspection
04/14/2006 ---Clinical Study Monitor Training Requirements
04/06/2016 ---Clinical Study Report
03/20/2009 ---Clinical Study Reports- Listing Investigators Who Did Not Enroll Subjects
07/24/2008 ---Clinical Study Results Database
09/08/2010 ---Clinical Study Subject Withdrawal Consequence for Specimens Obtained
12/03/2009 ---Clinical Study with Safety Board Charter Needed
08/26/2014 ---Clinical Supplies
09/15/2003 ---Clinical Supply Maintenance
06/18/2002 ---Clinical testing in [redacted]
02/24/2005 ---Clinical Trails Diaries - CRF
11/15/2004 ---Clinical Training
06/27/2002 ---Clinical Trial
06/13/2003 ---Clinical Trial
04/07/2004 ---Clinical Trial
07/14/2006 ---Clinical Trial
01/11/2007 ---Clinical Trial
09/22/2008 ---Clinical Trial
10/23/2010 ---Clinical Trial
11/01/2010 ---Clinical Trial
05/11/2015 ---Clinical Trial
04/16/2013 ---Clinical Trial, Regulatory Questions
03/22/2012 ---Clinical Trial - GCP Requirement when Trail Site Changed within Same City
11/19/2004 ---Clinical Trial - HIPAA
02/20/2015 ---Clinical Trial - PI Responsibility Question
10/20/2009 ---Clinical Trial- Subcontractor Liability
12/23/2009 ---Clinical Trial- Subcontractor Liability
03/16/2011 ---Clinical Trial.
06/19/2012 ---Clinicaltrial.gov
02/28/2011 ---Clinical Trial?
03/29/2013 ---Clinical Trial Agreements and the eTMF
05/07/2010 ---Clinical Trial Amendment and Investigator Amendment Guidance
10/18/2010 ---Clinical Trial Approval
05/21/2010 ---Clinical Trial Asked to Participate in
09/05/2007 ---Clinical Trial Auditor
09/14/2006 ---Clinical Trial Audit Program
01/17/2007 ---Clinical Trial Audits
01/07/2009 ---Clinical Trial Branding Acronyms
11/21/2007 ---Clinical Trial Close-Out Visit
11/18/2011 ---Clinical Trial Close Out
11/13/2006 ---Clinical Trial Complaints
03/09/2006 ---Clinical Trial Conduct Question
05/20/2013 ---Clinical Trial Consent Form
05/31/2007 ---Clinical Trial Data
04/23/2013 ---Clinical Trial Data Archive
02/26/2013 ---Clinical Trial Document Archival
01/18/2012 ---Clinical Trial Documentation Question
01/04/2013 ---Clinical Trial Document Retention
01/25/2012 ---Clinical Trial Drug Regulations
03/18/2005 ---Clinical Trial Education
06/14/2013 ---Clinical Trial Enrollment-Enrolling Patients from Other Countries.
11/05/2008 ---Clinical Trial for Hep C
06/04/2004 ---Clinical Trial GCP Questions
01/29/2011 ---Clinical Trial Info
01/29/2004 ---Clinical Trial Information
08/09/2006 ---Clinical trial information
02/14/2014 ---Clinical Trial Information
09/11/2006 ---Clinical trial information (2)
09/16/2011 ---Clinical Trial in Puerto Rico
05/19/2012 ---Clinical Trial Investigators
12/01/2005 ---Clinical Trial Length
06/06/2011 ---Clinical Trial or Patient Survey
06/12/2013 ---Clinical Trial Participation
10/14/2003 ---Clinical Trial patient database
05/05/2003 ---Clinical Trial phase information
05/06/2008 ---Clinical Trial Phases
01/14/2009 ---Clinical Trial Practices
11/24/2009 ---Clinical Trial Process
07/01/2004 ---Clinical Trial Product
11/25/2008 ---Clinical Trial Protocol - Regional Differences
11/07/2002 ---Clinical Trial Protocols - side effects
07/18/2013 ---Clinical Trial Query
04/04/2002 ---clinical trial question
04/19/2005 ---Clinical Trial Question
06/23/2010 ---Clinical Trial Question
10/11/2012 ---Clinical Trial Question
07/02/2014 ---Clinical Trial Question
03/27/2015 ---Clinical Trial Question
03/07/2013 ---Clinical Trial Question (IRB oversight)
04/10/2002 ---Clinical Trial Questions
04/15/2002 ---Clinical Trial Questions
02/20/2007 ---Clinical Trial Record Keeping
01/06/2011 ---Clinical Trial Record Retention
03/18/2013 ---Clinical Trial Record Storage
06/17/2005 ---Clinical Trial Referrals
04/14/2008 ---Clinical Trial Registration
11/19/2009 ---Clinical Trial Registration
06/29/2016 ---Clinical Trial Registration
05/17/2013 ---Clinical Trial Registries
01/20/2010 ---Clinical Trial Registry
01/07/2010 ---Clinical Trial Registry #
06/27/2005 ---Clinical Trial Regulations
03/04/2008 ---Clinical Trial Regulations
01/09/2016 ---Clinical Trial Regulations
12/05/2016 ---Clinical Trial Related ICF Question
03/24/2011 ---Clinical Trial Rules
05/30/2002 ---Clinical trials
09/18/2002 ---clinical trials
10/04/2002 ---Clinical trials
07/25/2003 ---Clinical Trials
09/02/2003 ---Clinical trials
09/03/2003 ---Clinical Trials
09/15/2003 ---Clinical Trials
11/10/2003 ---Clinical trials
05/13/2004 ---Clinical Trials
05/13/2004 ---Clinical Trials
08/20/2004 ---Clinical trials
02/24/2005 ---Clinical Trials
03/09/2006 ---Clinical Trials
06/12/2006 ---Clinical Trials
09/05/2006 ---Clinical Trials
01/28/2008 ---Clinical Trials
12/28/2009 ---Clinical Trials
04/07/2010 ---Clinical Trials
04/07/2010 ---Clinical Trials
04/22/2010 ---Clinical Trials
05/17/2010 ---Clinical Trials
12/13/2011 ---Clinical Trials
01/24/2012 ---Clinical Trials
05/06/2012 ---Clinical Trials
05/09/2012 ---Clinical Trials
11/20/2012 ---Clinical Trials
06/17/2013 ---Clinical Trials
07/19/2013 ---Clinical Trials
05/11/2015 ---Clinical Trials
02/11/2010 ---Clinical Trials (GCP) - Medical History
02/11/2010 ---Clinical Trials (GCP) - Medical History
07/03/2007 ---Clinical Trials- AE
10/21/2011 ---Clinical Trials - AE Assessments
10/03/2005 ---Clinical trials - being seen by the investigator post-study completion
09/22/2004 ---Clinical trials - Drug Accountability Log
03/03/2005 ---Clinical Trials - Meaning of "All Participating Investigators
10/26/2006 ---Clinical Trials- Signed Consent Form
10/31/2006 ---Clinical Trials- Signed Consent Form
07/05/2006 ---Clinical Trials- Source Data
11/05/2009 ---Clinical Trials- Sponsor Demand
09/07/2007 ---Clinical Trials- Sub-Investigators
04/30/2013 ---Clinical Trials - Technical Question about Patient Transfer
01/28/2009 ---Clinical Trials - Trial Master files - Correspondence Files
05/23/2007 ---Clinical Trials- Under the Influence of a Narcotic
09/13/2012 ---Clinical Trials - [Redacted]
09/03/2004 ---Clinical Trials...
09/21/2004 ---Clinical Trials...
06/19/2007 ---Clinicaltrials.gov
08/14/2012 ---ClinicalTrials.gov
01/23/2013 ---ClinicalTrials.gov
11/22/2013 ---clinicaltrials.gov
03/27/2013 ---Clinicaltrials.gov Compliance
01/24/2014 ---ClinicalTrials.gov Language
01/13/2015 ---Clinicaltrials.Gov Language
08/16/2011 ---Clinicaltrials.gov Question
05/20/2016 ---ClinicalTrials.gov Statement Question
09/29/2015 ---Clinicaltrials.gov Studies Considered to be FDA Registered Trials
09/03/2014 ---Clinical Trials.gov Text Question
06/07/2013 ---Clinical Trials: Letter to Lost to Followup Patients
03/29/2010 ---Clinical Trials and Electronic Health Records
02/02/2016 ---Clinical Trials and Ethnicity
01/09/2014 ---Clinical Trials and Human Subject Protection
12/15/2014 ---Clinical Trials and Ordering of Tests
07/13/2006 ---Clinical Trial Screening
02/09/2015 ---Clinical Trials Database Question - MS Excel
03/26/2010 ---Clinical Trials Definition
08/05/2009 ---Clinical Trials Drug Labeling
06/14/2012 ---Clinical Trials Educational Material
07/19/2006 ---Clinical Trials Follow-Up
05/31/2012 ---Clinical Trials for Cosmetics
08/06/2004 ---Clinical trials for [Redacted]
02/17/2009 ---Clinical Trials for [Redacted} Medications Do Not Test on [Redacted]
07/18/2005 ---Clinical Trials in Foreign Countries
07/19/2005 ---Clinical Trials in Foreign Countries
08/23/2004 ---Clinical Trials Information
03/24/2010 ---Clinical Trials Informed Consent/Authorization to Use and Disclose PHI - language question
11/05/2015 ---Clinical Trials in Preterm Infants
10/18/2007 ---Clinical Trials in Puerto Rico
06/02/2015 ---Clinical Trials involving Dietary Supplements
02/25/2014 ---Clinical Trial Site
05/03/2012 ---Clinical Trial Sites
05/31/2005 ---Clinical Trial Site Selection
04/06/2016 ---Clinical Trial Site Training Documentation
09/04/2012 ---Clinical Trials List
10/05/2009 ---Clinical Trials Not Regulated by FDA
01/19/2010 ---Clinical Trials of Marketed Approved Drugs Noncompliance Clarification
04/07/2016 ---Clinical Trial Software Qualification
10/20/2015 ---Clinical Trials on Hold
11/27/2012 ---Clinical Trial Source Documentation Question
08/25/2009 ---Clinical Trial Source Document Record Release Question
05/29/2009 ---Clinical Trials Outside of the United States
06/02/2009 ---Clinical Trials Outside of the United States 2
06/03/2009 ---Clinical Trials Outside of the United States 3
07/10/2009 ---Clinical Trials Phases
02/09/2007 ---Clinical Trials Phases for IVDs
07/09/2008 ---Clinical Trials Process
09/16/2003 ---Clinical Trials Question
09/16/2003 ---Clinical Trials Question
03/19/2004 ---Clinical Trials Question
04/20/2004 ---Clinical Trials Question
12/09/2004 ---Clinical Trials Question
08/07/2013 ---Clinical Trials Question: Can Siblings Enroll in Same Trial?
09/10/2007 ---Clinical Trials Regs
07/03/2008 ---Clinical Trials Reporting Guidelines
05/08/2009 ---Clinical Trials State Requirements
03/05/2008 ---Clinical Trial Studies
05/20/2008 ---Clinical Trial Studies
02/07/2013 ---Clinical Trial Study Delivery of Investigational Medicinal Product to Patients Home
03/15/2006 ---Clinical Trial Study Site Recognition Programs
05/06/2005 ---Clinical Trial Subject Participation
08/28/2006 ---Clinical Trials Website
07/10/2009 ---Clinical Trials Website and CIOMs
08/30/2007 ---Clinical Trials with Investigator Sites in Iran
07/24/2009 ---Clinical Trials with Special Populations
10/18/2012 ---Clinical Trial to Collect Information
02/16/2010 ---Clinical Trial Volunteers
07/21/2006 ---Clinical Trial Workshop in November
08/11/2006 ---Clinical values out-of-range
12/27/2007 ---Close of Study
07/22/2016 ---Closeout Visit
07/22/2016 ---Closeout Visit
04/03/2007 ---Close Out Visit Monitor Checklist
12/02/2008 ---Close Relatives in the IRB
07/15/2016 ---Closing Out a Clinical Site Following Completion of All Subject Visits
06/22/2009 ---Closure of a Study Before All Subjects Have Completed
02/15/2007 ---Closure of CRO
01/05/2003 ---Closure question
09/02/2016 ---Cloud Storage
06/18/2002 ---Co-Investigators
11/04/2013 ---Co-Investigators versus Sub-Investigators
03/15/2011 ---Co-I vs Sub-I
07/10/2014 ---Co-PI 1572 Form
10/12/2011 ---Co-Principal Investigators
08/03/2004 ---COC
08/24/2004 ---COC
08/30/2004 ---COC with consent form
07/29/2010 ---Code of Federal Regulations
07/05/2007 ---Code of Federal Regulations and Good Clinical Practices
12/07/2012 ---Code of Federal Regulations Title 21 - PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
11/25/2002 ---A colleague has referred me to you directly
06/14/2011 ---Collecting AEs in Device Trials
06/18/2009 ---Collecting Twice for Clinical Study Procedures
10/05/2007 ---Collecting Twice for Single Procedure
01/04/2014 ---Collection and Reporting of Run-in Data
04/15/2005 ---Collection Medical History Data for Subjects
01/23/2014 ---Collection of CLIA Waived Certification for Urine Pregnancy Tests
07/05/2011 ---Collection of Documents at Close-out Visits
01/15/2016 ---Collection of f/u Data Post Withdrawal
01/21/2016 ---Collection of F/U Data Post Withdrawal
12/07/2012 ---Collection of Lab Director's CV and Licensure
08/06/2008 ---Comments 1572 Guidance
10/13/2014 ---Comments on Informed Consent Information Sheet
05/29/2014 ---Commercial Drug that is Subject of Sponsor's IND Study Belongs to Another Company
02/06/2013 ---Commercially Available Product vs. Investigational Drug
07/11/2002 ---communication
02/23/2015 ---Communication Consultation Plan Prior to IND
06/20/2003 ---Communication documentation
04/10/2012 ---Communication Records
05/30/2012 ---Community Trial Question
10/20/2004 ---Company Name Change
06/16/2009 ---Comparison of 2 FDA Approved Products
11/20/2012 ---Comparison of FDA and HHS regulations
10/02/2015 ---Compassionate Devise Use
11/16/2007 ---Compassionate Use
06/24/2015 ---Compassionate Use - Question regarding Process
08/12/2011 ---Compassionate Use Protocol
08/12/2011 ---Compassionate Use Protocol
08/30/2011 ---Compassionate Use Protocol (Expanded Access ICF Requirement)
09/02/2005 ---Compensation Caps for CIs
02/06/2007 ---Compensation for Study Participation
02/10/2012 ---Compensation in Clinical Trials
12/26/2016 ---Compensation Issues - Clinical Trials
03/31/2011 ---Compensation Medication for the Patients in Placebo Controlled Group
07/11/2011 ---Compensation to Subjects participating in a Clinical Trial
06/11/2014 ---Competent Subject Capable of Granting Consent but Physically Unable to Sign or Make a Mark?
03/25/2008 ---Complaint Acknowledgments
10/05/2007 ---Completion Box 6
05/18/2010 ---Completion of 1572
09/20/2012 ---Completion of 1572 - Home Blood Draws
09/21/2012 ---Completion of 1572 - Home Blood Draws
05/06/2015 ---Completion of 1572 by foreign investigators
01/12/2012 ---Completion of 1572...Box 8
10/31/2005 ---Completion of clinical trial
07/09/2010 ---Completion of CRFs
09/08/2014 ---Completion of ICF and Individual Insurance Policy Number
09/30/2005 ---Completion of the Form FDA 1572
10/03/2005 ---Completion of the Form FDA 1572
12/24/2014 ---Compliance/PHI Question for Clinical Trial
02/24/2011 ---Complianceonline.training
03/30/2004 ---Compliance Question
01/04/2005 ---Compliance Question
07/01/2008 ---Compliance Question
06/04/2013 ---Compliance Question
12/24/2014 ---Compliance Question
02/06/2003 ---Compliance Question - Protocol Deviations/Violations
03/14/2003 ---Compliance Question - Protocol Deviations/Violations
07/24/2008 ---Compliance Questions
08/20/2010 ---Compliance Questions
04/09/2007 ---Compliance Questions- AE and Filing of Amendments
12/23/2009 ---Compliance Questions for Research
02/04/2003 ---Compliance Questions for the OGCP
11/28/2012 ---Compliance Statement
11/16/2011 ---Compliance Verification
01/22/2015 ---Component Analysis
08/09/2002 ---Computer assistance in clinical trial
06/15/2006 ---Computerized Systems
01/28/2008 ---Computerized Systems
04/20/2005 ---Computerized Systems Used in Clinical Trials
01/09/2006 ---Computerized Systems Used In Clinical Trials
04/10/2006 ---Computerized Systems Used In Clinical Trials (FDA 21 CFR part 11)
08/01/2006 ---Computerized Systems Used In Clinical Trials (FDA 21 CFR part 11)
02/16/2007 ---Computerized Systems Used In Clinical Trials (FDA 21 CFR part 11)
09/04/2002 ---Computer Systems
08/25/2014 ---Computer System Validation used in Sensory Studies
12/05/2012 ---Concept of Deviation and Violation of Protocol
05/17/2010 ---Concerning Mid-level Providers and Role in Research
03/21/2008 ---Concomitant Medications
07/11/2007 ---Concomittant Meds
02/21/2011 ---Conditional or Provisional IRB Approval
12/15/2010 ---Conditions of Approval Study Requirements
02/16/2012 ---Conducting a Clinical Study Evaluating a Non-FDA Approved Drug Dosage
05/05/2009 ---Conducting Clinical Trials out of Home Office of the PI
10/01/2007 ---Conducting Device Trial
05/09/2012 ---Conducting Remote Visits
03/21/2004 ---Conducting Research for a Master's Thesis
03/10/2004 ---Conducting Research for Master's Thesis
02/05/2008 ---Confidential Disclosure Agreement
08/12/2009 ---Confidentiality
07/13/2012 ---Confidentiality
04/25/2008 ---Confidentiality Violation
10/08/2004 ---Confirmation
03/27/2003 ---Confirmation of Contact Information
06/25/2015 ---Confirmation of CRF Requirements Date of Birth
08/04/2008 ---Conflicted Chair
11/29/2004 ---Conflict of Interest
11/29/2004 ---Conflict of Interest
03/23/2005 ---Conflict of Interest
03/04/2011 ---Conflict of Interest
08/24/2011 ---Conflict of Interest
11/28/2012 ---Conflict of Interest
02/10/2016 ---Conflict of Interest + Deviation
12/21/2005 ---Conflict of Interest/FDA Guidelines?
01/10/2012 ---Conflict of Interest?
05/10/2010 ---Conflict of Interest and Quorum
05/10/2010 ---Conflict of Interest and Quorum
01/14/2013 ---Conflict of Interest Doubt
04/23/2002 ---Conflict of Interest in Clinical Trials
04/25/2002 ---Conflict of Interest in Clinical Trials
11/19/2013 ---Conflict of Interest Query
11/12/2004 ---A Conflict of Interest Question
11/15/2004 ---Conflict of Interest Question
02/28/2005 ---Conflict of interest question
02/28/2005 ---Conflict of interest question
12/19/2011 ---Conflict of Interest Question
09/03/2009 ---Conflict Resolved- When Can Member Resume Voting
01/30/2013 ---Conflicts of Interest and Obtaining Consent
03/01/2005 ---Conflicts of Interest with Principal Investigators
04/10/2002 ---Conformity to Common Rule
01/03/2008 ---Congressional Investigator Request for IRB Records
07/15/2003 ---Coninvestigator signature on 1572
04/08/2015 ---Con Meds
10/14/2008 ---Consecutive Amendments and IRB Review
07/24/2003 ---Consent
09/16/2008 ---Consent
06/10/2011 ---Consent
06/22/2011 ---Consent
08/23/2011 ---Consent
12/11/2013 ---Consent and FDA Form 1572
12/17/2010 ---Consent and Re-screening
06/20/2008 ---Consent by Telephone
11/05/2008 ---Consent Delegation Question
03/04/2013 ---Consent Element regarding Alternative Treatments with Risks/Benefits
08/21/2002 ---Consent Form
05/22/2007 ---Consent Form
11/24/2006 ---Consent Form- Coercive Language
04/25/2002 ---Consent form changes
06/30/2014 ---Consent Form Completed with Incorrect Information in a Response
03/24/2009 ---Consent Form Question
02/25/2014 ---Consent Form Question
10/07/2016 ---Consent Form Question
02/18/2010 ---Consent Form Revision
02/15/2007 ---Consent Form Revisions
10/24/2012 ---Consent Forms
10/25/2012 ---Consent Forms (2)
05/20/2008 ---Consent Form Safety Updates- Enrollment of New Subjects
09/22/2008 ---Consent Form Signatures Dates
02/13/2009 ---Consent Form Translation and Back Translation
01/31/2012 ---Consent from a LAR
06/30/2006 ---Consenting
05/08/2013 ---Consenting Female Partners of Male Subjects
12/14/2009 ---Consenting Illiterate English-Speaking Subjects
10/07/2013 ---Consenting of Patients with Physical Impairment
10/19/2010 ---Consent Notes
10/01/2007 ---Consent of Competent of Child
10/26/2015 ---Consent of Non-English Speaking Subjects
03/24/2003 ---Consent Process
11/05/2009 ---Consent Process
12/04/2014 ---Consent Process Documentation
10/10/2012 ---Consent Process for Visually Impaired Research Subject
08/08/2013 ---Consent Process when Patients Eyes Dilated
12/10/2002 ---consent question
06/21/2010 ---Consent Question
01/12/2012 ---Consent Question
03/21/2016 ---Consent Question
12/29/2016 ---Consent Question - Appendices
05/14/2008 ---Consent Related Questionn- ICHGCP Guidelines
07/29/2010 ---Consent Requirements
11/04/2009 ---Consent Requirements for Registries
07/23/2007 ---Consent Requirements for Studies Exempt from IND and IDE and Under Emergency Use
01/02/2009 ---Consents for Sub-studies
03/26/2009 ---Consent Signature Question
07/25/2012 ---Consent Signatures
07/25/2012 ---Consent Signatures
08/14/2012 ---Consent Signatures
06/17/2009 ---Consent Storage Requirements
05/03/2016 ---Consent Summary Only in English for Non-English Subject
01/13/2010 ---Consultation
02/08/2010 ---Consultation
02/21/2010 ---Consultation
08/07/2012 ---Consultation
03/09/2010 ---Consultation on Clinical Trial
03/09/2010 ---Consultation on clinical trial
04/01/2009 ---Consulting Laboratories
03/18/2003 ---Contact Dr David Lepay
03/30/2004 ---Contacting Subjects Primary MD
07/10/2003 ---Contacts at FDA
11/03/2008 ---Container Labels
03/03/2008 ---Continuation of Participation- Incarcerated Subjects
12/10/2002 ---Continuing informed consent documentation
12/22/2008 ---Continuing Review
06/23/2009 ---Continuing Review
10/01/2010 ---Continuing Review
04/25/2008 ---Continuing Review- Approval Period
05/29/2012 ---Continuing Review - Enrollment
11/29/2006 ---Continuing Review and Emergency IND
03/15/2010 ---Continuing Review approval question
12/07/2006 ---Continuing Review by IRBs
11/08/2007 ---Continuing Review During Data Analysis
03/19/2004 ---Continuing Review in Multi-National IND Research
11/01/2005 ---Continuing Review Lapse
02/09/2009 ---Continuing Review Question
04/29/2007 ---Contraception During Clinical Trials
12/29/2009 ---Contraceptive Alternatives- Informed Consent
11/06/2012 ---Contraceptive Use in Clinical Trials
02/04/2013 ---Contracting and GCP in a Clinical Trial.
04/11/2012 ---Contracting an SMO
05/06/2008 ---Contracting Sponsor Responsibilities
01/27/2014 ---Contract Physician as Principal Investigator
02/11/2009 ---Contracts/Agreements
10/11/2010 ---Contract Study Coordinators
09/30/2005 ---Contractual versus regulatory obligations
03/07/2006 ---Control of Investigational Product
12/29/2004 ---Convened meetings
11/22/2005 ---Convicted Felon Question
03/16/2012 ---Cooperative Trials and Websites for Information
03/27/2007 ---Coordinators in Block 6
09/07/2007 ---Copies of E-Mail Messages
11/09/2006 ---Copies of Signed 1572s
08/28/2015 ---Copy
04/05/2005 ---Copy of 2-2-98 FR Notice
08/11/2016 ---Copy of Consent Documentation
02/17/2009 ---Copy of GCP
03/18/2009 ---Copy of GCP (2)
06/26/2009 ---Copy of GCP Guidelines
10/16/2012 ---Copy of ICF in Patient Medical Record
02/23/2009 ---Copy of Informed Consent Maintained by Participating Subject
12/04/2008 ---Copy of RE Investigator Discontinuation
03/08/2013 ---Corporate Integrity Agreements
03/19/2007 ---Correct a Phone Number in a Protocol
09/08/2009 ---Corrections to eCRFs
02/26/2008 ---Corrections To Inf Cons Doc
02/24/2015 ---Corrections to Signed ICF
07/20/2015 ---Corrective and Preventive Actions
04/27/2005 ---Cosmetic Products
05/04/2007 ---Cosmetics and OTC Monograph Products
05/05/2009 ---Cosmetics Question
11/30/2005 ---Co Sponsorship Agreement
02/09/2013 ---Cost of Clinical Trial
10/10/2003 ---Couple of Issues: Your email of 10/1
09/13/2011 ---Course of Good Practice Clinical
08/31/2009 ---Course on Marketing a Clinical Study
01/28/2014 ---Course Outline-GCP & HSP
09/30/2004 ---Courses
01/07/2005 ---COX-2 studies
06/19/2014 ---CRA Audit Findings
09/24/2003 ---CRA bonuses based on site recruitment rates
09/04/2003 ---CRA certification
11/18/2011 ---CRA Completing CRFs
03/16/2016 ---CRA not Allowed to Spot Check Site's EMR to ensure shadow Chart is Complete and Accurate
11/05/2008 ---CRA Presenting Consent
09/26/2005 ---CRAs
05/31/2012 ---CRC Staffing
05/10/2010 ---CRF - Patient Access Question
07/24/2008 ---CRF 312.61 Definition question
03/12/2010 ---CRF and DCF
08/04/2010 ---CRF Approval/Notification
09/16/2008 ---CRF as a Source Document
07/05/2007 ---CRF as Source Document
08/09/2010 ---CRF as Source Documents
10/01/2008 ---CRF as the Source
03/14/2007 ---CRF Corrections
09/25/2014 ---CRF Data with No Source Documentation
02/27/2008 ---CRF Query
03/22/2007 ---CRFs
09/16/2008 ---CRFs
02/14/2011 ---CRFs
08/03/2007 ---CRFs- Source Docs
08/03/2007 ---CRFs- SourceDocs-Record Keeping
11/03/2013 ---CRFs and Clinical Investigator Signature
06/06/2008 ---CRFs As Source Documents
09/22/2008 ---CRFs As Source Documents
08/19/2009 ---CRF Signature Page
09/06/2006 ---CRF Signatures
08/08/2003 ---CRFs in the Regulatory Binder
08/15/2004 ---CRFs that have direct entry data with original ink copy collected and sent to sponsor
06/30/2008 ---CRFs to be Used...Not Your Usual CRF
08/29/2002 ---Criteria for enrolling prisoners
04/25/2014 ---Criteria for Entering Country or Nationality Information
09/28/2005 ---CRO
09/06/2012 ---CRO
09/05/2003 ---CRO's
04/29/2010 ---CRO - Remote Monitoring Standards for CRAs?
11/15/2007 ---CRO and Phase I Monitoring
07/18/2006 ---CRO Audits of Clinical Trials Sites
04/03/2007 ---CRO Changed Address
04/19/2010 ---CRO Closure
06/23/2016 ---CRO CRA as Data Entry Person
07/26/2016 ---CRO Obligations for Archiving Sponsors TMF
07/25/2003 ---CRO Programs
11/13/2013 ---CRO Questions to FDA1572 Update and FDA Electronic Signature Certification Letter
12/15/2010 ---CRO Responsibilities
03/01/2013 ---CRO Responsibilities
05/29/2008 ---CROs and IRBs
12/23/2009 ---CRO Services Cover Monitor and Study Coordinator for the Same Project
12/08/2005 ---CRO SOPs
07/27/2011 ---CRO SOPs
01/01/2006 ---Cross Border IRB Review
06/07/2010 ---CRO Transfer of Obligations
07/08/2014 ---Crowd Funding for Research under IND
02/24/2011 ---CSR Appendix 16.1.4 List of Investigators
10/25/2006 ---CSR Appendix Question - Investigator Listing
01/20/2014 ---CT.gov Secondary Outcomes
12/28/2010 ---CTEP's Version of FDA Form 1572
01/10/2010 ---CTEP-Form FDA 1572
11/19/2008 ---CTMA or MOU for an IND Clinical Trial
07/28/2011 ---CTMS Inquiry
02/13/2006 ---CT PET Scan
03/17/2014 ---CTTI Informed Consent Project - Question not directly Associated with Project
04/07/2008 ---Cultural Differences Regarding Signature on IC
07/25/2010 ---Cumulative Clinical Investigator Inspection Lists
07/21/2006 ---Current CFR Part 11 regulations
06/24/2014 ---Current CVs
07/06/2009 ---Current Draft Guidance for the Form FDA 1572 and Device Statement of Investigator
01/13/2011 ---Current FDA-1572 Form
08/11/2002 ---Current FDA 1572 Form
04/05/2006 ---Current Status of Docket No. 2004N-0018
06/17/2009 ---Current Web Edition of FDA Form 1572 Expired May 31, 2009
07/30/2009 ---Current Web Edition of the FDA 1572
03/19/2009 ---Curriculum Vitae Question
03/03/2008 ---Curriculum Vitas
10/19/2015 ---Customer Trial/Beta Test
08/07/2008 ---CV's and 1572's
04/13/2004 ---CV's in clinical trials
11/30/2010 ---CVs for Offsite Co-Investigators
03/31/2011 ---CVs for Sub-Investigators
07/10/2015 ---CVs of the Trial Site Staff Members Listed on the Delegation Log
02/26/2008 ---Daily Life-Minimal Risk
05/31/2005 ---Dangerous Goods Certification
01/07/2005 ---Data and Safety Monitoring
05/15/2015 ---Data and Safety Monitoring
04/24/2008 ---Database
09/23/2015 ---Database Inquiry
08/05/2010 ---Database Lock
10/21/2003 ---Database that is GCP compliant
02/22/2010 ---Database Vendor 812 Responsibilities
04/21/2008 ---Data Clarification Forms After Closure of Trial
04/11/2005 ---Data collection
11/27/2012 ---Data Collection Post Study Closure in Absence of PI
04/27/2011 ---Data Element Traceability in Clinical Trials
12/03/2015 ---Data Entry Question
04/04/2005 ---Data Errors in Clinical Trials
05/29/2013 ---Data Handling for Erroneous Samples/no ICF
09/24/2010 ---Data Management
02/05/2008 ---Data Management - Data Clarification Form
12/23/2008 ---Data Management Question
12/08/2005 ---Data Management Regulations
12/19/2011 ---Data Mgt Question
07/31/2006 ---Data on Study Partners and Neonates- Informed Consent
08/28/2014 ---Data Protection in Clinical Trials Enquiry
02/13/2009 ---Data Query Responses vs Source Docs
02/20/2003 ---Data Safety Monitoring Boards
10/31/2007 ---Data Standardization for Clinical Trials
10/23/2007 ---Data Standardization for Clinical Trials -Solution-1
07/18/2005 ---Data Transcription and the 1572
10/29/2009 ---Data Used After Patient Withdraws ICF
03/13/2012 ---Data Verification after Closure of IRB Review
10/15/2008 ---Date of Study Enrollment
12/09/2010 ---Dates on Consent Forms
04/26/2016 ---Date Stamp Legally Accepted?
10/02/2009 ---Date Stamps
11/18/2008 ---Date Stamps-For CIs
11/30/2007 ---Dating All Signatures
02/23/2012 ---Dating Clinical Trial Documents
09/11/2013 ---Dating of Documents-Guidance
05/19/2016 ---Dating Signatures on PEs
05/19/2016 ---Dating Signatures on PEs
05/02/2011 ---Day 0 for 7-day and 15-day safety reports
06/23/2006 ---DCF Articulated
06/26/2009 ---DDI - CFR 56.108
05/07/2009 ---DDI - CRO Moving Location and Inspections
06/12/2009 ---DDI Questions on Essential Documents (FDA1572 CV)
10/06/2009 ---DDI Revised Informed Consent Inquiry
10/03/2006 ---DEA Requirements
12/02/2002 ---Death Reports
12/12/2013 ---Dec 2013 Resend Question re Toth Allen Presentation
06/30/2004 ---Decedent Rights
11/10/2005 ---December GCP Workshop
08/30/2016 ---Deception in Description of Randomization Procedure
02/20/2003 ---Declaration of Helsinki
05/21/2003 ---Declaration of Helsinki
03/01/2004 ---Declaration of Helsinki
02/24/2005 ---Declaration of Helsinki
02/22/2006 ---Declaration of Helsinki
07/31/2006 ---Declaration of Helsinki
12/29/2009 ---Declaration of Helsinki
08/30/2014 ---Declaration of Helsinki
07/17/2009 ---Declaration of Helsinki and GCP
10/26/2012 ---Declaration of Helsinki in US Contracts
01/10/2007 ---Declaration of Helsinki Version
06/07/2016 ---Deducting from Subject Stipend
12/07/2009 ---Deficiencies Data
01/19/2013 ---Defining "Applicable Clinical Trial"
11/02/2004 ---Defining 'Promotion'
04/22/2002 ---Definition
03/19/2009 ---Definition-Agency
01/06/2009 ---Definition- Applicable Clinical Trial Under FDA AA
01/29/2003 ---Definition Caucasian Subjects
02/22/2010 ---Definition of "Adverse Event"
06/02/2012 ---Definition of "Data"
09/06/2011 ---Definition of "For Cause" Inspection
07/16/2013 ---Definition of a Double-Blind Study
04/19/2004 ---Definition of Central Laboratory
10/12/2007 ---Definition of Clinical Director
07/20/2011 ---Definition of Clinical Trial
04/16/2014 ---Definition of Clinical Trials
11/15/2005 ---Definition of Inpatient Hospitalization
11/16/2009 ---Definition of Inpatient Hospitalization
03/19/2009 ---Definition of Non-Compliance
08/20/2012 ---Definition of Patient Contact
12/11/2006 ---Definition of Satellite Site
03/06/2009 ---Definition of Study Phases
07/03/2012 ---Definition of Sub Investigator in FDA study
05/21/2008 ---Definition of Substantial Evidence
03/20/2003 ---Definitions
05/23/2008 ---Definitions of Various Clinical Trial Dates
11/20/2007 ---Delegation
02/03/2010 ---Delegation Log
06/13/2012 ---Delegation Log Corrections
02/10/2016 ---Delegation Log Question
04/20/2012 ---Delegation Logs
09/04/2013 ---Delegation Logs
08/16/2011 ---Delegation Logs - Internal QA monitors and
06/08/2010 ---Delegation Logs and updates
10/15/2015 ---Delegation of Authority
09/09/2016 ---Delegation of Authority - Assessment, Grading, and Attribution of AEs
03/30/2010 ---Delegation of Authority for Clinical Study Physical Exams, ECG Interpretations and Lab Work Interpretations
06/10/2008 ---Delegation of Authority Form
04/01/2015 ---Delegation of Authority for Prescribing/Ordering Investigational Product
04/01/2015 ---Delegation of Authority for Prescribing/Ordering Investigational Product
08/11/2010 ---Delegation of Authority Log
11/29/2011 ---Delegation of Authority Log
12/03/2014 ---Delegation of Authority Log
05/08/2007 ---Delegation of Authority Logs
05/25/2010 ---Delegation of Authority Logs and Addition to the Protocol
04/28/2009 ---Delegation of Clinical Trial Activities
07/28/2011 ---Delegation of Duties List Question
07/13/2011 ---Delegation of Investigator Responsibilities
06/05/2012 ---Delegation of Medical Decisions and Patient Care to a Licensed Nurse Practitioner
09/14/2006 ---Delegation of Responsibility
10/21/2015 ---Delegation of Safety/Determining Severity/Causality
11/05/2010 ---Delegation of Tasks
07/13/2012 ---Delegation Question
06/20/2008 ---Delegation to Staff
11/18/2008 ---Delegation to SubI- For 6 Months
07/27/2010 ---Demographics CRF
08/19/2014 ---De Novo Petitions and clinicaltrials.gov
11/24/2009 ---Dentist Licenses
06/03/2014 ---Deodorant
09/26/2012 ---Dermatologic Clinical Trial Information
09/27/2012 ---Dermatologic Clinical Trial Information
09/10/2007 ---Description of Study Cohorts in Informed Consent
09/12/2007 ---Designation of Principal Investigators of Clinical Trials Conducted Under Sponsor-Investigator IND or IDE Applications
05/23/2013 ---Destroyed Source Data due to Fire
06/09/2008 ---Destroying Investigational Drugs
07/20/2011 ---Destruction of Clinical Trial Source Documents
09/09/2008 ---Destruction of Source Documents 2 Years Instead of 3 Years After the Study Ended
11/04/2015 ---Destruction of Study Drug
02/05/2016 ---Determination of 'Drug Subject to Section 505 of FD&C Act'
06/17/2010 ---Deviation or Violation
06/16/2009 ---Deviations
10/01/2009 ---Deviations vs. Violations
04/28/2008 ---Deviation Versus Violation
07/19/2013 ---Device
01/19/2007 ---Device GCP Question Regarding Deviations
03/02/2012 ---Device Questions
09/21/2012 ---Device Questions
04/12/2007 ---Device Regulations
09/25/2014 ---Devices Exempt from IDE Regulations
10/17/2012 ---Device Study (Statement of Investigator)
03/19/2009 ---Device Study Question Regarding Sub-Investigators
08/12/2014 ---Device Study Requirements
09/06/2012 ---Device Technicians in Clinical Trials
07/31/2008 ---Device Under IND SR NSR Determination
10/26/2010 ---DHR requirement
10/26/2010 ---DHR requirement
06/23/2013 ---Diabetic Clinicals?
12/13/2011 ---Diagnostic testing clinical trials
11/20/2013 ---Dialysis Facility Site for a Clinical Trial
09/12/2002 ---Diaries as Source Documents
04/01/2015 ---Dietary Supplement Finished Product
06/06/2008 ---Diets for Bioeq Studies
11/04/2014 ---Difference between GCP/ICH and only ICH Guidelines
09/13/2004 ---Difference between ICH GCP and FDA Regulations
10/29/2014 ---Difference between IRB and IEC
04/24/2008 ---Difference Between NIH and FDA
01/05/2011 ---Difference between Sub Investigator and Co Investigator
08/29/2007 ---Difference EU USFDA Clinical Research Unit
12/28/2007 ---Differences Between GCP and GLP
08/27/2010 ---Differences in FDA and ICH GCP
05/09/2004 ---Differences in FDA requirement for a DSMB and DHHS requirements
04/23/2008 ---Differences to Monitor Data from Vaccine and Pharma Studies
01/24/2013 ---Digital Clinical Trial Documents
02/19/2010 ---Dilemma Question
10/08/2008 ---Direct Contact of Monitors with Subjects
03/31/2009 ---Direct Mail Good Clinical Practice Regulatory Information
04/12/2007 ---Dis-enrolling Patients
10/02/2007 ---Disclosing 483s
12/10/2010 ---Disclosure
03/30/2011 ---Disclosure: Financial Interest and Arrangements of Clinical Investigators
06/14/2013 ---Discontinuance of Clinical Trial Site
06/14/2013 ---Discontinuance of Clinical Trial Site
02/27/2010 ---Discontinuation of Clinical Research Program
10/08/2008 ---Discontinuing Study Drug-Subject Eligibility
04/04/2008 ---Discrepancy Between HIPAA and HHS Regulations and FDA Non-Allowance of Waiver of Consent
05/08/2014 ---Discrepancy of Self-Report vs. Source Documents
11/07/2007 ---Dispense vs. Administer
09/24/2010 ---Dispensing Investigational Products
04/15/2008 ---Dispensing of Investigational Drugs in a Clinical Trial
05/03/2010 ---Dispensing of Study Drugs
04/30/2007 ---Disposing of Expired Pharmaceutical Samples
08/27/2009 ---Disposition of Clinical Study Records
03/17/2011 ---Dissertation EMA - FDA
03/29/2011 ---Dissertation EMA-FDA
04/04/2011 ---Dissertation EMA-FDA
04/12/2011 ---Dissertation EMA-FDA
03/16/2011 ---Dissertation EMA/FDA
03/29/2010 ---Dissolution of Research Clinic
03/26/2010 ---Distinction between a Protocol Violation and a Protocol Deviation
02/13/2007 ---DMC Members
09/06/2007 ---DMCs CVs Email Records
11/14/2012 ---Do CFR and PROs Require EC Approval
01/09/2004 ---Do CGMPs apply to clinical trial materials?
03/09/2004 ---Docket No. 01N-0322 - NPRM on Sponsors Informing IRBs of Any Prior IRB Reviews
11/12/2009 ---Doctorate Approval
03/03/2011 ---Documentation
01/24/2011 ---Documentation about Consent
05/29/2015 ---Documentation for Off-Site Radiology
05/08/2008 ---Documentation Grade of Preliminary Products for an Application for Approval
05/09/2008 ---Documentation Grade of Preliminary Products for Application for Approval
09/22/2008 ---Documentation of a Study Subject's Prior Medical History
09/24/2010 ---Documentation of Clinical Trial Informed Consent Discussion- Required Elements
09/12/2014 ---Documentation of Communication between PI and Study Team
09/22/2014 ---Documentation of Communication between PI and Study Team
08/30/2012 ---Documentation of Eligibility Criteria
06/16/2011 ---Documentation of Informed Consent in Subjects' Case Histories/Statement by PI of IC Eligibility
02/05/2009 ---Documentation of Informed Consent of the Visually Impaired
04/27/2012 ---Documentation of Monitoring Visits/Questions about Monitoring Report Finalization
03/13/2006 ---Documentation of Qualifications
10/24/2004 ---Documentation of Site Communications via Telephone Contact Reports
08/30/2004 ---Documentation of the ICF Process
07/23/2013 ---Documentation of Training
03/26/2012 ---Documentation of Withdrawal from Study
10/06/2009 ---Documentation Question
02/05/2007 ---Documentation Retention
03/03/2011 ---Documentation Retention
08/05/2008 ---Documentation Storage Guidelines
01/21/2011 ---Documentation to be Provided to CI for Reference Drug - ISF
10/24/2012 ---Document GCP Training
08/23/2011 ---Documenting Category of Expedited Review
04/23/2008 ---Documenting Consent in the Subject's Records
03/19/2009 ---Documenting Informed Consent
12/13/2012 ---Documenting Sub-Investigators on Medical Device Statement of Investigators
03/19/2008 ---Document Retention
03/06/2012 ---Document Retention
04/29/2011 ---Documents received from Sites
03/19/2010 ---Documents Signed During an Inspection
04/04/2015 ---Documents that the FDA Inspector is Allowed to Inspect
07/14/2008 ---Document Storage
03/10/2008 ---Do CVs Have to be Signed?
02/03/2009 ---Does a Form FDA 1572 Have to Be Completed When Subjects are Consented to a Trial?
08/14/2015 ---Does an Observational Data Collection Study meet the Definition of a Clinical Investigation?
12/15/2006 ---Does Discarding Non-Compliant Data Constitute "Compliance"?
09/12/2014 ---Does eTMF Need to Comply with 21 CFR Part 11
03/02/2006 ---Does FDA Have to be Named?
04/03/2013 ---Does FDA require CVs be Dated and Signed every Two Years?
09/25/2008 ---Does FDA Sponsor Clinical Trials
01/23/2004 ---Does GCPP Review Books and Articles for the Public
10/02/2006 ---Does Hospital Need to be on 1572?
12/13/2012 ---Does ICH-GCP E6 Require IRB Review of Subject Intake Forms as "Written Information to be Provided to Subjects"
04/27/2005 ---Does Part 54 Apply to CI Initiated Studies
05/09/2006 ---Does Phase Affect AE Reporting?
04/25/2013 ---Does PMA Submission Count for Final Report
04/01/2013 ---Does PMA Submission Meet Requirement to Send Final Report within Six Months per 21 CFR 812.150 (b)(7)
08/19/2014 ---Does this Consent Comply with FDA Disclosure Requirements?
02/10/2013 ---Does this Guidance apply to IRBs?
02/27/2008 ---Do GLP Regs Apply to Clin Analyses
02/06/2009 ---Do IND-IRB Approvals Need To Be In a Particular Order
09/15/2008 ---Do I Need FDA Approval
08/27/2016 ---Do I Need to Register? High-Level Description of Research Provided
08/14/2008 ---Do IRBs Need To Review Dosing Worksheets
09/03/2008 ---Do Licenses Have to be Updated
02/14/2015 ---Do NIH Funded Studies Observe FDA Regulations and Should they Follow ICH-GCP Guidelines
04/21/2009 ---Door to Study Record Area
12/27/2006 ---Dose Administration
08/22/2007 ---Double Billing for Study Procedures
04/01/2010 ---Double Blinding for a Trial
05/23/2006 ---Double Data Entry
05/14/2013 ---Double Enrollment of Participant into a Clinical Trial
12/11/2009 ---Doubt About Patient Records
11/05/2009 ---Doubt Regarding ICF Update
09/20/2005 ---A Doubt Regarding ICH-GCP
12/01/2010 ---Doubt Regarding Results of FDA Audit at Clinical Research Site
10/29/2004 ---Doubt Regarding the Informed Consent form
12/01/2014 ---Doubts about GCP
10/13/2010 ---Doubts regarding Deactivation of IRB
04/10/2008 ---Doubts Regarding Investigator's Responsibilities
05/11/2015 ---Do We Need to Register with ClinicalTrials.gov?
05/24/2010 ---Downgraded AE Reporting
05/24/2010 ---Downgraded AE rReporting
01/07/2010 ---Draft Guidance
11/17/2006 ---Draft Guidance- Emergency Research
12/19/2012 ---Draft Guidance Concerning Clinical Trials
09/04/2009 ---Draft Guidance for FDA 1572
07/23/2014 ---Draft Guidance on Updated Informed Consent
02/28/2013 ---Draft Guidances Publications
07/18/2014 ---Draft Informed Consent Document
10/22/2014 ---Draft Informed Consent Guidance
10/07/2015 ---Draft or Unused Versions of 1572s in Investigator Site File
11/29/2011 ---Draft Questions to Send to FDA
10/27/2006 ---Drug + Biomarker
12/17/2003 ---Drug accountability
08/03/2007 ---Drug Accountability
01/10/2008 ---Drug Accountability
05/01/2008 ---Drug Accountability
12/08/2009 ---Drug Accountability
06/19/2013 ---Drug Accountability
07/17/2013 ---Drug Accountability at Clinical Sites
09/29/2008 ---Drug Accountability Records
12/14/2009 ---Drug Accountability Records
05/12/2008 ---Drug Accountability Subject Withdrawal
02/03/2012 ---Drug Administration by Research Nurses
12/15/2009 ---Drug Approval
04/11/2003 ---Drug Clinical Testing
07/05/2010 ---Drug Development
03/29/2005 ---Drug Dispensing and Dosing of Subjects
01/30/2008 ---Drug Export Question
04/21/2010 ---Drug Info Comment Form FDA/CDER Site
10/20/2010 ---Drug Info Comment Form FDA/CDER Site
04/14/2011 ---Drug Info Comment Form FDA/CDER Site
04/21/2011 ---Drug Info Comment Form FDA/CDER Site
04/27/2011 ---Drug Info Comment Form FDA/CDER Site
02/04/2004 ---DrugInfo Comment Form FDA/CDER Site
02/06/2004 ---DrugInfo Comment Form FDA/CDER Site
02/06/2004 ---DrugInfo Comment Form FDA/CDER Site
02/11/2004 ---DrugInfo Comment Form FDA/CDER Site
02/11/2004 ---DrugInfo Comment Form FDA/CDER Site
02/26/2004 ---DrugInfo Comment Form FDA/CDER Site
03/02/2004 ---DrugInfo Comment Form FDA/CDER Site
04/21/2004 ---DrugInfo Comment Form FDA/CDER Site
05/11/2004 ---DrugInfo Comment Form FDA/CDER Site
05/21/2004 ---DrugInfo Comment Form FDA/CDER Site
05/27/2004 ---DrugInfo Comment Form FDA/CDER Site
06/25/2004 ---DrugInfo Comment Form FDA/CDER Site
07/13/2004 ---DrugInfo Comment Form FDA/CDER Site
08/06/2004 ---DrugInfo Comment Form FDA/CDER Site
08/06/2004 ---DrugInfo Comment Form FDA/CDER Site
08/06/2004 ---DrugInfo Comment Form FDA/CDER Site
08/30/2004 ---DrugInfo Comment Form FDA/CDER Site
08/30/2004 ---DrugInfo Comment Form FDA/CDER Site
08/30/2004 ---DrugInfo Comment Form FDA/CDER Site
08/30/2004 ---DrugInfo Comment Form FDA/CDER Site
09/07/2004 ---DrugInfo Comment Form FDA/CDER Site
09/07/2004 ---DrugInfo Comment Form FDA/CDER Site
09/07/2004 ---DrugInfo Comment Form FDA/CDER Site
10/05/2004 ---DrugInfo Comment Form FDA/CDER Site
10/08/2004 ---DrugInfo Comment Form FDA/CDER Site
10/26/2004 ---DrugInfo Comment Form FDA/CDER Site
10/26/2004 ---DrugInfo Comment Form FDA/CDER Site
11/01/2004 ---DrugInfo Comment Form FDA/CDER Site
11/12/2004 ---DrugInfo Comment Form FDA/CDER Site
11/15/2004 ---DrugInfo Comment Form FDA/CDER Site
11/23/2004 ---DrugInfo Comment Form FDA/CDER Site
11/30/2004 ---DrugInfo Comment Form FDA/CDER Site
11/30/2004 ---DrugInfo Comment Form FDA/CDER Site
12/01/2004 ---DrugInfo Comment Form FDA/CDER Site
12/09/2004 ---DrugInfo Comment Form FDA/CDER Site
12/10/2004 ---DrugInfo Comment Form FDA/CDER Site
12/17/2004 ---DrugInfo Comment Form FDA/CDER Site
01/26/2005 ---DrugInfo Comment Form FDA/CDER Site
02/01/2005 ---DrugInfo Comment Form FDA/CDER Site
02/03/2005 ---DrugInfo Comment Form FDA/CDER Site
02/22/2005 ---DrugInfo Comment Form FDA/CDER Site
02/23/2005 ---DrugInfo Comment Form FDA/CDER Site
03/29/2005 ---DrugInfo Comment Form FDA/CDER Site
03/29/2005 ---DrugInfo Comment Form FDA/CDER Site
04/07/2005 ---DrugInfo Comment Form FDA/CDER Site
04/11/2005 ---DrugInfo Comment Form FDA/CDER Site
05/11/2005 ---DrugInfo Comment Form FDA/CDER Site
05/18/2005 ---DrugInfo Comment Form FDA/CDER Site
05/31/2005 ---DrugInfo Comment Form FDA/CDER Site
05/31/2005 ---DrugInfo Comment Form FDA/CDER Site
06/02/2005 ---DrugInfo Comment Form FDA/CDER Site
06/20/2005 ---DrugInfo Comment Form FDA/CDER Site
07/12/2005 ---DrugInfo Comment Form FDA/CDER Site
07/26/2005 ---DrugInfo Comment Form FDA/CDER Site
07/26/2005 ---DrugInfo Comment Form FDA/CDER Site
08/09/2005 ---DrugInfo Comment Form FDA/CDER Site
08/11/2005 ---DrugInfo Comment Form FDA/CDER Site
09/06/2005 ---DrugInfo Comment Form FDA/CDER Site
10/03/2005 ---DrugInfo Comment Form FDA/CDER Site
11/10/2005 ---DrugInfo Comment Form FDA/CDER Site
11/22/2005 ---DrugInfo Comment Form FDA/CDER Site
12/16/2005 ---DrugInfo Comment Form FDA/CDER Site
01/18/2006 ---DrugInfo Comment Form FDA/CDER Site
03/07/2006 ---DrugInfo Comment Form FDA/CDER Site
11/24/2006 ---DrugInfo Comment Form FDA/CDER Site
06/27/2007 ---DrugInfo Comment Form FDA/CDER Site
07/11/2007 ---DrugInfo Comment Form FDA/CDER Site
07/24/2008 ---DrugInfo Comment Form FDA/CDER Site
10/14/2008 ---DrugInfo Comment Form FDA/CDER Site
10/22/2008 ---DrugInfo Comment Form FDA/CDER Site
02/19/2010 ---DrugInfo Comment Form FDA/CDER Site
08/03/2010 ---DrugInfo Comment Form FDA/CDER Site
01/27/2011 ---DrugInfo Comment Form FDA/CDER Site
04/21/2011 ---DrugInfo Comment Form FDA/CDER Site
06/02/2011 ---DrugInfo Comment Form FDA/CDER Site
02/21/2013 ---DrugInfo Comment Form FDA/CDER Site
07/28/2005 ---DrugInfo Comment Form FDA/CDER Site - Further Inquiry
10/27/2005 ---DrugInfo Comment Form FDA/CDER Site 10/27/05
10/27/2004 ---DrugInfo Comment Form FDA/CIDER Site
04/17/2008 ---Drug Info Comment Form FDACDER Site
12/01/2008 ---Drug Info Comment Form FDACDER Site
04/28/2008 ---DrugInfo Comment Form FDACDER Site
08/05/2008 ---DrugInfo Comment Form FDACDER Site
08/12/2009 ---Drug Information Comment Form FDA CDER Site
03/11/2010 ---Druglnfo Comment Form FDA/CDER Site
05/01/2011 ---Drug Name
10/06/2008 ---Drugs for Alzheimer's
04/15/2008 ---Drugs in the Pipeline for Infertility
08/28/2008 ---Drug Study Design Controls
03/25/2002 ---Drug study paper
03/25/2009 ---Drug Testing
08/29/2011 ---Drug Transfers
10/12/2010 ---Drug Trial Question
02/19/2004 ---DSMB
10/30/2007 ---DSMB and CEC Dual Membership
02/20/2003 ---DSMBs for industry sponsored studies
12/19/2011 ---DSMC Temporary Suspension
12/19/2011 ---DSMC Temporary Suspension
06/13/2012 ---Dual Enrollment Question
04/06/2009 ---Due Diligence
05/29/2007 ---Due Diligence Document
07/11/2002 ---due diligence in reviewing patients' medical history
09/13/2006 ---Dupuytren's Contracture
06/30/2004 ---Duration of Study Specificity
10/25/2006 ---E-mails and Faxes
02/13/2007 ---E-Record Use at Investigator Site
02/02/2016 ---E-signature
12/05/2016 ---E-signatures, eICF
12/11/2012 ---E-signatures and Clinical Research
06/29/2016 ---E-source Question
05/03/2002 ---E-trial requirements
04/02/2003 ---E6 GCP
02/06/2007 ---Early Intervention Program Beyond CDRH
07/22/2010 ---EC/RA Notification of Rejected Protocol
02/20/2011 ---EC Dissolution
06/29/2011 ---EC Minutes Review by Sponsor CRO
06/18/2014 ---Econsent and Email In Lieu of Print
06/03/2013 ---ECRF as Source
04/17/2006 ---ECs on the 1572
04/24/2011 ---EC Submission by Sponsor CRO
06/19/2007 ---EDC and Screening Logs
06/25/2010 ---EDC Lab Data Question
11/15/2010 ---EDC Privacy Rules
12/31/2007 ---Educational Courses
07/02/2004 ---Education Materials
12/22/2004 ---Education requirements for IRB members
12/22/2004 ---Education Requirements for IRB Members
11/27/2013 ---Effective Date of Clinical Trial Agreement
02/19/2009 ---Effect of Study Design on Minimal Risk Determination
12/12/2005 ---Efficacy Evaluation During Clinical Trials
07/27/2007 ---Eight Questions
08/14/2015 ---EIR
08/14/2015 ---EIR
04/04/2011 ---EIRs and 483s
10/28/2014 ---EKG
02/18/2005 ---Electronic approvals/correspondence
08/11/2009 ---Electronic Archiving
07/20/2013 ---Electronic Clinical Chart vs 21 CRF Part 11
05/07/2008 ---Electronic Communication
04/10/2002 ---Electronic correspondence
05/09/2002 ---Electronic Data
06/10/2011 ---Electronic Data Capture
11/22/2011 ---Electronic Data Capture (EDC) query
07/30/2002 ---Electronic Data Capture-Quality of Life Scope
04/02/2007 ---Electronic Data Capture of SAEs
03/24/2016 ---Electronic DOA Logs
01/23/2014 ---Electronic Document Management System
02/28/2012 ---Electronic Essential Documents
03/15/2006 ---Electronic Files
04/16/2013 ---Electronic Filing Question
03/29/2005 ---Electronic Medical Record
01/09/2013 ---Electronic Medical Records
10/28/2013 ---Electronic Medical Records & SDV
06/15/2007 ---Electronic Medical Records Across Many Clinics
11/02/2015 ---Electronic Medical Records Availability
04/01/2003 ---Electronic medical records for clinical studies
02/11/2015 ---Electronic Medical Records Source & Certified Copies
02/11/2010 ---Electronic Medical Record System Question
12/18/2013 ---Electronic Print out of Medical Records and Certified Copies
10/25/2002 ---Electronic records
06/26/2003 ---Electronic records
06/02/2005 ---Electronic records
04/20/2016 ---Electronic Records
07/10/2014 ---Electronic Records; Electronic Signatures (21 CFR Part 11)
06/21/2013 ---Electronic Records and Hard Copies
11/15/2012 ---Electronic Records in Research
01/28/2008 ---Electronic Records Question
07/02/2002 ---Electronic record storage
11/21/2012 ---Electronic Signature and Part 11 Compliance
11/17/2015 ---Electronic Signature Certification
02/28/2006 ---Electronic Signature on a Group of Pages
10/28/2005 ---Electronic signatures
06/19/2006 ---Electronic Signatures
11/20/2006 ---Electronic Signatures
02/06/2012 ---Electronic Signatures
12/09/2013 ---Electronic Signatures
11/01/2012 ---Electronic Signatures - Clinical Investigator Contracts
11/01/2012 ---Electronic Signatures - Clinical Investigator Contracts Followup
05/19/2015 ---Electronic Signatures and Wet Ink Signatures on Same Document
02/26/2012 ---Electronic Signatures on Contracts, Training Forms, etc.
07/12/2016 ---Electronic Signatures on Essential Study Documents
03/03/2014 ---Electronic Signatures Vs No Signatures
09/13/2006 ---Electronic Source Document
08/12/2008 ---Electronic Source Documentation for Clinical Trials
06/02/2011 ---Electronic Source Documentation in Clinical Investigations - Draft Guidance December, 2010
06/08/2009 ---Electronic Source Documents Question
08/10/2009 ---Electronic Source Documents Question
03/27/2007 ---Electronic Source Document Use at Investigator Site
05/05/2008 ---Electronic System Use with No Allowance to View E-Data
04/19/2005 ---Electronic TMF
10/01/2014 ---Electronic Training Records
08/03/2015 ---Eligibility
08/15/2011 ---Eligibility Checklists
04/07/2011 ---Eligibility Documentation
12/02/2011 ---Eligibility of Subjects that have Previously Participated in Other Trial
05/06/2011 ---Eligible Criteria for Paid Clinical Trials
10/27/2014 ---Email for Questions to the FDA
04/29/2013 ---Emailing ICF
08/16/2004 ---Emailing Index
02/05/2013 ---Emailing Research Documents
10/28/2008 ---Emergency Exception and Risk Assessment for Surgical Clinical Trials
05/17/2007 ---Emergency Exception to Informed Consent Draft Guidance
12/11/2008 ---Emergency Medicine Research EFIC
10/12/2007 ---Emergency Research
02/07/2007 ---Emergency Research - Question
04/26/2012 ---Emergency Unblinding Question
06/25/2009 ---Emergency Use 5 Day Report
08/07/2009 ---Emergency Use of a Test Article
08/11/2009 ---Emergency Use of a Test Article-2
04/19/2004 ---Emergency Use of Investigational Drug
02/07/2012 ---Emergent Use question
05/16/2008 ---EMR
03/18/2014 ---EMR
07/05/2016 ---EMR Access
06/30/2012 ---EMR and Clinical Trials
07/09/2010 ---Encryption of Clinical Trial Records Vs Accessibility
08/31/2004 ---End Date of Subjs Participation
12/04/2012 ---End of Trial
07/29/2013 ---Engaged in Clinical Investigation????
05/19/2008 ---Engaged in Human Subject Study
05/27/2015 ---Engaged in Research Question
03/09/2005 ---English Translations in Foreign Clinical Sites
01/03/2006 ---ENQUIRE
10/25/2013 ---Enquiry
01/16/2014 ---Enquiry
06/02/2015 ---Enquiry
02/14/2011 ---Enquiry: Correct use of FDA1572
09/22/2011 ---Enquiry about ICF process
02/27/2013 ---Enquiry about Storage of Human Tissue Samples and or Derived Data Files
04/27/2010 ---Enquiry on GCP Requirements of Investigator
09/16/2010 ---Enquiry on the Clinical Trials
06/28/2011 ---Enrolled, Randomised or Signature of ICF-Permitted before Signed Clinical Trial Agreement
09/19/2006 ---Enrolling Clinical Trial Staff
08/29/2014 ---Enrolling Prisoners
05/08/2009 ---Enrolling Prisoners in Clinical Trial
05/16/2013 ---Enrollment
05/12/2005 ---Enrollment Incentives
02/03/2005 ---Enrollment in Competing Studies
02/27/2006 ---Enrollment of Self-Family
06/02/2015 ---Ensuring Compliance with 21 CFR Part 211.1
07/15/2015 ---Entries to eCRFs by the Study Monitor and EMR Printed Copies Certification
03/16/2009 ---Entry CI Questions
09/16/2011 ---Erythropoiesis Stimulating Agents
02/16/2016 ---eSignatures on 1572
12/27/2012 ---Essential/Regulatory Document Filing
10/31/2011 ---Essential Documents
07/17/2015 ---Essential Documents
08/02/2006 ---Essential Documents and Providers of Centralized
06/27/2003 ---Essential Documents Question
10/21/2010 ---Essential Documents Retention Related Queries
06/15/2011 ---Establishing an IRB
03/05/2003 ---Establishment of DSMB
02/01/2013 ---Ethical Approval Enquiry
02/04/2013 ---Ethical Approval Enquiry
11/14/2016 ---Ethical Concern of the Compensation of Travel Cost in Clinical Studies.
10/28/2002 ---Ethical question
09/08/2011 ---An Ethical Question Regarding Patients Being Approached for a Clinical Trial
08/15/2007 ---Ethics-India
08/01/2006 ---Ethics and Clinical Trials
11/29/2012 ---Ethics Committee Approval Letter Query
11/29/2012 ---Ethics Committee Approval Letter Query Study Not Conducted Under an IND
10/13/2010 ---Ethics Committee Clarification
01/18/2013 ---Ethics Committee Quorum Approval
10/18/2013 ---Ethics Committee Related Queries: Kindly Opine on the Same
01/31/2014 ---Ethics Committee Related Queries: Kindly Opine on the Same
02/10/2009 ---Ethnicity
08/13/2014 ---eTMF Questions
08/01/2012 ---eTMFs and Site Investigator Files--Moving Completely to Electronic Documents
11/06/2003 ---EU Investigators and the 1572
03/27/2008 ---EU SUSAR and FDA IND-SR
02/05/2009 ---Evaluation Neonatal Hypoglycemia in Clinical Trial
09/20/2006 ---Ex-US Approval
05/19/2009 ---Exception from Informed Consent
02/07/2007 ---Exception from Informed Consent Requirements for Emergency Research - Question
10/03/2005 ---Exceptions
09/25/2002 ---Exceptions to IC
01/11/2006 ---Exception to Informed Consent (Emergency Settings) Research
04/20/2007 ---Excl-InclCriteria in ICF
04/08/2016 ---Excluding Data from Clinical Trial Analysis
02/09/2012 ---Exclusion from the Definition of ACT: Uncontrolled Clinical Trials
07/16/2015 ---Exculpatory Language
02/26/2015 ---Exculpatory Language Question
12/17/2015 ---Exempt Category 8 (a)
10/29/2013 ---Exemption Explained
03/03/2008 ---Exemption From 312
08/18/2015 ---Exempt IVD Collection Study Question
07/07/2003 ---Exempt research
07/08/2003 ---Exempt research
07/07/2007 ---Exempt research
03/02/2005 ---Exp. vs. Full Continuing IRB Review?
02/08/2008 ---Expanded Access- Is Inf Cons Required
09/22/2010 ---Expanded Access Protocol
11/03/2011 ---Expanded Access Use Program
12/10/2014 ---Expectations of PI On-Site Presence and Oversight
05/18/2011 ---Expedited
03/31/2011 ---Expedited Reporting to IRB Members
03/31/2011 ---Expedited Reporting to IRB Members
04/04/2011 ---Expedited reporting to IRB Members
12/10/2002 ---Expedited Review
08/21/2006 ---Expedited Review
07/09/2007 ---Expedited Review
05/03/2010 ---Expedited Review
12/27/2007 ---Expedited Review (21 CFR 56.110)
11/09/2011 ---Expedited Review - tampons
09/25/2008 ---Expedited Review Category 8
05/10/2010 ---Expedited Review for Adding New Sites
02/04/2009 ---Expedited Review Procedures and More
03/22/2005 ---Expedited review question
04/08/2009 ---Expedited Reviews
07/23/2002 ---Experimental medicine
03/04/2003 ---Expert Systems
04/07/2006 ---Expiration Date
01/06/2006 ---Expiration Date- 1572
03/11/2005 ---Expiration Date for Investigational Drug
10/03/2007 ---Expiration Dates- Consent Forms
05/04/2015 ---Expiration Dates for GCP
08/04/2008 ---Expiration Of Consent Form
04/01/2009 ---Expired 1572
07/20/2010 ---Expired 1572
01/14/2003 ---Expired form 1572
08/04/2009 ---Expired Form FDA 1572
06/01/2015 ---Expired On-line 1572
06/01/2009 ---Expiring Form 1572
09/03/2002 ---Expiring Form FDA 1572
06/09/2010 ---Exploratory Clinical Trials - Category A, Surveillance
07/01/2003 ---Exports for clinical trials
10/06/2011 ---Extended 1.5 yr Absence of PI Acceptable
03/06/2012 ---Extent of IRB Follow Up
09/28/2015 ---Extent of IRB Review
10/10/2003 ---External Adverse Event Reports
06/12/2008 ---External Adverse Events
12/07/2007 ---External Adverse Events Reporting
03/03/2008 ---External AE Reports
12/16/2015 ---External Inquiry on ICH E6
03/24/2015 ---Extra Assessments on visits as Protocol Deviation/Violation
11/20/2003 ---F/U to my 11/5 email
05/14/2007 ---Facilities Providing Standard of Care
05/08/2009 ---Facts About Source Documents- Training
06/20/2003 ---Failure to obtain Informed Consent
08/26/2011 ---Family Members as EC Members
01/10/2011 ---FAQ: Form FDA 1572
05/18/2016 ---Fasting Before a Screening Visit
08/09/2010 ---Fasting for Labs.
09/18/2009 ---Fax Confirmations
04/27/2010 ---Faxed Consent Forms
03/03/2013 ---Faxed Informed Consent Documents
04/04/2003 ---Faxing Consents
05/05/2008 ---Faxing Source Documents
09/28/2011 ---Fax Number Needed
01/23/2013 ---FCPA
10/24/2003 ---FDA
09/14/2016 ---FDA "Enforcement Discretion" and ClinicalTrials.gov
02/11/2005 ---FDA's 1988 Monitoring Guideline
08/15/2011 ---FDA's Guideline for Monitoring Clinical Investigations
02/17/2012 ---FDA's Investigator Responsibilities Training
07/27/2015 ---FDA's Office of Good Clinical Practice
08/11/2014 ---FDA's position on 21 CFR 312.32 IND Safety Reporting - Expected/Unexpected Adverse Event
11/10/2005 ---FDA's Position on the Helsinki Protocols for Clinic Trials
04/29/2014 ---FDA's views on Protocol Documents Required IRB Submission
06/03/2009 ---FDA, Auditor and Monitor to Medical Records
09/18/2013 ---FDA-GCP 1977
12/01/2011 ---FDA-Regulated Trial
06/07/2011 ---FDA - sFDA - GCP Certification in Chinese Investigative Sites
09/18/2013 ---FDA-Standard Clinical Trials
01/06/2006 ---FDA/CDER Site
01/12/2006 ---FDA/CDER Site
01/26/2006 ---FDA/CDER Site
02/21/2006 ---FDA/CDER Site
06/19/2006 ---FDA/CDER Site
07/07/2006 ---FDA/CDER Site
10/18/2006 ---FDA/CDER Site
11/07/2006 ---FDA/CDER Site
11/28/2006 ---FDA/CDER Site
01/30/2009 ---FDA/CDER Site
07/13/2009 ---FDA/CDER Site
04/21/2010 ---FDA/Clinical Studies for [Redacted]
01/25/2011 ---FDA/EMA GCP inspections
05/14/2014 ---FDA/GCP/IRB Question regarding Generic Recruitment Materials for Clinical Research
03/04/2003 ---FDA/HHS Protection of Human Research Subjects
06/08/2016 ---FDA 483 and Re-inspection Question
06/14/2005 ---FDA 483 Warning Letter Questions
03/16/2012 ---FDA 1571
08/20/2002 ---FDA 1572
04/15/2004 ---FDA 1572
06/15/2004 ---FDA 1572
08/19/2005 ---FDA 1572
10/26/2005 ---FDA 1572
01/24/2008 ---FDA 1572
04/11/2008 ---FDA 1572
02/02/2010 ---FDA 1572
02/02/2010 ---FDA 1572
03/26/2010 ---FDA 1572
08/11/2010 ---FDA 1572
11/18/2010 ---FDA 1572
11/18/2013 ---FDA1572 & Financial Disclosure Subinvestigator/Study Nurse who Vaccinate
10/14/2014 ---FDA 1572 - Electronic Signatures
03/05/2014 ---FDA 1572 - Home Visits
12/12/2008 ---FDA 1572 - Investigator Laboratory
08/11/2013 ---FDA1572 - Query
07/09/2010 ---FDA 1572 - Sub-Investigators
09/29/2016 ---FDA1572 / Change of Address of Principal Investigator
08/19/2009 ---FDA 1572 and Financial Disclosure Doubts
11/13/2012 ---FDA 1572 and Subinvestigator
09/15/2015 ---FDA 1572 Block 6
03/30/2012 ---FDA 1572 Clinical Laboratory Inclusion
01/23/2015 ---FDA 1572 Completed by Mexican Investigators
10/10/2016 ---FDA 1572 Completion - Section #6
09/19/2010 ---FDA 1572 Completion Section #5 - IRB Details
03/13/2014 ---FDA 1572 Continuation Page
05/28/2009 ---FDA 1572 Due to Expire May 31, 2009
04/09/2012 ---FDA 1572 Expiration Date
08/27/2004 ---FDA 1572 File
01/03/2012 ---FDA1572 for Foreign Studies
02/21/2006 ---FDA 1572 Form
01/26/2009 ---FDA 1572 Form
11/06/2009 ---FDA 1572 Form
12/25/2010 ---FDA 1572 form
04/06/2015 ---FDA 1572 Form - Original Signed Copies
11/30/2009 ---FDA 1572 Form- Section #3
12/27/2012 ---FDA 1572 Form - Section # 6
04/20/2012 ---FDA 1572 Form: Adding Study Coordinators
05/27/2012 ---FDA 1572 Form: Local Lab Facility Listed in Section 4
02/01/2005 ---FDA 1572 form completion
07/17/2015 ---FDA 1572 Form Section #10
05/30/2008 ---FDA 1572 from Non-US Investigators in Multinational Trials Under and IND
10/17/2016 ---FDA 1572 Hand Written Corrections
12/17/2013 ---FDA 1572 Out of the US Countries
03/05/2008 ---FDA 1572 Question
03/26/2009 ---FDA 1572 Question
03/19/2010 ---FDA 1572 question
02/17/2012 ---FDA 1572 Question
09/14/2015 ---FDA 1572 Question
04/16/2012 ---FDA 1572 Question Clinic Labs
04/08/2011 ---FDA1572 Question not covered in FAQ
07/02/2007 ---FDA 1572 Question RE Protocol Synopsis
02/16/2012 ---FDA 1572 Section 6 Name of Sub-investigator with Typographical Error
04/26/2012 ---FDA1572, 2012 Version
08/19/2010 ---FDA 1572, Expired Forms
02/17/2010 ---FDA 1572, FDF and Responsibility Delegation Log
10/19/2009 ---FDA 1572- Questions Regarding OMB Approval for FDA to Use the Form Until 8-31-2011
03/08/2007 ---FDA 1572- Revised Protocol Title
10/10/2013 ---FDA 1572- To save with already included Site Information
06/07/2014 ---FDA 2004 Draft Guidance, "Guidance for Industry Pharmacokinetics in Pregnancy ― Study Design, Data Analysis, and Impact on Dosing and Labeling"
05/19/2005 ---FDA Acceptance of Pre-Clinical and Clinical Data from India
09/22/2015 ---FDA Access to CAPAs
06/20/2013 ---FDA Access to eTMF
05/21/2014 ---FDA Advice Requested on Impartial Witness
03/16/2016 ---FDA Advice Requested on Impartial Witness - When is an IW Needed
03/23/2016 ---FDA Advice Requested on Maintaining Primary Source/Records Retention at Site
07/25/2012 ---FDA Advocating Clinical Trials Ex-US to Boost Minority Enrollment
11/21/2005 ---FDA and Foreign Clinical Trials
07/24/2009 ---FDA and OHRP Guidance Documents
08/23/2010 ---FDA Approval for Conducting Clinical Studies
08/12/2009 ---FDA Approval for Medical Procedure
06/11/2008 ---FDA Approved
06/26/2008 ---FDA Approved Contract Packager
08/14/2009 ---FDA Approved Sites
11/20/2014 ---FDA Audit
08/14/2013 ---FDA Audit and Guidelines of use of Data for MA from Emerging Regions
08/26/2010 ---FDA Audit Certification
08/23/2013 ---FDA Audit of Clinical Trials
07/22/2009 ---FDA Audit Question
11/12/2009 ---FDA Audit Question
11/13/2009 ---FDA Audit Question-2
08/14/2008 ---FDA Audits
10/25/2010 ---FDA Audits
11/04/2005 ---FDA Audits - India
09/17/2014 ---FDA BIMO
10/14/2004 ---FDA Certification for Clinical Research
10/08/2002 ---FDA CFR21 part 11
02/15/2007 ---FDA Cite Question
01/28/2015 ---FDA Clinical Inspections List
05/18/2012 ---FDA Clinical Investigator Training Course 2012
06/02/2010 ---FDA Clinical Registries Information
04/19/2007 ---FDA Clinical Research Coordinators
04/03/2008 ---FDA Clinical Trial Requirements for Pre-Enrollment Activities
08/20/2002 ---FDA Comments
08/29/2002 ---FDA Comments
09/06/2002 ---FDA Comments
10/02/2002 ---FDA Comments
10/04/2002 ---FDA Comments
10/21/2002 ---FDA Comments
12/10/2002 ---FDA Comments
12/10/2002 ---FDA Comments
12/17/2002 ---FDA Comments
02/12/2003 ---FDA Comments
02/19/2003 ---FDA Comments
02/19/2003 ---FDA Comments
02/19/2003 ---FDA Comments
03/04/2003 ---FDA Comments
03/14/2003 ---FDA Comments
05/20/2003 ---FDA Comments
06/16/2003 ---FDA Comments
06/19/2003 ---FDA Comments
06/20/2003 ---FDA Comments
06/20/2003 ---FDA Comments
07/18/2003 ---FDA Comments
08/04/2003 ---FDA Comments
09/08/2003 ---FDA comments
09/17/2003 ---FDA Comments
10/01/2003 ---FDA Comments
10/01/2003 ---FDA Comments
10/02/2003 ---FDA Comments
10/10/2003 ---FDA Comments
10/20/2003 ---FDA Comments
10/22/2003 ---FDA Comments
11/13/2003 ---FDA Comments
11/20/2003 ---FDA Comments
11/28/2003 ---FDA Comments
11/28/2003 ---FDA Comments
12/01/2003 ---FDA Comments
12/09/2003 ---FDA Comments
12/10/2003 ---FDA Comments
01/12/2004 ---FDA Comments
01/13/2004 ---FDA Comments
01/20/2004 ---FDA Comments
02/03/2004 ---FDA Comments
08/03/2004 ---FDA Comments
12/30/2004 ---FDA Comments
08/14/2012 ---FDA Completion Requirements - Support for a CRA
07/22/2011 ---FDA Compliance List-Jurisdiction
08/23/2010 ---FDA Compliance Policy Guide # 7150.13
06/30/2008 ---FDA Conditional Approval
08/27/2009 ---FDA Confidentiality Requirements for Investigators
09/11/2013 ---FDA Contact
01/14/2014 ---FDA Contact Information
01/22/2012 ---FDA Course Availability
10/12/2012 ---FDA Debarment List
07/24/2013 ---FDA Debarment List _ Medical Devices
04/04/2012 ---FDA Definition/Guidance on What Is a “Sponsor” of Research
06/29/2007 ---FDA Definitions
02/25/2011 ---FDA Definitions pertaining to Clinical Trials
09/30/2008 ---FDA Draft Guidance on the Form FDA 1572 - Questions
08/04/2015 ---FDA Draft on Informed Consent
06/14/2011 ---FDA English
08/01/2013 ---FDA Exemption
02/12/2003 ---FDA expectations on GCP
05/06/2010 ---FDA Expert-Food Supplement
05/31/2012 ---FDA Final Rule: Reporting Information Regarding Falsification of Data - Issue Date?
02/14/2012 ---FDA Financial Disclosure Forms
12/05/2002 ---FDA form 1572
12/09/2002 ---FDA Form 1572
01/15/2003 ---FDA Form 1572
11/04/2003 ---FDA Form 1572
01/09/2004 ---FDA Form 1572
01/18/2004 ---FDA Form 1572
02/28/2005 ---FDA Form 1572
04/27/2005 ---FDA Form 1572
08/31/2005 ---FDA Form 1572
10/11/2005 ---FDA Form 1572
02/17/2006 ---FDA Form 1572
03/03/2006 ---FDA Form 1572
06/11/2009 ---FDA Form 1572
09/22/2010 ---FDA Form 1572
10/20/2010 ---FDA form 1572
03/28/2011 ---FDA FORM 1572
08/24/2011 ---FDA Form 1572
09/13/2011 ---FDA Form 1572
07/12/2012 ---FDA Form 1572
03/28/2013 ---FDA Form 1572
08/02/2013 ---FDA Form 1572
04/20/2016 ---FDA Form 1572
06/09/2016 ---FDA Form 1572
03/13/2003 ---FDA Form 1572 & HIPAA
07/07/2011 ---FDA Form 1572 - Addition of Study Coordinator as Subinvestigator
04/15/2009 ---FDA Form 1572 - Analytical Research Centers
06/20/2012 ---FDA Form 1572 - Questions regarding Completion
08/12/2002 ---FDA Form 1572 - Section 3
08/13/2015 ---FDA Form 1572 - Section 6 - Sub-Investigator Names
04/19/2004 ---FDA FORM 1572 /Which of Several IRBs?
04/15/2005 ---FDA Form 1572 and Foreign Clinical Trial Sites
10/04/2002 ---FDA Form 1572 and Institutional Policies
03/15/2006 ---FDA Form 1572 and IRB
10/10/2016 ---FDA Form 1572 Box 3
10/27/2011 ---FDA Form 1572 Box 5 IRB Completion
02/23/2010 ---FDA Form 1572 Box 6-Listing of Sub-Investigators
10/04/2002 ---FDA form 1572 expiration
06/29/2010 ---FDA form 1572 Expiration Date
01/27/2006 ---FDA Form 1572 expiring 01/31/2006
10/15/2010 ---FDA Form 1572 for Specific Clinical Trials
09/28/2011 ---FDA Form 1572 Question
02/17/2012 ---FDA Form 1572 Question
06/05/2013 ---FDA Form 1572 Question
09/23/2014 ---FDA Form 1572 Question
09/13/2012 ---FDA Form 1572 Question Print Fonts
08/04/2015 ---FDA Form 1572 Versions
10/15/2012 ---FDA Form 1572, Section 3 - Additional Data Sections, How to
04/11/2012 ---FDA Form 1572--Additional Fields
11/02/2015 ---FDA Form 1572- Continuation Page
05/05/2009 ---FDA Form 1572- Expiration Date May 31, 2009
06/02/2011 ---FDA Form 1572: Effective Date
05/14/2013 ---FDA Form 1572: Infusion Nurses included as S-I
12/03/2010 ---FDA Form 1572: Subinvestigators
05/27/2011 ---FDA Form 3455
12/12/2016 ---FDA Form 3455
06/27/2012 ---FDA Form 3455 - Why is the protocol title required?
10/29/2013 ---FDA Form 3674 Field 8 Question
06/20/2013 ---FDA Form Competition
01/22/2003 ---FDA FORMs 1571 and 1572 Question
08/06/2010 ---FDA forms 1572 & 3455
01/27/2012 ---FDA Forms 3500 and 3500A
07/28/2011 ---FDA GCP
08/26/2010 ---FDA GCP Lab Certifications in Medical Device Trial
06/12/2006 ---FDA GCP Question
03/22/2010 ---FDA GCP Question Regarding Protocol Deviation
03/22/2010 ---FDA GCP Question Regarding Protocol Deviation
08/04/2009 ---FDA GCP Questions
11/05/2010 ---FDA GCP Regulations
09/04/2015 ---FDA GCP Training Online
02/18/2005 ---FDA GCP Training Program
10/22/2013 ---FDA GCP vs. ICH E-6
12/25/2014 ---FDA Good Clinical Practice Program question
07/09/2013 ---FDA Guidance
04/06/2011 ---FDA Guidance for Industry and Investigators Safety Reporting Requirements
11/13/2013 ---FDA Guidance for Sponsor-Paid Clinical Trial Subject Gifts
10/18/2010 ---FDA Guidance on 1572 - Questions 31-33
07/29/2008 ---FDA Guidance on Adverse Event Reporting Requirements
07/06/2011 ---FDA Guidance Question
12/03/2012 ---FDA Guidance Sought
05/09/2013 ---FDA Guidelines
03/17/2005 ---FDA Guidelines and Advertising
11/25/2008 ---FDA Guidelines and HIPPA Regulations
04/29/2008 ---FDA Guidelines for Dosing Volunteers in Clinical Research Trials
07/06/2005 ---FDA guidelines for subjects who drop-out of a clinical trial
04/26/2013 ---FDA Guideline Updates
06/09/2015 ---FDA IDE and Trial Registration Question
01/31/2011 ---FDA Information Sheet-GCP Manual for Investigators Revised Nov 2000
03/27/2006 ---FDA Information Sheets
03/28/2006 ---FDA Information Sheets
02/26/2008 ---FDA Insp Auth Under HIPAA
08/14/2013 ---FDA Inspection in India
02/21/2007 ---FDA Inspection of Clinical Study Sites
05/28/2015 ---FDA Inspections
03/01/2012 ---FDA Inspections Access to EMR
04/18/2013 ---FDA inspections in Canada
03/01/2010 ---FDA Inspections of Clinical Site Investigators
06/05/2015 ---FDA Inspector Compliance Manual on NDA (New Drug Application)
05/22/2008 ---FDA Insp Procedures
09/13/2010 ---FDA Investigators in Civil Litigation-Redacted
02/15/2012 ---FDA Issues Guidance on New Informed Consent Requirements
09/02/2009 ---FDA Jurisdiction
03/02/2015 ---FDA Lab Address Question
03/16/2006 ---FDA Manual
10/28/2004 ---FDA Medical Device GCP
02/09/2012 ---FDA New Informed Consent Elements 21 CFR 50.25 (c)
12/15/2006 ---FDA Notification of Site Closure
01/25/2004 ---FDA Obligation
07/18/2013 ---FDA Offices Involved in Inspections under BIMO
10/03/2012 ---FDA Phase II Trial Results?
02/16/2012 ---FDA Policy on Receiving PI CV and Licenses
07/26/2016 ---FDA Policy on Updated Risks for Approved Drugs and Subject Consent
07/26/2016 ---FDA Policy on Updated Risks for Approved Drugs and Subject Consent
01/11/2010 ---FDA policy statement
03/18/2003 ---FDA position on indemnification
03/18/2003 ---FDA position on indemnification
03/04/2003 ---FDA question
04/15/2003 ---FDA Question
04/30/2003 ---FDA question
05/16/2003 ---FDA question
06/11/2003 ---FDA question
07/16/2003 ---FDA question
07/22/2003 ---FDA question
08/15/2003 ---FDA question
08/22/2003 ---FDA question
10/01/2003 ---FDA question
10/06/2003 ---FDA question
10/17/2003 ---FDA question
02/12/2004 ---FDA Question
03/08/2004 ---FDA Question
03/24/2004 ---FDA Question
04/23/2004 ---FDA Question
06/16/2004 ---FDA Question
10/27/2004 ---FDA question
11/23/2004 ---FDA Question
02/22/2005 ---FDA Question
03/01/2005 ---FDA Question
03/01/2005 ---FDA Question
03/30/2005 ---FDA Question
04/15/2005 ---FDA Question
06/03/2005 ---FDA Question
06/14/2005 ---FDA question
08/30/2005 ---FDA question
03/03/2006 ---FDA Question
06/22/2006 ---FDA question
10/13/2006 ---FDA question
03/20/2007 ---FDA Question
08/15/2007 ---FDA question
11/08/2007 ---FDA Question
08/27/2008 ---FDA Question
12/31/2008 ---FDA Question
02/03/2009 ---FDA Question
05/06/2009 ---FDA Question
06/03/2009 ---FDA Question
09/23/2013 ---FDA Question
10/17/2006 ---FDA Question (2)
10/07/2003 ---FDA question (Mrs. Beers Block)
11/04/2005 ---FDA question (re 1572)
05/17/2005 ---FDA question (re Financial Disclosure Form)
10/19/2006 ---FDA Question- Conflict
02/04/2014 ---FDA Question - Trial/Patient Confidentiality
03/26/2009 ---FDA Question 1572 and Cooperative Group Studies
04/17/2009 ---FDA Question Follow-Up of Subjects Who Withdraw
07/30/2012 ---FDA Question Regarding Definitions
05/09/2006 ---FDA Recognition of PAHO GCPs
04/07/2011 ---FDA Recommended Frequency for Monitoring Clinical Trials
11/01/2010 ---FDA Regulated Research
04/21/2010 ---FDA Regulation for Device Central File Storage
04/27/2010 ---FDA regulation for Device Central File Storage
12/22/2004 ---FDA Regulation Inquiry
08/18/2016 ---FDA Regulations
04/11/2016 ---FDA Regulations/Clinical Trials Documentation
10/15/2015 ---FDA Regulations for Approved Drug
05/11/2004 ---FDA Regulations for DNA Banking for Research
05/23/2008 ---FDA Regulations Scope
07/17/2015 ---FDA Regulatory Oversight - Prospective And Retrospective Studies
11/11/2010 ---FDA Reporting: When the Clock Starts Ticking?
11/19/2003 ---FDA Reporting obligations
11/28/2003 ---FDA Reporting obligations
07/05/2005 ---FDA reporting question
03/23/2013 ---FDA Reporting Requirements
03/08/2013 ---FDA Reporting Requirements for Consented Study Participants
11/18/2002 ---FDA Requirement for CRFs pertaining to clinical trials
12/28/2005 ---FDA Requirement for Phase 1 Unit
12/20/2012 ---FDA Requirement Question - Follow-Up Visit Post End of Treatment.
01/12/2006 ---FDA requirements for CROs
10/21/2015 ---FDA Requirements for Retrospective-Prospective Research Studies
09/23/2011 ---FDA Requirements for Study Document Storage
05/09/2008 ---FDA Response to IRB Letter
04/01/2009 ---FDAs Acceptance of Declaration of Helsinki
01/22/2013 ---FDA Sites Down
12/08/2014 ---FDA Stance on EMR and Certified Copies
03/09/2009 ---FDA Studies
03/31/2011 ---FDA Suspension - Clinical Hold
08/30/2016 ---FDA Timing Expectation Regarding Implementations in the Protocol and ICF following IRB Approval
07/23/2015 ---FDA Warning Letter Issued to a Clinical Investigator in France
01/09/2013 ---FDA Website -- Current Investigator Disqualified List
12/19/2007 ---FDA Website- Banned Devices
01/25/2010 ---FDA Website - Therapeutic Biological Products
10/18/2014 ---FDA Website Info
10/17/2012 ---FDA_1572 - Usage of Local Language Characters
09/05/2012 ---FDF Update - Financial Significant Financial Investment Dollar Amount Change
05/01/2007 ---Feasibility in Clinical Trials
07/02/2009 ---Federal Register IRB Registration Requirements
08/10/2004 ---Federal Register Notices
10/10/2014 ---Fee for Referrals to a Clinical Trial
02/08/2013 ---F Good Clinical Practice - PDF downloads
08/26/2014 ---Filing Contracts/Clinical Trial Agreements with Regulatory Documents
06/09/2010 ---Filing Fees
05/06/2011 ---Filing of Investigators to FDA
11/07/2014 ---Filing of SIV Report at Investigator Site
07/10/2012 ---Filling Out Form FDA 1572 Online
03/12/2012 ---Final Guidance
07/07/2009 ---Final Rule for IRB Registration
04/17/2008 ---Final Study Close-Out
02/22/2007 ---Financial Assistance
01/11/2011 ---Financial Data
11/03/2003 ---Financial disclosure
11/04/2003 ---Financial disclosure
11/05/2003 ---Financial disclosure
06/18/2004 ---Financial Disclosure
06/10/2005 ---Financial Disclosure
12/08/2006 ---Financial Disclosure
04/09/2007 ---Financial Disclosure
04/21/2008 ---Financial Disclosure
01/11/2011 ---Financial Disclosure
06/01/2011 ---Financial Disclosure
11/17/2015 ---Financial Disclosure
09/28/2016 ---Financial Disclosure
03/02/2010 ---Financial Disclosure (Study Specific vs. Sponsor Specific)
03/02/2010 ---Financial Disclosure (Study Specific vs. Sponsor Specific)
12/20/2011 ---Financial Disclosure - 1 Year Follow Up
01/11/2007 ---Financial Disclosure-2
05/07/2010 ---Financial Disclosure - Investigator
12/30/2003 ---Financial Disclosure - Phase 4 Studies
10/27/2016 ---Financial Disclosure - Recruitment Incentives & Other Payments
01/09/2005 ---Financial Disclosure and 1572 in Japan
07/31/2009 ---Financial Disclosure and Clinical Laboratory Creds
07/10/2013 ---Financial Disclosure and Conflict of Interest
08/21/2009 ---Financial Disclosure by Clinical Investigators OMB #0910-0396
02/18/2005 ---Financial Disclosure Certificate
07/07/2015 ---Financial Disclosure Collection
08/18/2009 ---Financial Disclosure Doubts
04/03/2013 ---Financial Disclosure Follow up
04/22/2014 ---Financial Disclosure Follow Up
03/23/2012 ---Financial Disclosure for Clinical Investigators
08/01/2005 ---Financial Disclosure for External ECG Reader
11/18/2005 ---Financial Disclosure Form
05/18/2006 ---Financial Disclosure Form
07/09/2007 ---Financial Disclosure Form
07/13/2010 ---Financial Disclosure Form
02/23/2012 ---Financial Disclosure Form / Central Laboratory
12/05/2013 ---Financial Disclosure Form: Covered Clinical Study
05/10/2010 ---Financial Disclosure Form completion - Question
05/10/2010 ---Financial Disclosure Form completion - Question
02/13/2008 ---Financial Disclosure Forms
11/30/2010 ---FINANCIAL DISCLOSURE FORMS
02/20/2012 ---Financial Disclosure Forms
07/04/2011 ---Financial Disclosure Forms - 1 Year after Trial Completion
09/20/2013 ---Financial Disclosure Forms / Debarment Disclosure Forms in the Context of Submissions within Clinical Studies
09/30/2009 ---Financial Disclosure Forms for Phase IV studies
08/22/2016 ---Financial Disclosure Forms Original Document or Certified Copy (PDF)
02/03/2009 ---Financial Disclosure for Phase 4 Studies
02/17/2010 ---Financial Disclosure for Sponsor-investigators
07/02/2013 ---Financial Disclosure for Sub-I that did not Participate
09/06/2012 ---Financial Disclosure in a Post Approval Device Study
09/10/2008 ---Financial Disclosure in Device Trial
01/26/2011 ---Financial Disclosure in Foreign Studies
04/20/2012 ---Financial Disclosure Pre-Study Collection Timeframes
04/02/2007 ---Financial Disclosure Question
07/09/2007 ---Financial Disclosure Question
02/26/2010 ---Financial Disclosure Question
05/21/2012 ---Financial Disclosure Question
01/31/2013 ---Financial Disclosure Question
12/19/2013 ---Financial Disclosure Question
08/22/2013 ---Financial Disclosure Question & PHS Regs
02/16/2015 ---Financial Disclosure Question - FDA Form 3455
02/03/2016 ---Financial Disclosure Question - Sub-I Name Change
04/30/2014 ---Financial Disclosure Question on Annuities and Mutual Funds
10/20/2004 ---Financial Disclosure questions
12/11/2012 ---Financial Disclosure Requirements
04/17/2003 ---Financial Disclosures
11/04/2009 ---Financial Disclosures
11/06/2009 ---Financial Disclosures
03/31/2011 ---Financial Disclosures
08/05/2010 ---Financial Disclosures by Investigators
11/01/2006 ---Financial Disclosure Timelines
07/18/2015 ---Financial Disclosure Update at Sponsor Change
09/18/2007 ---Financial Interests
05/06/2008 ---Financial Interests Forms 3454, 3455 -Questions
10/14/2005 ---Financial Question
03/07/2005 ---FinanDisc Form 3454
12/11/2002 ---Finder's fees
08/17/2009 ---Finder Fees to Subjects
10/21/2008 ---Finding Clinical Trials
02/25/2005 ---FinDisc and COI for IRB Members
11/27/2006 ---Finrelations-Institutions and IRBs
07/16/2012 ---First-to-File Generic Bioequivalent Studies Question
06/23/2014 ---Five Day Reports of Emergency Use of a Test Article
04/12/2013 ---fMRI Studies in the Social Sciences
05/30/2012 ---Folding Carton Requirements
05/16/2006 ---Follow-up at End of Clinical Trial
03/12/2013 ---Follow-Up Contacts
01/25/2011 ---Follow-up on FDA Proposed Guidance
06/04/2008 ---Follow-Up on Phone Conversation Regarding Informed Consent Requirements and Subjects Approving Release of DNA Test Samples
09/13/2006 ---Follow-up on Request for assistance in Clarifying the Difference between FDA and ICH GCPs
03/17/2014 ---Follow-up question from SoCRA Workshop in Newport Beach
08/22/2006 ---Follow-up Regarding Pre-Clinical Studies with Blood and Blood Components
02/27/2015 ---Follow-up to My Questions
11/19/2013 ---Following Up - PRIMR Conference
11/06/2008 ---Follow Up
12/11/2008 ---Follow Up on Emergency Research
05/24/2006 ---Follow up to Case Report Form Query
05/17/2007 ---Font Size
05/09/2015 ---Food and Drug Clinical Trials Volunteer
04/30/2002 ---Food Product Guidance
11/21/2007 ---Foreign BIMO Regulators Inspecting US Sites
09/01/2011 ---Foreign Clinical Data Question
03/19/2004 ---Foreign Clinical Investigators on FDA List
10/20/2009 ---Foreign Clinical Sites
12/15/2003 ---Foreign clinical trial project
05/25/2004 ---Foreign Clinical Trials
05/03/2016 ---Foreign Clinical Trials
07/07/2003 ---Foreign Data
12/18/2012 ---Foreign Investigators
07/23/2012 ---Foreign Site - 1572
04/21/2009 ---Foreign Site- 1572
04/15/2009 ---Foreign Sites 1572 Question
09/27/2004 ---Foreign Sponsors for INDs
04/21/2008 ---Foreign Studies the US FDA FORM 1572
09/18/2013 ---For Help
12/18/2012 ---Form 482
10/30/2002 ---Form 483
01/29/2013 ---Form 483 Response Timing
12/14/2009 ---Form 1571 Section 11
12/20/2002 ---Form 1572
10/08/2004 ---Form 1572
03/18/2005 ---Form 1572
04/01/2005 ---Form 1572
06/23/2009 ---Form 1572
07/16/2009 ---Form 1572
05/31/2010 ---Form 1572
06/14/2010 ---Form 1572
10/18/2010 ---Form 1572
09/20/2011 ---Form 1572
10/13/2011 ---Form 1572
04/06/2012 ---Form 1572
06/04/2015 ---Form 1572
11/11/2013 ---Form 1572 - Continuation Page Section 3
08/07/2015 ---Form 1572 - Listing Multiple IRBs
09/30/2008 ---Form 1572 and Financial Disclosure Forms
06/06/2014 ---Form 1572 and Lab Procedures Done at the Clinical Site
12/13/2011 ---Form 1572 and Satellite Sites
08/31/2010 ---Form 1572 Appropriateness
08/09/2013 ---Form 1572 Box 3 and 6
04/05/2016 ---Form 1572 Completion Question/Dating the 1572
01/25/2008 ---Form 1572 Corrections Allowed
10/27/2010 ---Form 1572 Expiration
10/04/2005 ---Form 1572 in Foreign Studies
10/04/2005 ---Form 1572 in foreign studies
09/24/2009 ---Form 1572 Local Physician
01/30/2012 ---Form 1572 Question
02/27/2012 ---Form 1572 Question
07/08/2015 ---Form 1572 Question
08/13/2010 ---Form 1572 Section 3 & 6
10/01/2015 ---Form 1572 Signature Requirements - Wet Ink or PDF
12/10/2009 ---Form 1572 Sponsor Investigator
06/06/2010 ---Form 1572 Update
08/28/2009 ---Form 1572 Updating
08/03/2012 ---Form 1572 version August 31, 2011
02/24/2012 ---Form 1572, Box #4
11/20/2009 ---Form 1572- Block #4
08/11/2008 ---Form 1572- List 2 Protocols
01/18/2008 ---Form 1572- Should One Study Site Address Be Removed
02/24/2011 ---Form 3674 Guidance
04/06/2009 ---Form FDA- 1572
10/24/2003 ---Form FDA 1571
02/04/2003 ---Form FDA 1572
02/06/2003 ---Form FDA 1572
01/07/2005 ---Form FDA 1572
10/14/2005 ---Form FDA 1572
07/30/2008 ---Form FDA 1572
07/27/2010 ---Form FDA 1572
02/22/2011 ---Form FDA 1572
04/07/2011 ---Form FDA 1572
09/11/2014 ---Form FDA 1572
06/26/2012 ---Form FDA 1572 (2/12)
09/14/2010 ---Form FDA 1572 - Additional Pages
09/05/2012 ---Form FDA 1572 - Box 3 vs. Box 4
05/11/2015 ---Form FDA 1572 - Compliance Clarifications
10/30/2007 ---Form FDA 1572 - List of Investigators
11/10/2010 ---Form FDA 1572 - section 4
11/29/2011 ---Form FDA 1572 - Use of Addendum
01/21/2015 ---Form FDA 1572 and FD retention
08/10/2007 ---Form FDA 1572 Box 4
12/01/2011 ---Form FDA 1572 Completion
03/07/2014 ---Form FDA 1572 Continuation Page
02/04/2014 ---Form FDA 1572 Continuation Pages
06/24/2009 ---Form FDA 1572 Expiration
06/07/2010 ---Form FDA 1572 Expired
04/05/2011 ---Form FDA 1572 Guidance
06/10/2015 ---Form FDA 1572 Inquiries
10/04/2002 ---Form FDA1572 inquiry Importance: High
09/13/2011 ---Form FDA 1572 Query
08/17/2004 ---FORM FDA 1572 Question
04/06/2010 ---Form FDA 1572 Question
05/16/2012 ---Form FDA 1572 Question
06/20/2012 ---Form FDA 1572 Question
02/28/2013 ---Form FDA 1572 Question
09/09/2013 ---Form FDA 1572 Question
10/01/2013 ---Form FDA 1572 Question
05/07/2004 ---FORM FDA 1572 Questions
12/30/2015 ---Form FDA 1572 Questions
05/03/2004 ---Form FDA 1572 Revision
10/01/2010 ---Form FDA 1572 Revision Requirement Related to Unexpected/Unplanned Medical LOA by Primary PI
06/13/2012 ---Form FDA 1572 Section 3 vs. Section 4
09/12/2002 ---Form FDA 1572 Versions
05/28/2009 ---Form FDA 1572- Expiration Date May 31, 2009
08/02/2005 ---Form FDA 1572s
08/02/2005 ---Form FDA 1572s
05/04/2010 ---Form FDA 3455
06/22/2010 ---Forms for Auditing Data Collected from Clinical Trial
12/13/2006 ---Forms for Clinical Trials
07/22/2008 ---For Profit IRBs
01/25/2010 ---Forwarded from FDA Basics Questions
03/31/2002 ---Found it
03/01/2010 ---Fraud / Misconduct
09/08/2009 ---Fraud vs. Misconduct
03/25/2013 ---Frequency of GCP Training
09/21/2009 ---Frequent Asked Questions - Statement of Investigator (form FDA 1572)
02/24/2012 ---Full Legal Name on 1572 Section #1
02/09/2009 ---Full Time Trial Subject
02/08/2005 ---Funds Remaining After Trial
07/15/2014 ---Fw:
08/26/2016 ---FW:
05/06/2013 ---FW: Charging Subjects in Clinical Trials
03/27/2013 ---FW: FDA Final Rule: “Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products”
09/25/2006 ---FW: informed consent
02/26/2013 ---FW: IRB Registration / FWA
05/29/2014 ---FW: Request for Medical Tool Device Clinical Trial
05/30/2013 ---FW: Voice Message from [REDACTED]
08/01/2006 ---FWA & IRB registration Lapse
06/17/2005 ---FWA number
02/16/2004 ---FWA Number and ICH-GCP - Meaning of the FWA Number
04/24/2012 ---FWA Requirements
08/28/2006 ---FW Clinical Trials Website
07/28/2013 ---Fwd: External Safety Reports Not Reviewed by the PI
03/16/2012 ---FW DrugInfo Comment Form FDA/CDER Site IRB Registration
11/30/2006 ---FW Question
02/22/2010 ---FW Question on Clinical Trials Registration
12/12/2013 ---GCA
04/13/2016 ---GCLP
05/20/2002 ---GCP
07/02/2002 ---GCP
08/19/2002 ---GCP
12/10/2003 ---GCP
12/10/2003 ---GCP
04/16/2004 ---GCP
04/28/2004 ---GCP
03/11/2005 ---GCP
01/26/2009 ---GCP
06/29/2011 ---GCP
06/05/2012 ---GCP
06/12/2012 ---GCP
09/26/2012 ---GCP
09/27/2012 ---GCP
07/18/2013 ---GCP
07/30/2013 ---GCP
11/13/2013 ---GCP
09/23/2014 ---GCP
10/08/2014 ---GCP
06/14/2010 ---GCP "Washout" Question
03/20/2012 ---GCP & ICH Training Courses
02/06/2006 ---GCP's
02/05/2007 ---GCP-Audit Guidelines
08/09/2010 ---GCP-Audit Related Question
11/14/2011 ---GCP - Documents from Facilities Performing ECGs
11/10/2009 ---GCP- Drug Labeling for Double Blind Trial
07/30/2002 ---GCP - drugs vs. devices
05/07/2002 ---GCP- ESSENTIALS
07/23/2013 ---GCP - Informed Consent Language Skills
05/11/2003 ---GCP - IRB timelines
10/18/2010 ---GCP-Office Security
11/01/2010 ---GCP-Pediatrics
02/01/2008 ---GCP- Related Questions on Clinical Trials for Investigational Drug Products
07/17/2009 ---GCP- Source Documents vs. eCRF
02/04/2008 ---GCP- Timeframes for Testing
01/25/2012 ---GCP/GLP
04/12/2005 ---GCP/GLP Guidelines
04/07/2015 ---GCP/GLP in Clinical Trials
07/02/2002 ---GCP/GLP Material
03/11/2003 ---GCP/ICH guideline book
11/18/2011 ---GCP/MDR Questions
11/09/2005 ---GCP/Regulatory Questions
09/26/2002 ---GCP 4.3.3
10/11/2011 ---GCP: Inform Consent Procedure Guidance
10/19/2006 ---GCP and CFR Guideline Books
08/12/2004 ---GCP and Clinical Trials Certification Board
11/01/2010 ---GCP and Consenting Process Note
02/10/2012 ---GCP and FDA Regs
09/10/2003 ---GCP and GMP for investigational drugs
12/15/2016 ---GCP and HSP Training Question
09/22/2016 ---GCP and Human Subjects Education Certification
04/25/2006 ---GCP and Informed Consent
01/20/2016 ---GCP and Investigator Responsibilities
03/15/2010 ---GCP and Non-Regulated Trials
07/21/2009 ---GCP and Non-US studies
11/03/2014 ---GCP and Reconsenting Subjects with Updated ICFs
07/22/2015 ---GCP Auditing Course
12/27/2010 ---GCP Audit Question
06/13/2012 ---GCP Book
03/04/2003 ---GCP booklet
01/17/2006 ---GCP Booklet
03/01/2010 ---GCP Booklets
02/20/2003 ---GCP books
02/26/2013 ---GCP Cert.
04/21/2008 ---GCP Certificate
05/05/2011 ---GCP Certificate
03/29/2002 ---GCP Certification
09/13/2004 ---GCP certification
09/13/2004 ---GCP certification
09/15/2004 ---GCP certification
09/16/2004 ---GCP Certification
01/10/2005 ---GCP certification
01/15/2009 ---GCP Certification
01/07/2010 ---GCP Certification
05/24/2012 ---GCP Certification
06/21/2012 ---GCP Certification
01/02/2014 ---GCP Certification
02/13/2014 ---GCP Certification
06/03/2009 ---GCP Certification (2)
07/16/2009 ---GCP Certification (3)
12/22/2010 ---GCP Certification?
03/12/2012 ---GCP Certification Credentials
01/27/2010 ---GCP Certification for Clinical Investigators
06/12/2003 ---GCP Certification for Investigators
12/10/2009 ---GCP Certification of Investigators and Coordinators
07/25/2008 ---GCP Certification Programs
02/12/2008 ---GCP Certification Programs (2)
12/18/2007 ---GCP Certification Training
08/04/2016 ---GCP Clarification: What CRF Entries need Separate Initials and Date?
02/27/2008 ---GCP Clarification Queries
08/25/2005 ---GCP Clarifications
03/15/2005 ---GCP Class
10/26/2016 ---GCP Classes
01/11/2016 ---GCP Class Training
06/19/2007 ---GCP Clinical Research Question Regarding Anonymous Data Collection Study
07/09/2008 ---GCP Clinical Trials Guidelines Document Storage
02/01/2006 ---GCP Compliance
08/11/2005 ---GCP Compliance - REDACTED
08/22/2003 ---GCP Compliance question
09/20/2005 ---GCP Compliance Question
01/26/2009 ---GCP Compliance Question
03/25/2008 ---GCP Compliance Questions
06/22/2011 ---GCP Compliance Questions
07/24/2013 ---GCP Compliance Questions
03/22/2013 ---GCP Corrective and Preventive Action Programs- A question
07/08/2003 ---GCP course
02/03/2004 ---GCP Course
04/07/2004 ---GCP Course
04/07/2010 ---GCP Course
12/13/2004 ---GCP Course Accreditation
08/31/2007 ---GCP CRF Update Question
07/06/2012 ---GCP Current Version
08/17/2016 ---GCP Definition
08/05/2016 ---GCP Definition of a Clinical Trial
04/09/2010 ---GCP Document
01/05/2012 ---GCP Document Download
12/09/2004 ---GCP Documents
01/26/2006 ---GCP Documents
03/01/2012 ---GCP Fed Regs HSR Separation of ICFs from Docs with Study ID Numbers
07/07/2016 ---GCP for Maintaining Participant Binders
07/10/2013 ---GCP for Nutritional Products
07/06/2011 ---GCP for Physicians
04/20/2014 ---GCP for Storage and Distribution
10/07/2016 ---GCP for Survey Research
06/19/2007 ---GCP GLP University Laboratory
04/22/2012 ---GCP Gold Standards
09/17/2004 ---GCP Guidance
10/09/2014 ---GCP Guidance Document
08/07/2009 ---GCP Guidance for PI
10/14/2008 ---GCP Guidance on Sub-Investigator Licensing
03/01/2011 ---GCP Guide
03/12/2010 ---GCP Guideline Question
03/10/2003 ---GCP Guidelines
08/02/2004 ---GCP Guidelines
02/01/2008 ---GCP Guidelines
04/17/2008 ---GCP Guidelines
06/05/2009 ---GCP Guidelines
10/18/2011 ---GCP Guidelines
01/16/2014 ---GCP Guidelines
01/31/2008 ---GCP Guidelines Books- 1
10/31/2002 ---GCP guidelines for study sites
10/15/2010 ---GCP Guidelines Question
06/24/2010 ---GCP Guidelines Re: Pregnancy f/u
06/13/2012 ---GCP Handbook
06/26/2008 ---GCP ICH Bound Manuals (Miniature Paperback Books)
07/06/2012 ---GCP Implementation
10/19/2005 ---GCP in 1997
03/03/2004 ---GCP in a Histology Laboratory
06/21/2004 ---GCP in Brazil
11/06/2008 ---GCP Included in CFR 312
07/14/2002 ---GCP in data management
04/02/2010 ---GCP in FDA Regulated Trial outside US
07/13/2004 ---GCP in Foreign Countries
02/28/2003 ---GCP Information
02/28/2003 ---GCP Information
03/03/2011 ---GCP Information
04/15/2014 ---GCP Information Sheet
02/11/2014 ---GCP Informed Consent Question
02/25/2004 ---GCP inquiry
07/06/2005 ---GCP Inquiry
05/03/2010 ---GCP Inquiry
11/13/2009 ---GCP Inquiry Related to Adverse Event
12/03/2003 ---GCP in Spanish
09/10/2008 ---GCP Inspection Findings
04/19/2006 ---GCP in Trials of Licensed Products
11/16/2011 ---GCP IRB Letter Guidance
04/02/2010 ---GCP Issues on Compassionate Use
02/24/2005 ---GCP Know How
04/25/2006 ---GCP Lab Question
02/22/2011 ---GCP Law Enquiry
07/23/2007 ---GCP Literature
11/18/2005 ---GCP Manual
06/17/2002 ---GCP Manual for Investigator's?
11/18/2009 ---GCP Manuals
01/14/2011 ---GCP Manuals
01/29/2003 ---GCP Materials for Clinical Trials
12/22/2009 ---GCP Online Testing
07/25/2013 ---GCP Online Tutorial
09/26/2007 ---GCPP - Clinical Trial Archiving
06/22/2011 ---GCP PI Training Documentation Question
12/04/2008 ---GCP Presentations
02/11/2015 ---GCP Presentations Available
06/21/2002 ---GCP Purchasing Manual
11/11/2010 ---GCP Q&A Questions
08/31/2005 ---GCP Queries
02/27/2010 ---GCP Queries to FDA
02/12/2008 ---GCP Query
04/14/2010 ---GCP Query
05/05/2010 ---GCP Query
12/16/2010 ---GCP Query
04/13/2011 ---GCP Query
07/21/2011 ---GCP Query
08/01/2011 ---GCP Query
08/01/2011 ---GCP Query
06/16/2012 ---GCP Query
08/22/2012 ---GCP Query
08/28/2012 ---GCP Query
09/02/2012 ---GCP Query
09/05/2012 ---GCP Query
09/06/2012 ---GCP Query
09/10/2012 ---GCP Query
06/08/2011 ---GCP Query - COA at/in the Site TMF
12/08/2009 ---GCP Query on FDA 1572
01/27/2010 ---GCP Query on ICF Process
12/11/2009 ---GCP Query Regarding a CI Who Moved
06/04/2002 ---GCP Question
08/08/2002 ---gcp question
12/18/2002 ---GCP Question
03/05/2003 ---GCP question
03/10/2003 ---GCP question
04/03/2003 ---GCP Question
04/08/2003 ---GCP Question
07/14/2003 ---GCP Question
08/05/2003 ---GCP question
10/24/2003 ---GCP Question
02/19/2004 ---GCP Question
03/30/2004 ---GCP Question
07/07/2004 ---GCP Question
08/10/2004 ---GCP Question
10/21/2004 ---GCP Question
01/07/2005 ---GCP question
05/02/2005 ---GCP Question
07/01/2005 ---GCP Question
02/03/2006 ---GCP Question
04/03/2007 ---GCP question
11/20/2007 ---GCP QUESTION
12/19/2007 ---GCP Question
01/13/2009 ---GCP Question
01/16/2009 ---GCP Question
02/06/2009 ---GCP Question
08/23/2010 ---GCP Question
10/13/2010 ---GCP Question
10/27/2010 ---GCP Question
11/03/2010 ---GCP Question
11/19/2010 ---GCP Question
04/08/2011 ---GCP Question
04/25/2011 ---GCP Question
05/19/2011 ---GCP Question
08/19/2011 ---GCP Question
01/30/2012 ---GCP Question
03/21/2012 ---GCP Question
08/21/2012 ---GCP Question
08/21/2012 ---GCP Question
08/27/2012 ---GCP Question
09/07/2012 ---GCP Question
10/11/2012 ---GCP Question
12/09/2012 ---GCP Question
05/16/2013 ---GCP Question
05/20/2013 ---GCP Question
08/22/2013 ---GCP Question
10/02/2013 ---GCP Question
12/04/2013 ---GCP question
05/05/2014 ---GCP Question
07/02/2014 ---GCP Question
02/03/2015 ---GCP Question
08/04/2016 ---GCP Question
01/12/2010 ---GCP Question - Applicability to Non-IND Studies
05/20/2008 ---GCP Question- Auditing
02/22/2011 ---GCP Question-Blood Work
08/19/2011 ---GCP Question - Dosing
01/06/2014 ---GCP Question-Informed Consent
08/22/2012 ---GCP Question - Lost to Follow-Up
07/03/2008 ---GCP Question- Note to File
07/23/2002 ---GCP question - pt. compensation
03/03/2011 ---GCP Question-Records
06/11/2009 ---GCP Question- Subject Entry Into a Study
06/26/2015 ---GCP Question...
04/10/2015 ---GCP Question/EC chairman
02/03/2010 ---GCP Question/Legally Acceptable Representative (LAR)
02/03/2010 ---GCP Question/Legally Acceptable Representative (LAR)
02/03/2010 ---GCP Question/Legally Acceptable Representative (LAR)
06/05/2014 ---GCP Question: New Safety Information to be Disclosed to Study Participants
02/19/2015 ---GCP Question: TMF
11/01/2011 ---GCP Question about
09/09/2015 ---GCP Question about 21 CFR Part 11
01/27/2010 ---GCP Question about 1572s
04/11/2008 ---GCP Question About Non-Clinical Record Retention
02/20/2013 ---GCP Question about Training
02/20/2013 ---GCP Question about Translation
06/27/2013 ---GCP Question Concerning Clinical Trial Supplies
01/16/2008 ---GCP Question Drug Accountability
03/31/2014 ---GCP Question for Source Data
09/20/2012 ---GCP Question Obligation of Investigator Serious Adverse Event
03/10/2011 ---GCP Question on ICF
01/29/2014 ---GCP Question on ICF Amendments
10/10/2008 ---GCP Question on PRO Source Data
02/20/2014 ---GCP Question on Referencing Text across ICFs
09/16/2016 ---GCP Question on SAE Reporting to FDA by Sponsor or by Clinical Investigator
05/26/2009 ---GCP Question on SOP's and Training
04/07/2008 ---GCP Question on Training Frequency
06/27/2011 ---GCP Question Re: Clinical Testing Laboratory
05/23/2013 ---GCP Question re: Essential Documents
01/17/2011 ---GCP Question Re: Investigational Product
10/09/2013 ---GCP Question RE: Sponsor's Essential Document Maintenance
01/26/2011 ---GCP Question re: Sponsor Intervention in Clinical Trial Conduct
03/16/2015 ---GCP Question regarding a Delegation Log
11/08/2016 ---GCP Question Regarding Electronic Investigator Site Files
07/21/2004 ---GCP Question Regarding Enrollment of Investigators in a Clinical Trial
01/29/2007 ---GCP Question Regarding Incentives
09/25/2012 ---GCP Question regarding Use of Notes to File as Essential Documents
06/26/2013 ---GCP Question regarding “Current” Investigator CV
12/13/2007 ---GCP Question Re Imaging Reading Services
11/23/2011 ---GCP question related Site Signature Sheet (Delegation Log)
11/22/2013 ---GCP Question related to IRB Access to Medical Records
12/12/2006 ---GCP Question Relating to ICF
08/31/2007 ---GCP Question Re Retrospective Data Collection and ICF
04/03/2002 ---GCP Questions
10/10/2002 ---GCP questions
11/06/2002 ---GCP Questions
07/11/2003 ---GCP questions
10/01/2003 ---GCP questions
11/10/2005 ---GCP Questions
06/26/2006 ---GCP Questions
09/24/2008 ---GCP Questions
07/17/2009 ---GCP Questions
02/04/2010 ---GCP Questions
01/13/2011 ---GCP Questions
06/11/2012 ---GCP Questions
06/11/2012 ---GCP Questions
06/11/2012 ---GCP Questions
11/19/2015 ---GCP Questions
08/17/2010 ---GCP Questions - Financial Disclosure
08/17/2010 ---GCP Questions- Financial Disclosure
07/23/2014 ---GCP Questions - Investigator Record Retention Requirements
08/26/2008 ---GCP Questions Collection of CVs FD and 1572
07/24/2013 ---GCP Questions concerning Protocol Signature Pages and Local IRBs
11/11/2013 ---GCP Questions Link
07/26/2007 ---GCP Questions Pregnancies
02/23/2006 ---GCP Questions Re Compliance
04/03/2013 ---GCP Questions related to Consent Withdrawal
09/04/2013 ---GCP Questions related to Consent Withdrawal
11/02/2006 ---GCP Question Study Staff in Trial
08/06/2015 ---GCP Re-Cert
05/23/2013 ---GCP Recommendations
03/05/2013 ---GCP Refresher Training
04/18/2012 ---GCP Regulation
02/11/2009 ---GCP Regulations- Clinical Labs
10/07/2002 ---GCP Regulations and Law
01/29/2014 ---GCP Regulations or Guidelines?
03/03/2003 ---GCP regulations pamphlet
08/17/2011 ---GCP Regulations Preambles
02/11/2004 ---GCP regulatory issues
03/25/2010 ---GCP Related Question
03/30/2010 ---GCP Related Question
04/22/2010 ---GCP related question
04/08/2009 ---GCP Related Question for Observational Study
04/17/2009 ---GCP Related Question for Observational Study 2
03/11/2015 ---GCP Renewal
09/11/2013 ---GCP Renewal Training
05/09/2003 ---GCP Request
02/06/2012 ---GCP Requirement
05/08/2014 ---GCP Requirement?
06/03/2009 ---GCP Requirement Query
10/15/2013 ---GCP Requirements for Study Staff
12/10/2004 ---GCP re Source Documents in a Clinical Trial
08/06/2013 ---GCP Retraining
05/22/2015 ---GCP Retraining
09/23/2014 ---GCP Sections for Laboratories
12/01/2010 ---GCPs ICH 5.18.6
09/28/2011 ---GCPs Online Trainings
10/06/2005 ---GCP Source Documentation Questions
09/06/2012 ---GCP Speaker
03/16/2005 ---GCP Speaker?
07/15/2002 ---GCP Standards
07/15/2002 ---GCP Standards
03/03/2006 ---GCP Status of ICH
11/29/2006 ---GCP Systems Audits
05/02/2008 ---GCP Telephone Audits
10/13/2002 ---gcp training
02/10/2003 ---GCP Training
06/27/2003 ---GCP training
06/09/2004 ---GCP training
08/25/2004 ---GCP Training
12/09/2004 ---GCP Training
12/09/2004 ---GCP Training
07/03/2008 ---GCP Training
10/20/2009 ---GCP Training
01/19/2010 ---GCP Training
04/21/2010 ---GCP Training
08/13/2010 ---GCP Training
08/23/2010 ---GCP Training
10/20/2010 ---GCP Training
11/29/2010 ---GCP Training
01/31/2011 ---GCP Training
05/12/2011 ---GCP Training
05/25/2011 ---GCP Training
10/13/2011 ---GCP Training
11/14/2011 ---GCP Training
11/29/2011 ---GCP Training
12/15/2011 ---GCP Training
04/18/2012 ---GCP Training
08/03/2012 ---GCP Training
08/09/2012 ---GCP Training
08/09/2012 ---GCP Training
09/09/2012 ---GCP Training
10/04/2012 ---GCP Training
04/19/2013 ---GCP Training
04/23/2013 ---GCP Training
11/26/2013 ---GCP Training
07/26/2014 ---GCP Training
07/30/2014 ---GCP Training
11/19/2014 ---GCP Training
06/17/2015 ---GCP Training
07/20/2015 ---GCP Training
12/21/2015 ---GCP Training
12/24/2015 ---GCP Training
07/07/2016 ---GCP Training
09/27/2016 ---GCP Training
11/21/2016 ---GCP Training
09/05/2011 ---GCP Training & Certificates
06/03/2009 ---GCP Training (3)
09/15/2011 ---GCP Training - Expiration
09/27/2016 ---GCP Training - Expiration Dates?
05/24/2016 ---GCP Training/Certification Resources
08/12/2015 ---GCP Training / IRBs
11/21/2006 ---GCP Training 2
06/12/2009 ---GCP Training and Certification
09/23/2005 ---GCP Training and Certification?
11/16/2007 ---GCP Training and Qualifications
07/01/2016 ---GCP Training and Retraining Requirements
07/01/2016 ---GCP Training and Retraining Requirements
01/07/2013 ---GCP Training and Testing Materials
09/13/2013 ---GCP Training Compliance
06/25/2010 ---GCP Training Course
09/07/2011 ---GCP Training Courses
09/22/2015 ---GCP Training Documentation
12/27/2010 ---GCP Training documentation at investigational site
04/04/2016 ---GCP Training Expiration
06/16/2016 ---GCP Training for Clinical Staff
07/09/2014 ---GCP Training for IND Trial
01/19/2011 ---GCP Training for Investigators
06/15/2012 ---GCP Training For Investigators and Coordinators
05/26/2011 ---GCP Training for Investigators and Site Staff
12/15/2005 ---GCP Training for REDACTED Research Professionals
04/17/2015 ---GCP Training for Site Staff
04/17/2015 ---GCP Training for Site Staff
08/05/2013 ---GCP Training Frequency
06/19/2014 ---GCP Training Frequency
01/26/2010 ---GCP Training Guidelines
04/22/2004 ---GCP Training Information
03/29/2005 ---GCP training inquiry
06/03/2011 ---GCP Training in [redacted]
01/16/2012 ---GCP Training Modules
08/18/2009 ---GCP Training Programs
02/17/2010 ---GCP Training Question
03/28/2014 ---GCP Training Question
12/04/2016 ---GCP Training Question
10/13/2016 ---GCP Training Questions
12/15/2011 ---GCP Training Requirements
04/08/2014 ---GCP Training Requirements
12/17/2015 ---GCP Training Requirements
02/29/2012 ---GCP Training Requirements - How often is a PI Expected to Retrain
08/01/2016 ---GCP Training Requirements for Sub-Is on 1572
10/06/2011 ---GCP Training Tools
08/11/2011 ---GCP Training Websites
09/27/2010 ---GCP Train the Trainer Course
11/14/2012 ---GCP Update?
07/25/2010 ---GCP Validation Requirements
04/11/2011 ---GCP versus local law
03/14/2003 ---GCP vs CFR
05/12/2011 ---GCP vs GLP
11/14/2003 ---GCP vs GMP
08/06/2003 ---GCP Warning Letters
12/25/2016 ---GCP_Informed Consent_Copy Of ICF to Impartial Witness
08/01/2013 ---GDUFA - Who is required to Self-Identify
10/16/2003 ---General
04/15/2010 ---General Administration Practices
10/03/2002 ---general advertising for clinical trials
08/27/2004 ---General GCP Question
12/09/2002 ---general question
12/20/2002 ---General Question
09/12/2007 ---General Question
01/04/2010 ---General Question
06/07/2010 ---General Question
01/23/2012 ---General Question
11/11/2013 ---General Question about Biomarker Tissue Samples and Chain of Custody
10/16/2002 ---General question about Informed Consent
07/25/2011 ---General Question on IRB Approval without an IND and Clinical Hold and Global PI Responsibility
10/25/2016 ---General Question re: ClinicalTrials.gov Statement in Informed Consents
04/30/2004 ---General question regarding an Informed Consent for an IDE study
02/10/2014 ---General Question regarding Re-Consenting of a Subject
10/28/2011 ---General Questions
09/16/2002 ---General questions regarding Good Clinical Practice
11/09/2010 ---General Question to Inclusion of Patient
08/26/2016 ---Generic Advertising
11/05/2007 ---Generic Phone Scripts
11/05/2008 ---Generic Phone Scripts
07/16/2015 ---Generic Pre-Screen ICF
03/05/2007 ---Generic Recruitment Materials
02/06/2009 ---Genetic Testing Associated with Clinical Research
06/07/2013 ---Genetic Testing Link for GCP Questions
02/17/2015 ---Geriatric Population
09/18/2013 ---Getting involved in Clinical Trials
07/14/2003 ---GGP question
03/28/2003 ---Gifts for investigators
11/30/2007 ---Gifts to IRB
12/07/2006 ---Gifts to Subjects
11/05/2010 ---GINA
10/06/2005 ---Glossary
11/20/2013 ---GLP & GCLP
09/30/2002 ---GLP and GCP
08/03/2002 ---GLP for clinical trials
09/11/2003 ---GLP in the GCP
10/09/2003 ---GMP/GCP Question
12/07/2004 ---Good Clinical/Laboratory Practice Question
12/07/2004 ---Good Clinical/Laboratory Practice Question
05/24/2005 ---Good Clinical Practice
02/07/2006 ---Good Clinical Practice
03/09/2010 ---Good Clinical Practice
11/23/2011 ---Good Clinical Practice
12/07/2012 ---Good Clinical Practice
10/14/2014 ---Good Clinical Practice
06/14/2015 ---Good Clinical Practice
11/12/2003 ---Good Clinical Practice (GCP) Monitoring Guidelines (1988)
01/30/2013 ---Good Clinical Practice, Human Subjects
01/27/2011 ---Good Clinical Practice-Investigator Signatures
02/04/2013 ---Good Clinical Practice / ICH
01/27/2010 ---Good Clinical Practice Certificate
01/14/2014 ---Good Clinical Practice Education
03/12/2010 ---Good Clinical Practice Guidelines
11/16/2011 ---Good Clinical Practice Guidelines
03/26/2008 ---Good Clinical Practice in Pediatric Population
02/18/2011 ---Good Clinical Practice Policy and Regulation
08/10/2004 ---Good Clinical Practice Question
09/30/2015 ---Good Clinical Practice Question
07/06/2016 ---Good Clinical Practice Question Involving Rehabilitation
05/31/2013 ---Good Clinical Practice Regulations
05/16/2011 ---Good Clinical Practices
01/17/2015 ---Good Clinical Practices
11/22/2012 ---Good Clinical Practices Guideline
10/31/2003 ---Good Clinical Practices Guidelines Handbook
12/07/2007 ---Good Clinical Practices Question
11/24/2009 ---Good Clinical Practices Question
01/07/2010 ---Good Clinical Practices Question
04/30/2003 ---Good Clinical Practices Training
06/21/2006 ---Good Clinical Practice Training
12/03/2009 ---Good Clinical Practice Training
07/31/2002 ---Good Clinical Practice Training on site?
11/11/2013 ---Good Documentation Guidance Document
03/03/2016 ---Good Documentation Practice Question
12/06/2010 ---GPC: Certification/Accreditation Question
06/21/2012 ---GPC Question
03/26/2009 ---Grading Scales
07/11/2005 ---Grant
02/05/2008 ---Group Consents
03/10/2004 ---Guidance
09/07/2004 ---Guidance
11/02/2004 ---Guidance
08/31/2005 ---Guidance
07/12/2006 ---Guidance
04/05/2012 ---Guidance
03/19/2013 ---Guidance
10/01/2015 ---Guidance
09/22/2008 ---Guidance-Frequently Asked Questions-FDA 1572 Form
10/14/2009 ---Guidance-Phase 1 Trials
10/21/2004 ---Guidance Doc on Site Incentives
02/04/2011 ---Guidance Document
11/15/2010 ---Guidance Document -1572/Delegation of Authority
02/20/2009 ---Guidance Document for Form FDA 1572
05/11/2009 ---Guidance Documents
01/10/2013 ---Guidance Documents on Certified Copies
04/04/2002 ---guidance documents reproducibility requirements for clinical trials
09/09/2004 ---Guidance for Cancer Drugs
05/31/2011 ---Guidance for Clinical Study Monitoring
07/03/2012 ---Guidance for Clinical Trial Sponsors Expiration Date
12/13/2016 ---Guidance for Closing a Phase 1 Unit
05/18/2011 ---Guidance for Enrollment of Out of Town Subjects
05/30/2007 ---Guidance for Exception from Informed Consent Requirements for Emergency Research
07/30/2012 ---Guidance for Good Clinical Practice
12/01/2005 ---Guidance for Industry: Computerized Systems used in Clinical Trials
04/07/2011 ---Guidance for Industry: Financial Disclosure by Clinical Investigators
08/12/2003 ---Guidance for Industry part 11 (merely incidental use of computers, legacy system)
09/24/2015 ---Guidance for Line 4 of 1572
09/16/2015 ---Guidance for Sponsor- Investigators of INDs
03/22/2012 ---Guidance for sponsors, Investigators and IRBs - Q&A - Request for [redacted] [redacted] CRO
01/04/2010 ---Guidance for Use of Data in Specific Situations
06/28/2010 ---Guidance from FDA
08/30/2010 ---Guidance in Audit or Site Review of Investigator-Initiated Studies
07/15/2011 ---Guidance Needed
06/26/2009 ---Guidance on Announcing Clinical Trial Results
12/12/2012 ---Guidance on Clinical Trial Record Storage with Blinded Materials
07/18/2012 ---Guidance on Clinical Trials
07/25/2011 ---Guidance on Enrolling a Prisoner in a Clinical Trial
10/02/2015 ---Guidance on FDA Form 1572 Question
01/31/2011 ---Guidance on FDA Requirements
05/24/2013 ---Guidance on GCP
12/04/2012 ---Guidance on IP Storage for Purposes Other Than Use in Clinical Trial(S)
07/26/2011 ---Guidance on IRB Minutes and the Conduct of IRB Meetings
11/02/2011 ---Guidance on Monitor Queries
10/08/2008 ---Guidance on QTQTc Interval
03/12/2008 ---Guidance on Screen Failures
07/18/2012 ---Guidance on Site Equipment
05/01/2013 ---Guidance on Site Reimbursement during Clinical Trials
04/10/2014 ---Guidance on Sponsor Request
06/08/2010 ---Guidance on Third Parties Working on Trials in Sites
12/01/2011 ---Guidance on Utilizing Social Media for Clinical Research Participant Recruitment
01/25/2008 ---Guidance Practices Regarding Enticement
11/04/2003 ---Guidance Question
12/28/2006 ---Guidance Question
10/22/2013 ---Guidance regarding an IRB Issue with a PI Resignation
12/06/2012 ---Guidance regarding IRB's Policy for Review of All Unanticipated Adverse Device Effect Reports by the Convened IRB
10/20/2008 ---Guidance Regarding Sponsor Contact Involvement with Study Patients
01/08/2008 ---Guidance Re Non-English Reading Subjects
03/19/2011 ---Guidances and Policy
05/11/2009 ---Guidance v Regulations
12/16/2008 ---Guideline For Number Of Trials To Conduct- Different Regions
08/07/2007 ---Guideline for PI' s CV
04/05/2011 ---Guideline for Record Keeping of Clinical Trial
04/08/2011 ---Guideline for Record Keeping of Clinical Trial
12/11/2009 ---Guideline for Sponsor's Study Coordinator
05/27/2016 ---Guidelines
12/16/2011 ---Guidelines/Regulations of Unblinding of Participants
11/07/2006 ---Guidelines About Facilities for Phase 1 Clinical Trials
12/16/2008 ---Guidelines Clinical Trial Registries
09/23/2011 ---Guidelines for Advertisement of a Clinical Study
08/30/2002 ---guidelines for archiving of biological samples
01/26/2012 ---Guidelines for GCP Training for Sub-investigators
03/24/2004 ---Guidelines on Source Data Verification in Clinical Trials
09/04/2003 ---Guidelines re: notes to file vs. amendments
05/20/2004 ---Guidelines to Follow
05/16/2007 ---Guidelines vs. Regulations
01/26/2006 ---Guide to Good Clinical Practice
05/14/2012 ---Gummy Bear Implants
07/24/2014 ---HACCP Regulation for Fish and Fishery Products
12/17/2008 ---Hand-Dating 1572
03/25/2002 ---handbook
08/06/2014 ---Handling of Unsolicited Contacts from Patients
11/28/2006 ---Handling Patient Diary Data
02/19/2015 ---Handwriting and Typed on the Same 1572.
01/28/2008 ---Hard Copy of Patient Notes
01/26/2005 ---Hard Drive Encryption
12/14/2005 ---Harmonization
02/13/2006 ---Has 9-04 Guidance Been Finalized
06/03/2014 ---Has there been any changes since we contacted you last year?
11/10/2002 ---Have some question
06/12/2009 ---HDE Data Safety Monitoring
04/17/2007 ---Headaches As AEs
04/02/2005 ---Health - Conflict of Interest
12/27/2006 ---Health Services Research
03/24/2016 ---Healthy Volunteer Definition
04/26/2012 ---Hello
08/06/2012 ---Hello
04/23/2002 ---Help
03/21/2011 ---Help
05/12/2011 ---Help
08/24/2009 ---Help!
03/25/2004 ---Help!! (on an Investigator's Brochure)
11/17/2014 ---Help, Need some File
03/24/2009 ---Help Finding a Document
12/27/2006 ---Help in Obtaining Certificates of Confidentiality
03/27/2008 ---Help with FDA GCP Rules
07/20/2016 ---Help with Question Re Microsoft Applications and Source Documentation
10/29/2010 ---Helsinki
01/22/2015 ---Helsinki Declaration Last Version in INDS Clinical Protocol
01/23/2009 ---Helsinki Version
12/12/2006 ---HHS Conducted Funded Research by FDA
09/13/2002 ---Hi
11/30/2005 ---HIPAA
06/13/2007 ---HIPAA
09/20/2016 ---HIPAA
03/04/2003 ---HIPAA & foreign locations (Canada)
11/05/2009 ---HIPAA and Contact Info
12/03/2012 ---HIPAA and Our Participants
12/03/2012 ---HIPAA and Our Participants
03/02/2011 ---HIPAA and Relocating Research Charts
04/07/2003 ---HIPAA authorizations and IRB responsibilities
04/05/2004 ---HIPAA Compliance
04/08/2010 ---HIPAA Forms
02/04/2015 ---HIPAA Inquiry
05/13/2003 ---HIPA and the release of participant information to the participant prior to the close of a blinded clinical trial
05/08/2009 ---HIPAA Not Signed by Subject - Can Data Be Used
02/28/2003 ---HIPAA Question
05/28/2009 ---HIPAA Question
02/27/2015 ---HIPAA Question
09/13/2016 ---HIPAA Question
06/05/2009 ---HIPAA Question- Electronic Health Record
02/06/2012 ---HIPAA Question for FDA-Regulated International Studies
08/29/2002 ---HIPAA Question on CRO and Monitor Responsibility
11/04/2002 ---HIPAA questions
06/30/2003 ---HIPAA Questions
11/29/2012 ---HIPAA Regulations
02/09/2011 ---HIPAA Related Questions
11/29/2007 ---HIPAA Subject Name to Travel Agency
06/24/2016 ---HIPAA Violations
08/18/2003 ---HIPAA vs a medical release
08/23/2011 ---HIPPA question
02/04/2013 ---HIV Testing in Protocols
12/16/2004 ---HIV Testing Inquiry Response
01/31/2016 ---Holding Payments to Research Subjects
04/01/2008 ---Hold on [Redacted] Question
02/26/2013 ---Home Health Agency on 1572
10/21/2014 ---Home Health Care Provider and 1572
10/20/2011 ---Homeless Population
12/05/2012 ---Home Visits
08/28/2006 ---Hospital Medical Records
02/18/2004 ---Hospital Membership Update with FDA
10/22/2009 ---Hospital Names on Form 1572
01/15/2010 ---Hospital Regulation & Data Reporting re: Hospital Acquired Infections
03/11/2005 ---Hospital Responsibility in Research
03/17/2005 ---Hospital Responsibility in Research
09/11/2014 ---How Can I take the Course for GCP ASAP?
08/20/2004 ---How do I become a qualified clinical investigator?
09/18/2013 ---How Do I Get Started Doing a Clinical Trial
12/21/2012 ---How Do We Get A Copy of GCP Regulations or Guidance?
05/28/2008 ---How Many Studies Can CI Conduct
02/01/2006 ---How Much Patient History is Enough?
03/28/2006 ---How Often Should Info Be Collected
05/01/2015 ---How should Investigators Maintain Case Histories?
07/05/2011 ---How to Become/Register as a CRO
03/04/2010 ---How to become Investigator in Trial
07/11/2012 ---How to Blind a Clinical Trial
04/17/2012 ---How to Complete eCRFs Properly
12/15/2010 ---How to Correct GCP Error
02/20/2015 ---How to Correct the Medical Charts
08/04/2009 ---How To Find Out About Clinical Trials
10/26/2016 ---How to Handle a Subject with not satisfying all Study Entry Criteria
03/07/2006 ---How to Participate as CI in Clinical Trials
04/19/2014 ---How to Participate FDA Approved Clinical Trial
09/05/2016 ---How to Proceed When ICF Has Been Signed and There Are Findings
10/03/2010 ---How to Properly Sign and Date Signatures per GCP
04/17/2012 ---How to Refer To a Clinical Trial Results
09/07/2007 ---HUD Question
11/24/2003 ---Humanitarian Use Devices - FAQ?
07/16/2007 ---Human Participant Protections Education
11/12/2004 ---Human Research Professionals Presentations
02/23/2003 ---Human Research Question - FDA
02/06/2008 ---Human Serum Plasma Samples
09/28/2011 ---Human Subject Inform Consent Question
05/05/2004 ---Human Subject Protection/Good Clinical Practices Steering Committee
11/04/2005 ---Human Subject Protection Certification
03/07/2007 ---Human Subject Protection Policy Help
02/11/2003 ---Human subject protection training
07/23/2008 ---Human Subject Protection Training
02/11/2008 ---Human Subjects Protection Training
07/25/2003 ---Human Subjects Research Certification
12/28/2010 ---Human Subjects Training
05/16/2012 ---Human Subjects Training Requirements
09/13/2013 ---Human Tissue Analysis
09/14/2013 ---Human Tissue Analysis
08/18/2011 ---Hypothetical Related to Study Design and FDA Regs
11/19/2012 ---I'm looking for a Treatment
08/07/2015 ---I/E Criteria not included in Protocol
02/27/2011 ---I Am a Patient on a Study
12/17/2012 ---I Am Writing to Ask About the Arrangement of Clinical Trial Site
08/01/2002 ---IATA FAA Regulations For Hazardous Materials
07/08/2010 ---IATA Training
08/13/2014 ---IATA Training Documentation
05/13/2008 ---IB Question
04/05/2005 ---IBs
04/22/2011 ---IB Updating
10/31/2007 ---IC- Blind Subject
05/17/2007 ---IC-Multi-Site Trials
04/09/2007 ---IC- Test Article Safety
11/24/2009 ---IC- Using an Alias
08/09/2007 ---IC Documentation
03/10/2010 ---ICF
02/10/2011 ---ICF
01/23/2012 ---ICF
11/29/2016 ---ICF
04/29/2016 ---ICF - Possibility that the FDA may inspect the Records
06/19/2009 ---ICF-Witness Date Questions
07/29/2013 ---ICF and delay in Study Procedures
10/03/2012 ---ICF Concern
03/30/2012 ---ICF Exception
10/13/2011 ---ICF for non-English Speaking Patients
06/14/2012 ---ICF GCP Question
03/06/2015 ---ICF in EMR
10/03/2016 ---ICF Issue
10/03/2016 ---ICF Issue
10/16/2012 ---ICF New Requirement
09/25/2013 ---ICF Process Documentation in Subject Records
06/12/2006 ---ICF Process for a Non-English Speaking Person
02/16/2012 ---ICF Process Question
03/25/2009 ---ICF Query
06/23/2011 ---ICF Query
09/02/2013 ---ICF Query
06/14/2011 ---ICF Query Principal Investigator Designation
12/28/2010 ---ICF Question
03/28/2012 ---ICF Question
03/27/2014 ---ICF Question
11/04/2014 ---ICF Question
12/06/2016 ---ICF Question
12/07/2016 ---ICF Question
09/09/2011 ---ICF Question - Is reimbursement for expenses the same as payment for a study subject?
03/25/2013 ---ICF Question - Missing Page
07/15/2016 ---ICF Question on Surrogates
02/08/2011 ---ICF Question Regarding non-English Speaking Subject
06/05/2014 ---ICF Question Re Procedure Location
01/26/2015 ---ICF Requirement regarding Alternative Therapy
01/19/2016 ---ICF Requirement Regarding Alternative Therapy
05/10/2011 ---ICF Requirements for SOC Procedure
07/31/2002 ---ICFs
09/25/2007 ---ICFs and Central vs. Local IRB
08/28/2014 ---ICF Short Form
03/05/2003 ---ICF source documentation
09/09/2015 ---ICF Translations
02/21/2011 ---ICF Updates
11/27/2009 ---ICF Withdrawal from Study Treatment
09/28/2006 ---ICF Witness
08/16/2012 ---ICH-GCP
10/09/2012 ---ICH-GCP
01/21/2016 ---ICH-GCP, 4.8.10, section "m"
03/31/2011 ---ICH-GCP Contract Language and Protocol Language
09/16/2004 ---ICH-GCP E6 Section 8 point 8.3.17 and 8.3.19
08/25/2005 ---ICH -GCP Protocol Requirements
08/02/2004 ---ICH/GCP
07/11/2005 ---ICH/GCP
10/16/2015 ---ICH/GCP #5.8.1 - Request for Clarification
10/07/2013 ---ICH/GCP Question re: Site Initiation
11/30/2011 ---ICH/GCP Training at Clinical Sites
12/01/2011 ---ICH/GCP Training at Clinical Sites
01/06/2010 ---ICH4.8.9 Signing of ICF
11/12/2010 ---ICH E6 and ISO 14155 Differences
11/08/2010 ---ICH E6 Document Online
07/19/2012 ---ICH E6 Section 4.9.3
07/19/2012 ---ICH E6 Section 4.9.3c
08/19/2016 ---ICH E6(R2)
04/21/2014 ---ICH E11 Question about Pediatric Experts
11/02/2007 ---ICH GCP Essential Documents Logs Needed
05/25/2007 ---ICH GCP Guideline 312.62
06/03/2005 ---ICH GCPs
06/29/2011 ---ICH GCP Violations
11/22/2005 ---ICH Good Clinical Practice Guidelines
09/16/2008 ---ICH Guidance and Combination Products
03/13/2006 ---ICH Guidance Documents
10/04/2005 ---ICH Guidance on GCP
07/05/2006 ---ICH Guidance on InvBrochure
08/20/2004 ---ICH Guidelines
08/17/2004 ---ICH Guidelines/Good Clinical Practice and Code of Federal Regulations Book
04/12/2007 ---ICH Guidelines Clarification
12/10/2008 ---ICH Impact on GCP
04/24/2008 ---ICH Question
05/08/2008 ---ICH Question- 2
04/04/2008 ---IC Non-English Speaking Subjects
05/02/2007 ---IC Translation Service
10/23/2012 ---IDE/IRB Question
03/05/2008 ---IDE and MDRs by User Facilities
03/25/2009 ---IDE Devices Post FDA Approval
02/28/2012 ---IDE Final Report
08/01/2016 ---Identifiers
01/19/2010 ---Identifying Research Patients
12/15/2006 ---Identify Sponsor in Consent Form
03/27/2012 ---IDE Protocol
03/14/2012 ---IDE Question
06/27/2012 ---IEC/IRB Physical Meeting Necessary?
01/28/2009 ---IEC Approval in Clinical Trial
05/29/2008 ---If 1572 Update Needed
12/07/2011 ---If the Physician could be an Investigator
03/14/2012 ---If Unblind Study Nurse Could Make CRF Entries and Corrections
06/07/2012 ---IGC-GCP section 3.2.1
06/17/2010 ---IGS Regarding NDA
09/22/2004 ---I have a Question
09/12/2013 ---I have a Question
06/20/2005 ---IHC Query
08/19/2010 ---IIS/IIT study Responsibilities
01/15/2013 ---IIT-PI Responsibilities as Sponsor when Study is IND or IDE Exempt
03/05/2007 ---IITs
12/08/2006 ---Illegal Alien As a Subject
12/11/2009 ---Illiterate Subject and Informed Consent
08/02/2016 ---Image Data Retention
11/05/2013 ---Images, CD/Printed Copy Question
08/30/2010 ---Imaging Facilities on 1572
10/29/2015 ---Immediate Termination of Principal Investigator
06/21/2002 ---Impact of HIPAA on Conduct of Clinical Trials
06/06/2006 ---Impaired Physicians
11/23/2009 ---Impartial Witness
02/17/2010 ---Impartial Witness
03/01/2010 ---Impartial Witness
03/18/2013 ---Impartial Witness
07/28/2014 ---Impartial Witness
03/21/2016 ---Impartial Witness
06/03/2014 ---Impartial Witness Definition
11/02/2007 ---Impartial Witness Expectation
01/29/2013 ---Impartial Witness Presentation - NIDPOE - CI Violations
04/14/2010 ---IMP at Site and Site Initiation
02/15/2013 ---IMP Labeling Question
06/10/2015 ---IMP Labeling Requirements in USA
08/28/2006 ---Implied Consent Form
01/06/2009 ---Importance of Source Documents
05/12/2005 ---Important Question
03/20/2009 ---Important Questions
09/19/2008 ---Importing Investigational Drugs
08/08/2008 ---Incentives and Bonuses
08/08/2008 ---Incentives and Bonuses
07/14/2006 ---Incentives for Enrolling Subjects
07/13/2007 ---Incl-Excl Criteria in ICD
08/01/2013 ---Include a Mexican Clinical Site under a FDA-Approved Trial
11/01/2013 ---Including Drug Risks in a Registry Study
05/05/2006 ---Inclusion-Exclusion Criteria
03/01/2015 ---Inclusion/Exclusion
02/28/2005 ---Inclusion/Exclusion Criteria
04/06/2011 ---Inclusion/Exclusion Criteria
06/14/2005 ---Inclusion/Exclusion Criteria for Study Subjects
02/17/2011 ---Inclusion and Exclusion criteria and Use of Expired Form 3455
12/07/2006 ---Inclusion of Alzheimers Patients
09/08/2008 ---Inclusion of Sponsor Investigator Data in Industry Report
05/13/2014 ---Inclusion of Sub-investigators on 1572
02/14/2006 ---Inclusion of Women in Clinical Trial
06/06/2002 ---inclusion of women of child-bearing potential
11/18/2009 ---Incomplete Informed Consent Procedures Outside Protocol
08/13/2010 ---Incorrect Warning Letter Citation
01/21/2011 ---Increasing Subject Recruitment in an Ongoing Study Due To Higher Than Expected Drop-Out Rate
01/05/2005 ---IND
12/08/2006 ---IND # Verification
10/08/2003 ---IND - protocol amendment
02/06/2014 ---IND And IDE Validation Question
10/05/2016 ---IND Annual Report vs. Final Report Question
07/31/2003 ---IND application
05/03/2011 ---IND Application
06/23/2009 ---IND Application and Protocol
09/10/2009 ---IND Authorized Representative
03/24/2008 ---IND Contracted Site Inconsistent Data
09/08/2015 ---IND Database
03/02/2006 ---IND Data Retention Issue
11/09/2006 ---Independent Blinded Reviewers 2
06/17/2005 ---Independent vs Local IRBs
12/20/2013 ---IND Exemption
06/04/2015 ---IND Exemption
08/01/2013 ---IND Exemption and AE reporting to FDA
07/24/2014 ---IND Exempt Required Regulatory Documents
03/13/2016 ---IND Exempt Studies - Question about Prompt Reporting to the FDA
07/02/2008 ---IND Exempt Study and IC Electronic Signature
01/10/2010 ---Index of Laws on Health Care Research
06/13/2002 ---IND Financial Requirements
05/09/2008 ---IND Form 3674
01/25/2004 ---IND Guidance for University of Pittsburgh IRB
01/25/2004 ---IND Guidance for University of Pittsburgh IRB
04/07/2006 ---IND Information
02/14/2006 ---IND Investigator Brochures
07/10/2009 ---IND Labeling
07/25/2007 ---IND Labeling Requirements
04/01/2013 ---IND Medwatch and SUSAR Reporting Question
08/16/2007 ---IND Medwatch Reports
04/10/2008 ---IND Needed
09/19/2006 ---IND Number
09/24/2004 ---IND Phase II Reports
09/11/2003 ---IND Question
04/09/2004 ---IND question
02/17/2006 ---IND Question
09/09/2011 ---IND Reports for Multi-site Studies
08/21/2003 ---IND Reports to local academic IRB
01/05/2011 ---IND Requirements
05/25/2007 ---INDs - 30 Day Period - Recruitment Question
10/25/2006 ---IND Safety Letters
12/02/2008 ---IND Safety Letters to the IRB
04/04/2006 ---IND Safety Reporting
04/14/2014 ---IND Safety Reporting
02/01/2006 ---IND Safety Reporting Period
07/10/2007 ---IND Safety Reporting to Central IRBs
11/16/2015 ---IND Safety Report Policy
07/10/2003 ---IND Safety Reports
11/18/2004 ---IND Safety Reports
03/01/2012 ---IND safety reports
02/21/2011 ---IND Safety Reports - Investigator Responsibilities
11/18/2005 ---IND Safety Reports IRB Procedures
11/21/2005 ---IND Safety Reports Question
03/02/2006 ---IND Safety Reports Question
05/01/2007 ---INDs and NDAs
08/12/2013 ---IND Sponsor Responsibility Question
06/25/2013 ---IND Sponsor Transfer
06/30/2004 ---IND Study
06/06/2008 ---IND Study Non-US Investigator Reluctant to Include FDA GCPs In Contract
07/19/2011 ---IND Study Regulatory Review Question
12/16/2005 ---IND Submission Questions
05/09/2011 ---IND Trial (Unclassified)
05/05/2006 ---Industry Practice of Authorizing Exemptions to Protocol Inclusion Exclusion Criteria
01/25/2004 ---IND Verification Question
03/26/2015 ---IND Waiting Period
05/26/2015 ---IND Waiver Question
04/02/2003 ---IND with an exemption
05/18/2009 ---IND [Redacted] Use
02/06/2013 ---Infant Apnea Monitor Testing
10/16/2002 ---Info
05/16/2012 ---Info
02/19/2004 ---Info About Expanded Access Studies
05/13/2004 ---Info for 1572 Form
01/11/2007 ---Info if 1572 Required
06/11/2008 ---Info in Clinical Trials Database
05/05/2014 ---Info Needed
09/22/2008 ---Information
02/05/2009 ---Information
02/25/2010 ---Information about GCP
11/22/2005 ---Information about Investigator Fraud
06/26/2008 ---Information About Ongoing Clinical Trials
02/20/2013 ---Information about Porcine Gelatin
11/10/2015 ---Information about Randomized Manikin Study and Ethical Board
04/15/2013 ---Information Good Clinical Practice
07/16/2009 ---Information Guests Attending Clinical Trial Meetings Investigator
07/15/2005 ---Information Needed
02/03/2006 ---Information on 21 CFR Part 11
09/14/2007 ---Information on 1572s
10/12/2011 ---Information on a study procedure
03/08/2013 ---Information on Clinical Trial Site Requirements
12/21/2007 ---Information on Drug Products in Clinical Trials
02/26/2010 ---Information on Foreign CR Requirements
07/22/2012 ---Information on GCP
04/04/2002 ---Information on GCP training
04/04/2002 ---Information on GCP training
05/23/2014 ---Information on Obtaining Training and Certificate of Training on GCP from FDA
09/03/2010 ---Information on Study on Hold
06/01/2004 ---Information re: charging for an investigational product
10/30/2008 ---Information regarding [Redacted] Requirements of Unanticipated Problems
02/22/2013 ---Information related to GCP Certification Courses
04/07/2010 ---Information Request
11/01/2010 ---Information Request
02/03/2015 ---Information Request
03/30/2011 ---Information Request regarding Critical GxP Data Storage
06/10/2005 ---Information required
06/29/2011 ---Information Required Related With Delegation of Duties and Abnormal Lab Values
12/01/2010 ---Information Required Related with Informed Consent Form (ICF)
09/09/2011 ---Information Requirement
01/14/2014 ---Information Resources
08/03/2009 ---Information Sheet Guidance on Payments to Study Subjects
07/23/2009 ---Information Sheet Regarding Payment to Research Subjects
03/09/2006 ---Information to be Included on Labels for Clinical Trial Drug Supplies
01/04/2005 ---Information versus Advertising
03/27/2002 ---Informed consent
03/27/2002 ---Informed consent
06/25/2002 ---informed consent
08/21/2002 ---Informed Consent
08/21/2002 ---Informed Consent
10/30/2002 ---informed consent
02/20/2003 ---Informed Consent
04/04/2003 ---Informed consent
02/20/2004 ---Informed Consent
08/28/2006 ---Informed Consent
01/25/2007 ---Informed Consent
03/24/2009 ---Informed Consent
01/07/2010 ---Informed Consent
01/27/2010 ---Informed Consent
01/27/2010 ---Informed Consent
03/30/2010 ---Informed Consent
04/27/2010 ---Informed Consent
07/28/2010 ---Informed Consent
09/24/2010 ---Informed Consent
02/01/2011 ---Informed Consent
06/21/2011 ---Informed Consent
07/20/2011 ---Informed Consent
05/30/2013 ---Informed Consent
06/12/2013 ---Informed Consent
11/11/2013 ---Informed Consent
02/27/2014 ---Informed Consent
07/16/2014 ---Informed Consent
07/30/2014 ---Informed Consent
09/30/2014 ---Informed Consent
11/29/2016 ---Informed Consent
08/10/2015 ---Informed Consent & Collecting AEs?
06/23/2009 ---Informed Consent (Eligibility)
01/09/2007 ---Informed Consent- Date of Signature
07/02/2008 ---Informed Consent- Exception for Emergency Research
12/18/2009 ---Informed Consent- Illiterate Subjects for Non-therapeutic Trials
10/21/2015 ---Informed Consent- Items other than Study Drug Given to Subject
10/13/2015 ---Informed Consent - Patients under 18
10/31/2006 ---Informed Consent- Reconsenting
02/27/2007 ---Informed Consent - Subject Copy
06/23/2014 ---Informed Consent-Timeliness of Reconsenting
10/20/2003 ---Informed Consent/Patient Protection
03/27/2014 ---Informed Consent 21 CFR 50 (Part D)
06/19/2009 ---Informed Consent After Anesthesia
12/10/2002 ---Informed Consent Amendments Via telephone and Follow-up in Mail
12/08/2015 ---Informed Consent and Acceptance of Foreign Data
03/05/2007 ---Informed Consent and Enrollment
05/05/2004 ---Informed Consent and Expiration
02/26/2007 ---Informed Consent and NY Minor Laws
01/21/2010 ---Informed Consent and PI Participation
12/15/2008 ---Informed Consent and Re-Screening
12/15/2006 ---Informed Consent and Requiring Fasting for Visit 1
08/05/2013 ---Informed Consent and Risks for Standard of Care Procedures
10/14/2014 ---Informed Consent and Screening
04/29/2008 ---Informed Consent and Violations
02/10/2012 ---Informed Consent Best Practice
10/31/2012 ---Informed Consent by LAR with Lack of Subject Consent to Follow
02/04/2015 ---Informed Consent Content - GCP - "Timely Manner"
06/21/2007 ---Informed Consent Dispensing Meds
11/19/2013 ---Informed Consent Documents
07/11/2002 ---Informed Consent Document Storage
08/02/2011 ---Informed Consent Expiration
02/20/2009 ---Informed Consent for an Illiterate Decisionally Impaired Subject
03/07/2008 ---Informed Consent for Child
07/28/2010 ---Informed Consent for Illiterate Subject
05/25/2007 ---Informed Consent Form
09/27/2010 ---Informed Consent Form
06/27/2013 ---Informed Consent Form
01/17/2013 ---Informed Consent Form: Translations & Back Translations
05/02/2013 ---Informed Consent Form and clinicaltrials.gov
12/07/2011 ---Informed Consent Form Execution
12/07/2011 ---Informed Consent Form execution
01/10/2010 ---Informed Consent Form Question
03/26/2013 ---Informed Consent Form Question about Overwrites
12/18/2002 ---Informed Consent Form questions
11/24/2006 ---Informed Consent Form Readability Guidelines
04/02/2003 ---Informed Consent Forms
04/11/2006 ---Informed Consent for Re-Screens
04/25/2006 ---Informed Consent from a Blind Individual
05/12/2016 ---Informed Consent Guidance on Long/Short Forms for Non-English Speaking Subjects
11/24/2009 ---Informed Consent in Acute Studies Definition of Source Data
01/10/2008 ---Informed Consent in Clinical Trials
12/07/2010 ---Informed Consent in Clinical Trials
08/20/2009 ---Informed Consent Inclusion Exclusion
07/16/2014 ---Informed Consent Information Sheet Draft Guidance
10/27/2011 ---Informed Consent Inquiry
01/23/2012 ---Informed Consent Inquiry
04/29/2014 ---Informed Consent Inquiry
04/07/2010 ---Informed consent in subjects with wavering capacity
12/13/2011 ---Informed Consent Issue
06/26/2006 ---Informed Consent Issues
11/07/2012 ---Informed Consent not Feasible for Non-IVDD Study involving Deidentified Tissue Samples
11/18/2010 ---Informed Consent Obtaining Information after Withdrawal of Consent
04/03/2008 ---Informed Consent of an Illiterate Subject
06/25/2009 ---Informed Consent of Cognitively Intact Quadriplegic Subjects
08/12/2015 ---Informed Consent Outside the US and 50.25C
04/18/2003 ---Informed Consent Procedure
05/31/2011 ---Informed Consent Procedure-Signed Copy
03/22/2004 ---Informed Consent Process
02/29/2008 ---Informed Consent Process
06/06/2011 ---Informed Consent Process
05/15/2015 ---Informed Consent Process
05/19/2015 ---Informed Consent Process
03/25/2011 ---Informed Consent Process - Study Personnel
10/18/2012 ---Informed Consent Process Documentation
07/06/2009 ---Informed Consent Process in FDA Regulated Trials
04/03/2007 ---Informed Consent Query
12/10/2002 ---informed consent question
03/05/2003 ---Informed Consent Question
02/14/2006 ---Informed Consent Question
03/15/2006 ---Informed Consent Question
11/24/2006 ---Informed Consent Question
11/08/2007 ---Informed Consent Question
08/04/2009 ---Informed Consent Question
02/22/2010 ---Informed Consent Question
07/23/2010 ---Informed consent question
04/20/2011 ---Informed Consent Question
04/27/2011 ---Informed Consent Question
02/27/2012 ---Informed Consent Question
04/08/2013 ---Informed Consent Question
07/09/2013 ---Informed Consent Question
08/15/2013 ---Informed Consent Question
09/26/2013 ---Informed Consent Question
10/14/2013 ---Informed Consent Question
08/10/2015 ---Informed Consent Question
09/12/2015 ---Informed Consent Question
09/17/2015 ---Informed Consent Question
12/13/2013 ---Informed Consent Question -- Signature of Subject
08/28/2006 ---Informed Consent Question- Changes
03/21/2012 ---Informed Consent Question and ClinicalTrials.gov
04/03/2002 ---Informed Consent Questions
03/09/2015 ---Informed Consent Questions
07/29/2009 ---Informed Consent Regulations
02/25/2016 ---Informed Consent Retention Question
10/28/2009 ---Informed Consent Risks Section
03/25/2002 ---Informed consents
11/14/2003 ---Informed Consents
08/08/2013 ---Informed Consents
07/19/2014 ---Informed Consents - Expiration
09/09/2014 ---Informed Consent Signature
02/08/2016 ---Informed Consent Signature Question
07/10/2015 ---Informed Consent Signature Requirement
11/13/2013 ---Informed Consent Statement for Studies Registered on clinicaltrials.gov
04/13/2012 ---Informed Consent Time of Sign-Off
03/09/2015 ---Informed Consent Translations
12/13/2011 ---Informed Consent Update
03/20/2006 ---Informed Consent Waivers
02/15/2007 ---Informing Patients of Changes in PIs
08/02/2016 ---Informing Subjects of New Information
10/30/2011 ---Infusion Nurses
08/11/2006 ---Initial and Date Stamper Use
11/08/2012 ---Initialing/Dating Source Documentation
12/15/2014 ---Initial Investigational Drug Shipment
12/06/2010 ---Initials on consent form
04/02/2003 ---Initials on consent forms
02/17/2009 ---Initiation Report Left at Investigator Site
01/05/2011 ---Ink Color Question
08/17/2009 ---In Need of Your Expertise
10/17/2003 ---Inpatient Research Facility
08/23/2010 ---Input on Research Involving Children
10/23/2012 ---Inquire: Guidance for Institutional Review Boards
06/04/2015 ---Inquire about using a Potential New Food Ingredient in Clinical Trials
06/06/2005 ---Inquiry
12/21/2005 ---Inquiry
07/06/2006 ---Inquiry
07/31/2006 ---Inquiry
06/10/2008 ---An Inquiry
07/15/2009 ---Inquiry
10/13/2009 ---Inquiry
03/10/2010 ---Inquiry
03/17/2010 ---Inquiry
07/13/2010 ---Inquiry
07/28/2010 ---Inquiry
08/25/2010 ---Inquiry
09/09/2010 ---Inquiry
10/14/2010 ---Inquiry
10/17/2010 ---Inquiry
11/10/2010 ---Inquiry
11/16/2010 ---Inquiry
12/22/2010 ---Inquiry
01/06/2011 ---Inquiry
01/20/2011 ---Inquiry
03/09/2011 ---Inquiry
05/06/2011 ---Inquiry
07/15/2011 ---Inquiry
09/11/2013 ---Inquiry
12/19/2013 ---Inquiry
03/24/2014 ---Inquiry
06/06/2016 ---Inquiry
09/06/2011 ---Inquiry - Co-Investigators
02/28/2011 ---Inquiry-EKG recording
07/01/2003 ---Inquiry - IND Safety Reports
10/15/2014 ---Inquiry: Are there GCP Mandatory Regulations on...
05/06/2011 ---Inquiry: Risk to Subject
02/24/2010 ---Inquiry about Access to Medical Records by Monitors
02/05/2013 ---Inquiry about Clinical Trial Site-regarding
10/22/2013 ---Inquiry about GCP Inspections
02/14/2008 ---Inquiry about GDEA
05/29/2015 ---Inquiry about ICH- GCP Guideline
06/11/2014 ---Inquiry about Pharmacovigilance Activities - Reg
12/22/2014 ---Inquiry about Remote Inspection
01/28/2015 ---Inquiry about Scanning Data
01/18/2011 ---Inquiry Clinical Hold
03/08/2011 ---Inquiry Concerning Storage of an Investigational Product
05/11/2011 ---Inquiry DOA/1572
04/05/2013 ---Inquiry Financial Disclosure- Are investors in a Privately-Held Company considered Sponsors
06/17/2004 ---Inquiry from [Redacted]
10/04/2011 ---Inquiry on Guidance Document [redacted]
11/05/2007 ---Inquiry on IRB Composition
09/02/2008 ---Inquiry on Quality System Requirements for IRBs
05/24/2005 ---Inquiry Prep Site for Inspection
02/23/2012 ---Inquiry regarding Clinicaltrials.gov Identifier: NCT01290341
12/23/2009 ---Inquiry Regarding Collection and Reporting of SAEs to IRB
05/11/2016 ---Inquiry Regarding Completion of the Research and IRB Record Retention
01/30/2013 ---Inquiry Regarding Non-Human Subjects Research Determination for a Project Involving an OTC Monograph
04/13/2014 ---Inquiry Regarding Regulations regarding Adult Stem Cell Transplantation in Humans
08/31/2005 ---Inquiry regarding SAEs
06/22/2010 ---Inquiry Regarding Shipping Nude Vials to a Site for a Clinical Trial
12/10/2012 ---Inquiry regarding SOC Drugs Risks in Consent Forms
01/12/2010 ---Inquiry Regarding SOP Templates and Forms for Clinical Research Site
01/26/2015 ---Inquiry regarding Third Party Safety Reports
01/20/2010 ---Inquiry Re Obtaining Informed Consent
07/25/2008 ---Inquiry RE Subject Incarcerated (then released) Post Enrollment
10/14/2008 ---Inquiry Study Data Archiving
01/19/2010 ---Inquiry Trial Master File Essential Documents FDA
03/28/2012 ---Inquiry via NIH/NLM
04/19/2007 ---Inspection Classifications
02/20/2015 ---Inspection Fees
09/16/2010 ---Inspection History Databases
10/24/2002 ---Inspection of a new site
05/20/2013 ---Inspection Preparation at Clinical Investigator Site
04/06/2010 ---Inspection Question
06/14/2010 ---Inspection Question
09/16/2014 ---Inspection Reports
10/27/2009 ---Inspections CBER Website
05/24/2010 ---Inspections CBER Website - Follow-up
02/19/2008 ---Institutional Official Serving on the IRB
12/30/2005 ---Institutional Responsibilities for Conduct of Research
06/06/2005 ---Institutional Review Board - ICH Guideline (E6)
06/06/2005 ---Institutional Review Board - ICH Guideline (E6) Dear
04/17/2014 ---Institutional Review Board Protocol/Amendments/Informed Consent Form Signed Approval Letters
10/06/2010 ---Institutional Review Board Questions
12/15/2010 ---Institution Name Change
05/04/2007 ---Institutions Engaged in Research
09/17/2009 ---Instructions for 1571
03/10/2009 ---Insurance Co-pay Coverage for Research Subjects
10/10/2007 ---Insurance Requirements for Clinical Trials
03/05/2008 ---Intent-to-Treat Population
01/31/2008 ---Interactive Double Duty Data Entry
10/19/2004 ---Interim Analysis Data
05/24/2007 ---Internal Audit Monitoring of NIH Sponsored Trials
12/30/2010 ---Internal Audits
05/29/2013 ---Internal Audits
10/01/2008 ---Internal Monitoring
04/29/2009 ---International AE Reporting Requirements
09/25/2008 ---International Clinical Trials Conference
04/25/2002 ---International criteria
07/25/2011 ---International Inspections - Warning Letters
08/24/2011 ---International Law
07/01/2009 ---International Sponsors and Requirements for ICH GCP
07/07/2006 ---International Studies
09/24/2012 ---International SUSAR
01/29/2004 ---Internet Postings
01/29/2004 ---Internet Postings
09/11/2013 ---Interpretation for Reviewing Potential Study Subject Records
02/27/2008 ---Interpretation of 21CFR312.57(c)
08/09/2005 ---Interpretation of 56.114
03/10/2014 ---Interpretation Question
05/05/2006 ---Interpretation to 21CFR 312.30(b)
10/21/2003 ---Interstate Shipment of IND Drug for Clinical Trials
09/05/2011 ---Interventional and Non-Interventional Trials Definitions
09/24/2004 ---Intrinsa patch
07/21/2012 ---Invention
04/16/2011 ---Inventory Control
08/04/2010 ---Investigational Device Question
06/25/2002 ---Investigational Drug Accountability
09/06/2007 ---Investigational Drug Administration
10/21/2002 ---Investigational Drug Compliance for Clinical Trials
04/29/2009 ---Investigational Drug Expiry Date Extension - Labeling
09/06/2006 ---Investigational Drug Labeling Re Expiration Date
10/24/2008 ---Investigational Drug Policy Procedure
08/22/2006 ---Investigational Drug Question
05/17/2006 ---Investigational Drugs
07/31/2009 ---Investigational Drugs Requiring Double Lock System
09/05/2007 ---Investigational Drug Therapy
01/13/2016 ---Investigational Medicinal Product Labeling requirement for USA
02/29/2016 ---Investigational Medicinal Product Labeling Requirement for USA
04/07/2003 ---Investigational Pharmacist
01/22/2013 ---Investigational Product
03/31/2012 ---Investigational Product: Clinical Trials
02/22/2007 ---Investigational Product Label Question
07/14/2006 ---Investigational Product Management
11/25/2009 ---Investigational Product Storage
08/07/2013 ---Investigational Product Temperature Monitoring
01/29/2015 ---Investigational Product Temperature Monitoring
02/13/2012 ---Investigative Site Administrative Structure
11/04/2003 ---Investigator
04/15/2005 ---Investigator's Brochure
12/19/2011 ---Investigator's Brochure for Device Trials
05/27/2011 ---Investigator's Dating Documents
05/30/2012 ---Investigator's Essential Documents to Be Kept Out of the Site
09/18/2009 ---Investigator's Financial Disclosures and Clinical Trials
03/18/2008 ---Investigator's Signature
10/18/2003 ---Investigator's Signature on Consent
08/01/2012 ---Investigator-Initiated Clinical Trials
04/12/2002 ---Investigator-Initiated Research
05/04/2010 ---Investigator-Initiated Study
07/12/2010 ---Investigator - Observational Study
06/04/2009 ---Investigator Agreements - Sub-Investigators
03/25/2011 ---Investigator Brochure Guidance for Medical Devices
04/20/2005 ---Investigator Brochures
09/26/2012 ---Investigator Coverage
12/04/2008 ---Investigator Discontinuation
01/01/2010 ---Investigator filling in the 1572
04/13/2009 ---Investigator GCP Training
10/13/2015 ---Investigator GCP Training Online
10/13/2015 ---Investigator GCP Training Online
08/24/2011 ---Investigator Initiated IND Monitoring
08/06/2013 ---Investigator Initiated IND Submission
04/16/2011 ---Investigator Initiated Inquiry
10/14/2005 ---Investigator initiated studies
07/21/2014 ---Investigator Initiated Study
04/27/2015 ---Investigator Initiated Study
08/30/2005 ---Investigator Initiated Study Compliance
09/09/2011 ---Investigator Initiated Trial
06/13/2002 ---Investigator Initiated Trials
12/18/2008 ---Investigator initiated trials
12/18/2008 ---Investigator Initiated Trials
11/18/2009 ---Investigator Leave of Absence
12/11/2009 ---Investigator License Requirements
10/30/2006 ---Investigator Listing Question
06/13/2011 ---Investigator Meeting Expenses
11/17/2004 ---Investigator Meetings
03/09/2005 ---Investigator Meetings
02/01/2006 ---Investigator Meetings
06/10/2011 ---An Investigator Moved His Office
05/24/2007 ---Investigator Name- 1572
12/05/2011 ---Investigator Names on 1572
03/09/2009 ---Investigator Non-Compliance
11/25/2009 ---Investigator Oversight
11/25/2009 ---Investigator Oversight
06/24/2011 ---Investigator Oversight
06/26/2006 ---Investigator Own IND Study
04/18/2008 ---Investigator Payment Question
11/03/2009 ---Investigator Qualifications
11/20/2007 ---Investigator Record Retention
04/08/2010 ---Investigator Records
01/27/2016 ---Investigator Records
01/20/2010 ---Investigator Records in Event of Research Practice Closure
05/17/2010 ---Investigator Recruiting
09/24/2010 ---Investigator Reporting
03/10/2011 ---Investigator Reports
08/17/2010 ---Investigator Responsibilities-Appropriate Delegation of Tasks
12/08/2015 ---Investigator Responsibilities/Delegation of Authority
05/05/2011 ---Investigator Responsibilities Clarification
03/18/2008 ---Investigator Responsibility Questions
02/08/2010 ---Investigator Responsibility Specifically Detailed in Protocol
01/07/2015 ---Investigator Reviewing and Signing eCRFs
03/19/2009 ---Investigators Brochure
08/24/2012 ---Investigator Signature on EKG
05/19/2009 ---Investigator Signature on Financial Disclosure
01/24/2013 ---Investigator Signature on IND Safety Reports
05/04/2005 ---Investigator Signatures
03/26/2002 ---Investigator Site control of source documents
04/03/2007 ---Investigator Site Part 11 Question
07/23/2007 ---Investigator Site SOPS
07/26/2010 ---Investigator Site [Redacted] Certified Lab not being on the 1572 Form
01/23/2013 ---Investigators Listed on ICF and 1572
10/23/2013 ---Investigator Sponsored Research Query
12/22/2005 ---Investigator Sponsored Trials
04/01/2009 ---Investigator Sponsored Trials
03/02/2012 ---Investigators Training
05/09/2012 ---Investigator Submission of Protocol Deviations to IRB
02/24/2010 ---Investigator supervisory responsibilities for sponsor field personnel.
10/13/2006 ---Investigator Terminated
03/24/2016 ---Investigator Terminated & Reported to FDA
08/17/2009 ---Investigator Un-Signing a 1572
09/04/2015 ---Invitation to Participate in Biotechnology Workshop
12/10/2012 ---Involving a Nurse Practitioner as Sub-Investigator in Clinical Trial
01/20/2010 ---IP Label Question for Reduced Dose
01/20/2010 ---IP Label Question for Reduced Dose
08/20/2003 ---IRB
04/15/2005 ---IRB
03/16/2007 ---IRB
07/23/2007 ---IRB
05/13/2009 ---IRB
11/20/2012 ---IRB
09/18/2013 ---IRB
03/08/2010 ---IRB's
03/24/2004 ---IRB's Continuing Review
12/08/2006 ---IRB-Approved Consent Form
07/24/2013 ---IRB-IEC Membership
02/06/2009 ---IRB-IND Approval Order Question
03/03/2005 ---IRB/Ethics annual review
03/03/2005 ---IRB/Ethics annual review
12/20/2010 ---IRB/IEC
06/05/2007 ---IRB/IND
12/09/2015 ---IRB Acceptance of Final Sponsor Report
09/20/2005 ---IRB activities
07/07/2015 ---IRB Address Change
08/29/2007 ---IRB Administrative Review
09/06/2015 ---IRB and Continuing Review
09/09/2015 ---IRB and Continuing Review
09/17/2004 ---IRB and ICF Requirements
06/06/2002 ---IRB and Informed Consent Regulations
06/16/2009 ---IRB and Informed Consent Revisions Based on New Risk Information
02/28/2008 ---IRB and Investigator Meeting
02/01/2006 ---IRB and Medwatch Reports
07/31/2003 ---IRB and Part 11 Compliance Question
12/07/2006 ---IRB and Patient Registries
12/07/2006 ---IRB and Suspensions
07/19/2007 ---IRB Approval
03/13/2008 ---IRB Approval
08/29/2008 ---IRB Approval
10/11/2012 ---IRB Approval
06/24/2013 ---IRB Approval
08/09/2016 ---IRB Approval
04/07/2011 ---IRB Approval and the Regulations
06/05/2007 ---IRB Approval Before IND
03/19/2010 ---IRB approval for written information to be provided to subjects
03/06/2006 ---IRB Approval Letter
05/23/2008 ---IRB Approval Letter Details
01/28/2004 ---IRB approval notices
06/07/2012 ---IRB Approval of Clinical Trials.gov
06/05/2014 ---IRB approval of Dear Dr Letters
06/03/2002 ---IRB approval of herbal products
03/30/2010 ---IRB approval of Protocol
10/06/2003 ---IRB approval of protocol amendment for extension study
04/23/2008 ---IRB Approval of Study Ads
04/06/2009 ---IRB Approval Question Compassionate Use
07/10/2009 ---IRB Approval Required for Referral Sites
07/19/2002 ---IRB approvals
03/04/2004 ---IRB approval status
05/02/2007 ---IRB Authority
11/26/2007 ---IRB Authority
06/08/2009 ---IRB Board Member Interpretations of SOP's
05/23/2008 ---IRB Certification
01/23/2012 ---IRB Chairman
04/30/2004 ---IRB Chair Signature Stamps
05/19/2006 ---IRB CI Wanting to Terminate Study
07/13/2012 ---IRB Clarification Query
02/02/2006 ---IRB Closing-Transfer
06/03/2012 ---IRB Compliance
05/03/2012 ---IRB Compliance Issues with Protocol Waiver of Jurisdiction/Accept Approval of Foreign IRB
08/17/2009 ---IRB Compliance Manual
08/17/2009 ---IRB Compliance Program Manual Not on FDA Internet
07/29/2009 ---IRB Compliance Question
08/31/2005 ---IRB composition and related procedures
04/20/2007 ---IRB Conflict of Interest Quorum
08/07/2008 ---IRB Conflicts
06/15/2004 ---IRB Conflicts of Interest
08/07/2008 ---IRB Conflicts Separation of Business and Ethics
01/09/2007 ---IRB Continuing Review
12/10/2009 ---IRB Continuing Review and Informed Consent Submission
02/06/2005 ---IRB Continuing Review Question
01/26/2015 ---IRB Convened meetings
04/21/2008 ---IRB Coverage for Institutions
01/26/2009 ---IRB Coverage Pertaining to Approved Studies
08/19/2008 ---IRB Date Stamps On Documents
10/16/2014 ---IRB Deferral Letter Inquiry
10/14/2010 ---IRB Documentation of AE Reviews for Studies using the Same Investigational Drug
11/27/2006 ---IRB Documentation Questions
05/09/2005 ---IRB documents and email
03/02/2010 ---IRB Doubt
04/08/2010 ---IRB doubt
10/02/2014 ---IRB Ethical Inquiry
09/25/2010 ---IRB evaluation of the scientific merit of a proposed study
04/26/2012 ---IRB Exempt
11/06/2008 ---IRB Expedited Approval of New Clinical Investigators
02/01/2010 ---IRB Expedited Review
10/27/2010 ---IRB Full Committee Review Question on CITI Program
05/11/2011 ---IRB FWA Confirmation
03/09/2012 ---IRB GCP Question
01/17/2006 ---IRB HIPPA Guidance
01/05/2007 ---IRB IEC Role in Clinical Trials
03/17/2011 ---IRB IND Verification Question
08/26/2008 ---IRB Info & the 1572
04/30/2002 ---IRB Information
04/30/2002 ---IRB Information
08/18/2008 ---IRB Information and the 1572
01/03/2011 ---IRB Inquiry
09/22/2014 ---IRB Inquiry
07/16/2002 ---IRB Inspection Info
10/28/2009 ---IRB Inspection in [Redacted]
11/15/2007 ---IRB Inspection List
12/01/2014 ---IRB involvement
08/09/2012 ---IRB Jurisdiction
10/23/2007 ---IRB Jurisdiction Question
04/21/2008 ---IRB Lapse of Approval
10/18/2006 ---IRB Meeting
06/30/2004 ---IRB Meetings convened via Teleconference
02/04/2009 ---IRB Member COI Question
12/04/2013 ---IRB Member Lab Director Voting
07/31/2003 ---IRB membership
11/08/2007 ---IRB Membership
04/08/2013 ---IRB Membership
04/14/2013 ---IRB Membership
04/17/2013 ---IRB Membership
09/08/2014 ---IRB Membership
02/20/2007 ---IRB Membership- GCP Compliance
11/08/2011 ---IRB Membership - Non-scientist
12/04/2011 ---IRB Membership - [Redacted] Affirms its Meeting is correctly constituted but Refused to Release Member Names
04/26/2004 ---IRB Membership and Designation of Scientist/Non-Scientist
01/15/2015 ---IRB Membership List Question
02/27/2007 ---IRB Membership Question
09/16/2008 ---IRB Membership Question
02/17/2011 ---IRB Membership Rosters
01/05/2002 ---IRB move
12/17/2013 ---IRB Name Change
09/05/2007 ---IRB of Non-FDA Devices
02/18/2010 ---IRB of Record for a CRO
02/04/2014 ---IRB Ongoing Review of Studies Closed except for Data Analysis
12/14/2007 ---IRB Oval of Medical History Form- Is This Required
09/09/2016 ---IRB Oversight for Ongoing Post-Trial Assessments of Study-Related Safety Events
07/22/2011 ---IRB Oversight of IVD Studies Using De-Identified Archived Specimens
05/20/2005 ---IRB Panels, Reciprocity
06/03/2008 ---IRB Panels and Part 11 Questions
02/11/2013 ---IRB Periodic Safety Reporting
11/13/2007 ---IRB Physical vs. P.O. Box Addresses
06/06/2011 ---IRB Primary Reviewer System Question
02/01/2008 ---IRB Procedure for Closing an IRB
10/28/2003 ---IRB processes
06/27/2005 ---IRB Processing Documentation
07/30/2013 ---IRB Qualified Personnel
09/07/2004 ---IRB question
04/29/2005 ---IRB question
08/18/2005 ---IRB question
10/21/2005 ---IRB Question
04/25/2006 ---IRB Question
11/13/2007 ---IRB Question
05/21/2008 ---IRB Question
07/07/2010 ---IRB Question
07/09/2010 ---IRB question
08/13/2010 ---IRB Question
10/17/2012 ---IRB Question
07/28/2014 ---IRB Question
07/28/2014 ---IRB Question
11/14/2014 ---IRB Question
05/11/2016 ---IRB Question
12/27/2006 ---IRB Question 2
05/03/2012 ---IRB Question about Written Material
12/15/2009 ---IRB question for You from [Redacted]
03/24/2005 ---IRB Questions
12/08/2006 ---IRB Questions
02/10/2009 ---IRB Questions
05/31/2013 ---IRB Questions
02/22/2005 ---IRB questions - non -inferiority
01/26/2015 ---IRB Quorum
09/10/2013 ---IRB Quorum 5 Members
05/25/2007 ---IRB Quorum Definition
08/22/2016 ---IRB Quorum Question
01/05/2007 ---IRB Quorum Voting
08/30/2004 ---IRB Record Keeping Requirements
05/27/2010 ---IRB Record Retention
12/06/2016 ---IRB Record Retention after IRB Transfer
07/19/2010 ---IRB Record Retention Question
01/11/2005 ---IRB records
01/25/2016 ---IRB Records and Part 11 Compliance
06/19/2009 ---IRB Registration
02/10/2011 ---IRB Registration
11/29/2011 ---IRB Registration
11/02/2015 ---IRB Registration
02/27/2013 ---IRB Registration / FWA
09/23/2009 ---IRB Registration and IRB Regulatory Compliance
07/22/2009 ---IRB Registration Assistance
08/25/2009 ---IRB Registration Effect on Active Studies
09/22/2009 ---IRB Registration Foreign IRB IECs
06/18/2009 ---IRB Registration for EX-US IRBs
08/25/2009 ---IRB Registration for FDA
03/02/2006 ---IRB Registration for Foreign Studies
09/23/2010 ---IRB Registration Info Request
03/15/2010 ---IRB Registration Information
08/27/2009 ---IRB Registration Question
01/12/2012 ---IRB Registration Question
08/11/2009 ---IRB Registration Requirements
07/01/2009 ---IRB Registration Rule
04/30/2007 ---IRB Reporting
09/04/2013 ---IRB Reporting Requirements for IND Exempt Studies
01/11/2010 ---IRB Reporting to FDA, Follow Up from PRIM&R Presentation
05/21/2008 ---IRB Reports to Institution
12/10/2007 ---IRB Request for IND Information
08/29/2007 ---IRB Request for Information on Promotional Materials
01/06/2003 ---IRB requesting Budget for approval of study
12/30/2003 ---IRB requesting Budget for approval of study
05/20/2013 ---IRB Requests Copy of Patient Consent Signature Page
03/21/2013 ---IRB Requirements for Site
07/23/2014 ---IRB Research
07/23/2014 ---IRB Research
03/16/2015 ---IRB Responsibility for Disclosure of 21 CFR 50.25 C for Applicable Clinical Trials
07/17/2006 ---IRB Responsibility for Phase IV studies
05/19/2003 ---IRB review
09/13/2005 ---IRB Review
09/13/2005 ---IRB Review
10/05/2011 ---IRB Review
06/04/2008 ---IRB Review- Community Consultation- Public Disclosure Plans
09/29/2009 ---IRB Review- Non-US Study
06/08/2012 ---IRB Review and INDs
01/13/2015 ---IRB Review Models
08/12/2009 ---IRB Review of Advertisements
08/05/2008 ---IRB Review Of AE Reports
09/18/2008 ---IRB Review of AE Reports
08/21/2002 ---IRB review of approved marketed products
08/21/2002 ---IRB review of approved marketed products
04/11/2008 ---IRB Review of cGMP Facilities
08/04/2008 ---IRB Review of CRF
10/03/2003 ---IRB review of final reports
09/04/2012 ---IRB Review of Human Factors/Usability Testing
05/23/1015 ---IRB Review of IND Exempt Studies
02/22/2008 ---IRB Review of Medical Questionnaires
03/25/2013 ---IRB Review of Non-Specific NIH Website Language
10/22/2015 ---IRB Review of NSR Device
11/27/2005 ---IRB Review of Phase IV Studies
11/29/2005 ---IRB Review of Phase IV Studies
01/16/2003 ---IRB review of protocol information
08/31/2010 ---IRB Review of Research with an IND
06/29/2007 ---IRB Review of Stand-Alone HIPAA Authorizations
06/11/2015 ---IRB Review of Studies Requiring an IND
03/15/2016 ---IRB Review of Study Involving Marketed Spectacles
01/14/2016 ---IRB Review of Sub-Investigators
04/30/2007 ---IRB Review of the FDA 1572
08/18/2005 ---IRB Review of Written Info Given to Subjects
04/29/2011 ---IRB Review Question
07/31/2014 ---IRB Review Requirement for Non-Treatment Development Project
09/20/2012 ---IRB Review versus Approval
07/13/2006 ---IRB Roles
12/06/2011 ---IRB Roster & IRB Compliance
10/28/2014 ---IRB Roster Change
07/16/2004 ---IRB Rosters
02/21/2007 ---IRBs
07/18/2003 ---IRBs' obligation to ensure that an investigator has obtained an IND
06/18/2009 ---IRBs- Electronic Communications
06/02/2003 ---IRBs and IECs
10/01/2009 ---IRBs and Protocol Deviations
08/29/2008 ---IRB Separation of Review
12/20/2012 ---IRB Situation Question
03/14/2011 ---IRB Study Approval
02/15/2016 ---IRB Study Transition
07/15/2003 ---IRB subcommittee
01/30/2013 ---IRB Submission Question
07/06/2009 ---IRB Submitted Study
04/07/2005 ---IRBs versus IECs
12/02/2004 ---IRB Violation?
02/07/2005 ---IRB Waiver
02/04/2007 ---IRB Waiver of Jurisdiction
06/02/2015 ---IRB Waiving Jurisdiction
06/03/2002 ---IRB Winding Up
01/10/2007 ---IRB Withdrawal of Approval
09/02/2008 ---Is 1572 a Legal Contract
08/15/2007 ---Is 1572 Mandatory in Non-US Trial
05/04/2009 ---Is 1572 Necessary For Sub Study
01/03/2007 ---Is an IND Required if There is No Interstate Commerce Involved
01/30/2014 ---Is a PI e-Signature Required on Electronic ClinRO Records?
07/09/2007 ---Is Fasting Prior to Consent a Research-Related Activity
01/19/2007 ---Is Fasting Prior to Signing the ICF a Research Activity
06/30/2011 ---Is FDA Approval Required?
11/19/2013 ---Is Form FDA 1572 Required?
07/22/2002 ---Is GCP a Law?
09/30/2010 ---Is GCP the Law?
03/05/2008 ---Is ICD for Subjects or Sponsors
09/10/2010 ---Is ICH/E6 a Requirement for IRBs? Hot topic!
04/25/2013 ---Is IND Needed for Study of 2 Approved Drugs being used in Combination?
03/02/2012 ---Is IND Required for Generics Studies Intended for European Submission?
05/30/2016 ---Is it Compulsory to Meet Exact Number of Subjects to Be Randomized in the Study?
03/05/2008 ---Is One Study Enough
04/07/2014 ---Is Pregnant Partner a Research Subject?
10/23/2013 ---Is Registration of Expanded Access IND study on ClinicalTrials.gov required?
04/29/2011 ---Is Subject Initial Considered as Confidential Information?
01/31/2012 ---The Issue of Citizen
03/10/2012 ---The Issue of Citizen
02/16/2013 ---Is this a FOIA request?
09/01/2010 ---Is this an FDA Regulated Clinical Trial?
04/21/2009 ---Is This IVD Research?
01/27/2010 ---Is this legal?
05/22/2014 ---Is this Study FDA-Regulated?
10/03/2010 ---IT SOP
10/31/2012 ---IVD - Financial Disclosure Question
10/31/2012 ---IVD - Financial Disclosure Question
09/02/2008 ---IVD Device Study and Informed Consent
01/27/2004 ---IV mucomyst & Hydroxyprogesterone - medical Rx - IRB/IND needed?
02/08/2013 ---I was Curious what the Standard Definition of a Clinical Trial is
10/21/2014 ---IWRS as Unblinding Mechanism
04/22/2010 ---Jan 2009 Guidance on Reporting of Unanticipated Problems to Irbs
03/09/2006 ---JCAHO Accreditation
10/05/2007 ---Job Descriptions
03/03/2010 ---Just a Quick Question on Form 1571
09/22/2011 ---Keeping Scanned Copies of Consent Forms
08/11/2010 ---Kind Ask
12/21/2005 ---Kind Atten: Bonnie M. Lee
12/28/2009 ---Kindly Resolve This Case That Will Help Me
03/26/2009 ---Lab Abnormalities
07/19/2011 ---Lab AE
06/16/2003 ---Lab certification and 1572s
03/28/2007 ---Lab Change of Address
11/08/2011 ---Lab director CV and Med License - Are These Really Essential Documents
01/12/2009 ---Lab Document Retention
01/08/2014 ---Lab Drawing Stations
04/25/2006 ---Labeling Donor Tissues
11/21/2007 ---Labeling for Commercial Drugs Tested at New Dose
04/03/2003 ---Labeling Investigational drug for FDA-regulated clinical trial
09/03/2003 ---Labeling investigational drugs
11/09/2012 ---Labeling of Clinical Trials Specimens
12/16/2008 ---Labeling of Drugs- IND- Exempt Study
05/21/2014 ---Labeling of IMPs for BE studies
10/14/2009 ---Labeling of Investigational New Drug
11/20/2012 ---Labeling of Investigational Products
06/21/2011 ---Labeling of Source Documents and Subject Identifiers
12/04/2008 ---Labeling Placebos
11/12/2002 ---Labeling Requirements
07/25/2008 ---Labeling Requirements for Clinical Trial Drugs
11/13/2012 ---Labeling Requirements of Non-IP
04/24/2015 ---Labels for Investigational Products
02/06/2007 ---Laboratories Used for Clinical Trials
05/06/2008 ---Laboratories Used in Clinical Trials
12/12/2011 ---Laboratory
07/21/2009 ---Laboratory Accreditation
02/12/2008 ---Laboratory Certificate
04/21/2015 ---Laboratory Certification
02/05/2013 ---Laboratory Certifications
03/24/2009 ---Laboratory Certification with Protocol Amendments
11/20/2007 ---Laboratory Director's CV
05/01/2007 ---Laboratory Director CVs
12/30/2011 ---Laboratory document requirements
02/03/2010 ---Laboratory Practices
11/28/2006 ---Laboratory Records
05/30/2008 ---Laboratory Reference Ranges
11/07/2002 ---Laboratory Reports
09/18/2007 ---Laboratory Report Signature Question
08/10/2012 ---Laboratory Requirement for a Study under an IND
07/08/2010 ---Lab Reference Ranges & EDC
02/01/2012 ---Lab Results and AEs
03/06/2006 ---Labs Listed on Form 1572
10/03/2012 ---Labs on 1572 - Used only Once
02/26/2007 ---Labs that Are Included on the 1572
01/29/2009 ---Lack of Continuing Review Due to Administrative Error
08/08/2008 ---Lack of Documentation of Informed Consenting
08/09/2006 ---Lack of Medical History in Clinical Trials
11/21/2013 ---Language Barriers
05/31/2012 ---Language in Clinical Trial Agreement regarding Sponsor approving Sites Audit Response
06/15/2010 ---Lapse between Approval and Receipt of a Consent
04/04/2007 ---Lapse Between Expiration and IRB Renewal
04/03/2007 ---Lapse of IRB Approval
02/24/2014 ---LAR (Legal Authorized Representative) Query
12/21/2016 ---LAR, Caregivers, Guardian, Step Parents
04/21/2006 ---LAR Signature Line
09/05/2012 ---LAR with Informed Consents
02/20/2003 ---Last minute question
03/28/2012 ---Last Progress Note
09/21/2010 ---Late Reporting of SAEs
04/25/2013 ---Latest Change in ICH GCP Guidelines
04/25/2013 ---Latest change in ICH GCP guidelines
04/03/2007 ---Leftover or Returned Study Medication
01/28/2003 ---Legal Ages
07/21/2008 ---Legal Competency vs Decisional Capacity
06/02/2014 ---Legality, Validity and Compliance of Electronic Signatures
08/30/2012 ---Legally Acceptable Representative for Adolescent Subject
08/31/2010 ---Legislative Control on Clinical Trials and Compliance with GCP
08/02/2012 ---Length of Investigator's Brochure
03/03/2006 ---Length of Time to Archive Study Data
08/23/2011 ---Letter of Objections
08/19/2004 ---Letter Regarding Financial disclosure form
12/30/2008 ---Letter Sent to OHRP- Now Forwarded to OGCP- Pt. Safety and HIPPA Violations
06/05/2013 ---Levothyroxine
02/03/2012 ---Liability Question
11/04/2005 ---Life Threatening SAE
08/28/2003 ---Limitations on funding of investigator initiated research proposals
12/05/2010 ---Limits of IRB
04/09/2008 ---Lines in CRFs
05/14/2004 ---Link
06/10/2004 ---Link
02/09/2005 ---Link
10/16/2009 ---Link
06/16/2010 ---Link-Whether IND-IDE Needed
10/16/2009 ---Links
06/09/2006 ---Links to Financial Disclosure Regulations Guidance Documents
03/12/2003 ---Links to websites
06/25/2007 ---Link to Draft Guidance on Emergency Research Studies
06/25/2007 ---Link to Draft Guidance on Emergency Research Studies
01/07/2009 ---Link to Notice Withdrawing ANPRM
05/17/2005 ---Link to OHRP HSP Training
03/19/2010 ---Link to replies to previous queries
04/13/2004 ---Link to the Guidance for Studies Conducted Under 21 CFR 50.24
06/25/2007 ---Link to Webpage
10/16/2008 ---Listing 2 IRBs on 1572
03/02/2004 ---Listing IRB Assurance on FDA Form 1572
04/16/2002 ---Listing National Ethics Committees on FDA-1572
04/20/2010 ---Listing of clinical trial information on private websites
11/26/2003 ---Listing of FDA sanctioned resources
02/22/2005 ---Listing of Investigators Conducting Clinical Research
02/06/2009 ---Listing Pharmacist In Block6- 1572
09/01/2010 ---Listing Subinvestigators on 1572
03/24/2010 ---List of 483
02/02/2005 ---List of 5024 Studies
06/17/2010 ---List of Approved Trial Sites
11/13/2007 ---List of Elements to Include in a Clinical Quality Plan
09/15/2008 ---List Of Firms Who Have Been Fined
04/15/2010 ---List of GCP
11/16/2009 ---List of GCP Questions and Answers
05/28/2009 ---List of IRB's in [Redacted]
02/25/2015 ---List of Members Attending EC Meetings
07/29/2008 ---Lists of DQ Investigators
08/17/2011 ---Local Country Requirements vs. FDA Citation
11/23/2011 ---Local Institutional Approval
07/23/2007 ---Local Lab Listing on 1572
07/19/2011 ---Location
03/19/2010 ---Location of Proposed Regulation Changes
07/31/2006 ---Logos for Clinical Trials
05/03/2007 ---logs again
02/09/2011 ---Long-Term Follow-Up Question
09/25/2007 ---Long Term Follow-Up of Subjects in Closed Clinical Trial
02/17/2006 ---Long Term Storage of Medical Information-Source Documentation
03/27/2007 ---Long Term Study Subject Survival Follow-Up
02/05/2009 ---Looking for an In-State GCP Course
05/18/2010 ---Looking for Answer
07/23/2003 ---Looking for a site
04/15/2010 ---Looking for Clarification
10/26/2010 ---Looking for Information Sheet
03/26/2007 ---Loss of E-Data
01/16/2014 ---Lost Original Consent but have a Copy
02/27/2013 ---Lost Source Documentation (Medical Chart)
09/01/2011 ---Lost to Follow-up and PDF Documents
01/22/2015 ---Mailing/Emailing Consents
09/06/2011 ---Mailing Consent Form
05/07/2008 ---Mailing of Study Investigational Drug to a subject...
09/04/2007 ---Mailing Re-Supply of Study Drug
05/16/2013 ---Maintaining Annual IRB Approvals for FDA Protocol
01/08/2004 ---Maintaining Certification
09/24/2013 ---Maintaining Data Timelines
02/28/2006 ---Maintaining Records When No Subjects Are Enrolled
08/20/2012 ---Maintaining Regulatory Documents for Auditing
06/07/2005 ---Maintaining Rough Copies
11/26/2002 ---Maintaining the Blind
11/20/2007 ---Maintenance of Images
12/14/2005 ---Maintenance of Records at Trial Site
07/12/2010 ---Maintenance of Study Records in Paper Form
08/23/2006 ---Maintenance of Training Documentation for Computer Systems
12/11/2015 ---Making Corrections
12/11/2015 ---Making Corrections
04/28/2008 ---Making Corrections in Documents
11/12/2003 ---Management of Study Medications
03/06/2015 ---Mandatory Banking for Future Unspecified Research
02/15/2012 ---Mandatory Reporting
10/08/2002 ---Manufacture of GCP drugs
05/02/2014 ---Market Research during Clinical Trial Phase
06/12/2014 ---Master Personnel Lists
01/27/2005 ---Masters
01/13/2005 ---Maximum Percentage of Patient Data Acceptable to FDA
09/23/2010 ---May 2010 1572 Guidance
12/03/2008 ---May a Sponsor Sue Email to Notify FDA of Fatal or Life-Threatening Adverse Events
01/12/2006 ---May Site Staff Participate in Study
11/08/2011 ---May we rely on the HR Credentialing Office to obtain/maintain proof of current and ongoing licensure/registration for investigators?
03/22/2012 ---MBA Student looking for Information regarding GXP Auditing
06/22/2016 ---MDR of Events that Occurred during Clinical Trials
09/02/2015 ---MD vs. APN Investigators
06/19/2003 ---MD vs nonMD as PI
04/11/2005 ---Meaning of All Participating Investigators
01/20/2015 ---Measurements on PROs
06/28/2007 ---Med Care for Subjects
02/08/2008 ---Media Release from Sponsor
02/08/2008 ---Media Release from Sponsor
02/08/2008 ---Media Release from Sponsor
03/07/2012 ---Medical Device/IVD Clinical Trials using Foreign Sites
04/10/2006 ---Medical Device Approval Advice Needed
01/09/2012 ---Medical Device GCP AE/MDR Question
08/30/2007 ---Medical Device Question
04/03/2008 ---Medical Device Research
04/05/2011 ---Medical Devices
06/14/2012 ---Medical Device Trials: FDA 1572 + Financial Disclosure versus Investigator Agreement
05/17/2007 ---Medical Files of Subjects
09/07/2007 ---Medical History Collection
07/24/2009 ---Medical History in Clinical Trials
07/24/2009 ---Medical History in Clinical Trials
03/11/2013 ---Medical History Records & Drug Accountability
06/29/2007 ---Medical History to Determine Eligibility
08/11/2008 ---Medical History Verification
10/03/2002 ---Medical License?
05/24/2007 ---Medical License Question
10/14/2016 ---Medical License vs. Board Certification
04/23/2003 ---Medical Malpractice
05/11/2003 ---Medical Monitor
06/22/2006 ---Medical Monitor
06/23/2014 ---Medical Monitor/Medical Expertise - Qualification Requirement
12/04/2013 ---Medical Monitor in a Clinical Trail
04/26/2006 ---Medical Monitoring and Degreed Personnel
02/06/2013 ---Medical Monitor Q
10/10/2008 ---Medical Monitor Qualification Questions
02/23/2004 ---Medical Monitor Question
02/23/2004 ---Medical Monitor Question
02/04/2008 ---Medical Monitors
01/24/2003 ---Medical Monitors and Conflict of Interest
11/07/2002 ---Medical Records
11/20/2007 ---Medical Records
03/05/2008 ---Medical Records
11/08/2011 ---Medical Records
02/28/2008 ---Medical Record Screening
02/28/2008 ---Medical Record Screening
10/05/2011 ---Medical Records Request
12/02/2011 ---Medical Records Translation
11/15/2007 ---Medical Records vs. Medical History
04/25/2012 ---Medical Safety Monitor
09/17/2004 ---Medical Screening Period
09/02/2005 ---Medical Waivers During Clinical Trials
03/23/2011 ---Medication Administration
02/24/2009 ---Medication Changes and Testing Prior to Screening
03/25/2011 ---Medication Safety Issue-Investigational Drugs
07/01/2010 ---Medication Usage
09/15/2010 ---Medicinal Test (or Pre-Clinical Trial) in Animal
03/06/2008 ---MedWatch Reporting
05/29/2014 ---Meeting Minutes
11/04/2004 ---Meeting Questions
01/24/2008 ---Meetings With CIs
04/30/2008 ---Member Conflict
08/31/2005 ---Membership on IRB
08/13/2009 ---Memory Aids
03/10/2008 ---Memos to File
01/11/2008 ---Message
03/08/2010 ---Message for [Redacted]
09/03/2015 ---Message from Unknown sender [Redacted] - Investigator Record Retention
06/24/2008 ---Meta-Analysis Guidelines
09/15/2010 ---Method of IRB Approval/Question What Constitutes FB Approval
09/27/2002 ---Microfilming Study Records
07/03/2013 ---Microsort Clinical Trial
02/22/2016 ---Midlevel Clinicians' Scope of Practice on Clinical Trials
11/17/2010 ---Minimal risk non-drug non-device dissertation question
04/29/2008 ---Minimum Info on Screened Subjects
04/29/2008 ---Minimum info on screened subjects
07/25/2007 ---Minimum Requirements for CRC
10/04/2016 ---Minor Protocol Deviations and IRB Review
02/08/2010 ---Misbranding in Clinical Trials
09/04/2007 ---Missed Informed Consent Question
09/23/2011 ---Missed Screening Activity
03/08/2007 ---Missing Data
08/20/2008 ---Missing Followup Letter
09/13/2012 ---Missing Subject Source Charts
05/21/2010 ---Missing Unbilnding Envelope
12/27/2012 ---Mission is taking Flight
07/25/2003 ---Mistake in Clinical Trial
01/30/2014 ---Mobile Chemotherapy
08/19/2013 ---Modified 50.25 c Language
03/15/2006 ---Monetary Payments to Clinical Investigators
11/21/2006 ---Monitor-Subject Contract
12/04/2015 ---Monitor Area for Record Review
04/11/2014 ---Monitor Assistance with Completing Study Tracking Logs
05/02/2014 ---Monitor Assistance with Completing Study Tracking Logs
05/30/2008 ---Monitoring
11/06/2013 ---Monitoring, Auditing and Reviewing of Clinical Trials
10/30/2008 ---Monitoring by Sponsors
08/01/2006 ---Monitoring Compliance Questions
05/12/2011 ---Monitoring Guidance Document
08/08/2011 ---Monitoring Informed Consent Forms
09/21/2011 ---Monitoring Investigators in Clinical Trials
10/30/2014 ---Monitoring IP Storage Temperature
09/08/2013 ---Monitoring manual
03/07/2006 ---Monitoring of Phase 1 Studies
04/21/2003 ---Monitoring reports
07/03/2011 ---Monitoring Reports
06/26/2013 ---Monitoring Requirements for Post-Marketing Studies - Minimum Requirements
03/05/2013 ---Monitoring Visit at Non-enrolling Clinical Study Site
06/25/2004 ---Monitoring Visit F/Up Letters
06/03/2011 ---Monitoring Visit Log in Clinical Trial
12/02/2009 ---Monitoring Visit Question
06/03/2010 ---Monitor Interpreting Data
11/06/2007 ---Monitor Training
07/07/2006 ---Monitor Training Records
02/23/2009 ---Monitor Witnessing Study Procedures
06/21/2006 ---Monitory Directly Contacting Subject
08/22/2011 ---More Information
02/20/2003 ---More Questions
04/14/2011 ---Most Recent 1572
04/19/2011 ---Most Recent 1572 Form
09/16/2010 ---MOU re Brazil GCP Inspections
08/04/2015 ---Moving to eTMF - Request for Guidance on 1572 Originals
05/31/2013 ---MRI Technician Qualifications
04/11/2002 ---ms
03/06/2014 ---MS Word Document as Source
02/21/2008 ---Multinational Trials and 1572s
02/19/2004 ---Multiple 1572 Questions
03/23/2004 ---Multiple 1572s for the same study
05/11/2015 ---Multiple Contracted IRB's/Protocol
05/12/2015 ---Multiple Contracted IRB's/Protocol
10/28/2009 ---Multiple IRBs- FDA1572
04/03/2015 ---Multiple Questions
05/19/2008 ---Multisite Studies and Principal Investigators
05/28/2014 ---Multi Specialty Group of Physicians
12/23/2003 ---Must a Form FDA 1572 be Used?
03/26/2008 ---Must ICD Contain Fin Disc Info
07/29/2009 ---Must IRB Reveal Membership List
10/06/2008 ---Must NonUS Protocol Differ From US Protocol
10/14/2008 ---Must Payments to Subjects Be Reported to IRS
07/24/2008 ---Must Subject's Medical Records be Obtained
12/29/2008 ---My GCP Question
04/06/2010 ---My Health
01/21/2016 ---My Invention
06/08/2006 ---My Monitors Contact Subjects
02/08/2010 ---Name disclosure on Informed consent document question
11/19/2002 ---Named person
01/24/2013 ---Nano-Technology products
02/15/2011 ---Narratives for Adverse Dropouts in the CSR
09/27/2013 ---NCI Website References in Consents
08/13/2008 ---NCT Identifier
10/27/2015 ---NCT Locations
10/22/2008 ---Necessary Qualifications
03/25/2005 ---Necessity to Notify Investigators of SAEs
01/18/2011 ---Need Clarification and Guidance
07/27/2005 ---Need Clarification of ICH Guideline 8.3.14
04/04/2013 ---Need Confirmation
11/24/2009 ---Need for 1572- 2nd Protocol
07/22/2005 ---Need for a Data Safety Monitoring Board
07/14/2009 ---Need for GCP Certification
10/21/2008 ---Need for IND and IDE
03/26/2010 ---Need for IRB Reapproval for Drug Coming Off Hold Status-Redacted
10/22/2008 ---Need for Subjects Medical Records
04/07/2008 ---Need GCP Materials
12/21/2005 ---Need Guidance/Advice on Developing a Web-Based Consent Document
06/25/2002 ---Need info
03/23/2010 ---Need Information
08/30/2010 ---Need Information
02/01/2012 ---Need Opinion
11/13/2003 ---Need some knowledge
05/10/2002 ---Need the GCP
03/29/2010 ---Need your Kind Opinion
01/19/2011 ---Need your Kind Opinion
10/13/2006 ---Need Your Opinion
01/21/2012 ---Need Your Opinion
01/11/2011 ---Network Trial 1572
04/11/2013 ---New 1572 Form
04/19/2013 ---New 1572 Form
05/02/2012 ---New 1572 Form dated 2/12
09/08/2013 ---New 1572 Template versus Former 2 Page Format
06/05/2012 ---New CI
04/09/2002 ---New drug application process
04/23/2013 ---New Electronic Version of the 1572 with Glitches - Can a Sponsor Still Use the Older pdf Version
09/07/2012 ---New FDA1572
07/25/2012 ---New FDA 1572 Form
12/21/2011 ---New FDA Rules for Clinical Investigator Compliance
09/27/2012 ---New Format for 1572
08/26/2002 ---New GCPs
03/09/2012 ---New Informed Consent Requirements, 21 CFR § 50.25(C) - Query
10/24/2006 ---New Part 11 Re-Write
07/01/2008 ---New Policy for Adverse Events and Unanticipated Problems
12/21/2011 ---New Required Informed Consent Language
11/30/2007 ---New Research Model
04/15/2011 ---New Research Site. CRC with Some Questions
10/25/2006 ---New Safety Information Question
01/09/2007 ---News Articles Versus Advertisements for Recruitment
05/13/2010 ---New Side-Effects Detection System - Question
06/10/2005 ---Newsletter
06/23/2003 ---New Trial Question
08/05/2010 ---New Version of the 1572 Available on the ctep.cancer.gov Website?
08/05/2010 ---New Version of the 1572 Available on the ctep.cancer.gov Website?
07/20/2016 ---NIAID
11/10/2009 ---Nicotine Vaccine
11/24/2015 ---NIH HSP Training
07/16/2003 ---NIH INDs
10/27/2004 ---NIH Regulation
12/19/2006 ---NIH Sponsored Trials
02/22/2005 ---Non-Clinical Personnel Site Visits
04/09/2009 ---Non-Compliance Questions
06/26/2012 ---Non-Conflicting Studies
08/20/2003 ---Non-English consents
01/22/2010 ---Non-English Speaking Patients
11/05/2012 ---Non-English Speaking Subject at a Foreign Site
08/13/2012 ---Non-GCP Compliant Data Questions
09/10/2007 ---Non-IND Medwatch Form
07/16/2010 ---Non-IND Record Retention
06/28/2011 ---Non-licensed Principal Investigators
10/01/2007 ---Non-Licensed Study Personnel
10/25/2006 ---Non-Physician Investigators
05/30/2013 ---Non-Scientist Definition
06/15/2005 ---Non-study SOP Deviations
03/29/2016 ---Non-Study Specific Advertising
02/06/2009 ---Non-US Investigators- FDA 1572 Form
05/19/2012 ---Non-US Investigators conducting INDs
12/30/2008 ---Non-US IRB
02/06/2009 ---Non-US Sites and FDA 1572 Form
06/28/2012 ---Nonclinical Lab Study
04/22/2010 ---Non Compliance by Patient as Protocol Deviation
10/18/2010 ---Noncompliance Issue/Reportable
06/19/2009 ---Nondiscrimination-Civil Rights Laws Apply to Subject Clinical Studies
01/19/2010 ---Non Face to Face IC Process
10/29/2007 ---Non MDs as Clinical Investigators
10/22/2004 ---Non NIH-Funded COC Applicants
04/18/2006 ---Non US Studies
06/25/2010 ---No Response Present
04/21/2015 ---No Safety Net for Humans in Clinical Trials
11/30/2006 ---No subject
08/22/2013 ---No Subject
07/26/2010 ---Notes to File
03/21/2005 ---Notice of meeting regarding IRBs and adverse event reporting
10/22/2014 ---Notification of Protocol Deviations to FDA
03/14/2007 ---Notification of Suspect Serious Unexpected Adverse Reactions Time Lines to Investigators
04/01/2011 ---Notification Regarding an IND
03/04/2008 ---Notification Re Termination of a Study
11/18/2003 ---Notification to FDA
10/25/2012 ---Notification to Primary Care Physician
09/04/2008 ---Notifying FDA About CI Noncompliance
05/08/2012 ---Notify of Study Termination
03/29/2005 ---No title.
08/22/2006 ---November Workshop
06/03/2015 ---NSR/SR Designation
08/26/2013 ---NSR Determinations
04/22/2009 ---Numbering Pages -Blanks In Records
06/19/2009 ---Number of 1572s to Sign
10/08/2015 ---Number of IRB, CI & Sponsor Inspections in Calendar Year 2014 And 2015
11/03/2015 ---Number of IRB, CI & Sponsor Inspections in Calendar Year 2014 and 2015
11/05/2015 ---Number of IRB, CI & Sponsor Inspections in Calendar Year 2014 And 2015
12/06/2011 ---Number of Phase I Trials
09/20/2004 ---Number of trials per C.R.A
02/01/2010 ---Numbers of Approved Clinical Trials
02/01/2010 ---Numbers of Approved Clinical Trials
02/24/2014 ---Nurse Practitioner in FDA 1572
12/18/2007 ---Nurse Practitioner Role in Clinical Research
12/13/2013 ---Nurse Practitioners
01/28/2009 ---Nurse Practitioners as Clinical Investigators
04/06/2009 ---Nurse Practitioners as Sub Investigators
09/22/2010 ---Nurse Practitioners Role in Clinical Trials
01/31/2014 ---Nurses/Non-Nurses Distributing Study Drug
03/05/2013 ---OAI and IRB review
12/21/2005 ---Observational Studies
02/12/2008 ---Observational Study 1572
08/04/2016 ---Obtaining Consent from Non-English Speaking Subject
12/30/2009 ---Obtaining Medical Records for Participants in Clinical Trial
11/17/2008 ---Obtaining Medical Records for Subjects in Research Studies
07/24/2008 ---Obtaining Subject's Medical Records
04/25/2006 ---Obtaining Subjects Files
08/13/2009 ---Obtaining Urine Samples for Biomarker Study
11/02/2002 ---Off-label use
07/14/2008 ---Off-Label Use Being Marketed Being Used in Scalable Treatment Protocols by Affiliated Medical Practices
09/11/2012 ---Off-Label Use of HUDs
11/23/2005 ---Off-label use question
09/03/2013 ---Off-Site Backup
04/13/2009 ---Off-Site Record Storage
05/19/2004 ---Off-Site SAE Review for Multicenter Trials
05/21/2004 ---Off-Site SAE Review for Multicenter Trials (2)
11/12/2010 ---Office of Good Clinical Practice
02/20/2015 ---Official Identification for Clinical Subjects
01/22/2010 ---Offsite Storage
03/22/2010 ---OGCP work
10/14/2005 ---OHRP's New Guidance Document on AE/Unanticipated Problems Reporting
10/05/2008 ---OHRP Guidance vs. FDA Guidance
05/19/2005 ---OHRP vs. FDA GCP guidelines
06/07/2005 ---OHRP vs. FDA GCP guidelines
06/27/2013 ---Omnibus Rule
10/10/2012 ---On-Site Training on GCP
11/04/2011 ---Oncology Trial
10/21/2009 ---One More Question Re Financial Disclosure
12/08/2009 ---One or More IRBs
08/23/2012 ---Online 1572 Form
04/09/2012 ---On Line Class on GCP
04/11/2002 ---Online courses on GCP?
04/29/2009 ---Online GCP Course
03/15/2012 ---Online GCP Course
01/29/2013 ---Online GCP training
02/04/2014 ---Online GCP Training?
10/10/2007 ---Online GCP Training for New Principal Investigators and Staff
06/24/2010 ---Online Training
12/30/2011 ---Online Training
01/26/2015 ---Online Training
01/24/2011 ---Online Training for PIs
05/21/2008 ---Only One Study Required for Substantial Evidence
09/25/2015 ---Onset Time for Recording of Adverse Events in Clinical Studies of an Investigational Product
09/16/2014 ---On Site GCP Training
08/22/2012 ---Onsite IRB vs. IRB of Record for a Study
09/18/2012 ---On Site Pregnancy Testing
02/02/2016 ---Open Access to Genetic and Health Information as described in the NCI IC Template
10/26/2010 ---Open Label Extension and Blind Protection
02/08/2008 ---Open Label Studies
10/05/2004 ---Open Label Studies to Measure Patient-Reported Outcomes
09/25/2008 ---Open Studies
04/14/2015 ---Operational Accidental Unblinding
04/14/2015 ---Operational Accidental Unblinding
12/23/2008 ---Opt-In, Opt-Out Options in Informed Consent Documents
08/13/2015 ---Optional Informed Consent Signature
08/14/2014 ---Optional Procedures in a Clinical Trial
05/06/2008 ---Oral Orders To Administer Test Article
04/24/2013 ---Organ Donation.
01/21/2016 ---Original and Copies of Documents in the Investigator Site File and the Trial Master File
12/06/2011 ---Original Document of IRB Approvals, Kept at Site or at Sponsor
05/15/2014 ---Original Documents for IND Submission
05/14/2010 ---Original Informed Consent Document
03/27/2013 ---Original or Scanned Documents
06/17/2009 ---Original Record(s) Custody
05/29/2013 ---Original Records
05/09/2008 ---Original Scanfilms to be Obtained by Study Site
05/19/2009 ---Original Signature on Form 1571
02/15/2011 ---Original Signatures vs Scanned Signatures
01/23/2014 ---Original Signature Vs Scanned Signature on Study Document
09/22/2008 ---Originals of Scanned Documents
08/11/2006 ---Original Versus Copy of Study Documents
05/13/2016 ---Origins of GCP in the US
04/01/2009 ---Orthopedic Devices for Hips and Knees
03/10/2014 ---OSI Reports Previous Years
05/20/2016 ---OTC Pregnancy Test used in Clinical Research
03/01/2007 ---OTC Switch Studies and GCP
09/13/2010 ---Other Manufacturer Notification of Serious Adverse Events
03/11/2009 ---OUS Clinical Trials
10/23/2009 ---Out-of-Window Visit Calculations
04/13/2005 ---Outdated 1572 form
05/08/2009 ---Outside Agency Following Up with Subjects
05/14/2009 ---Outside Agency to Follow Up with Subjects
10/31/2006 ---Outside Laboratories
10/31/2006 ---Outside Laboratory Documentation
11/29/2012 ---Outsourcing Services
04/19/2011 ---Over-Enrolled Subject Data Use
10/01/2008 ---Overnight Stays Involving Human Subjects
03/25/2002 ---Overseas GCP
03/10/2015 ---Oversight of IRB Submissions
05/29/2013 ---Oversight of Sponsor vs CROs
06/14/2013 ---Oversight of Sponsor vs CROs
04/25/2007 ---Oversite of Satellite Clinical Sites
03/20/2013 ---Packaging and Adherence Information
03/20/2013 ---Packaging and Adherence Information
05/09/2006 ---PAHO Good Clinical Practices Document of the Americas
04/11/2013 ---Paper Source Documents to Electronic
03/28/2013 ---Paper to EHR
02/20/2008 ---Paper Versus Paperless System
11/29/2005 ---Parallel track drugs
11/29/2005 ---Parallel track drugs
12/13/2004 ---Parental Permission and Possible Waiver for Use of [Redacted]
11/24/2009 ---Parent Who is Minor Consenting for Child
06/26/2003 ---Part 11
05/08/2015 ---Part 11 and Sponsor-Investigator Trials
04/01/2004 ---Part 11 Compliance-Electronic Records, Electronic Signatures
01/04/2016 ---Part 11 compliance/Closed System vs. Open System
02/16/2005 ---Part 11 Compliance of open systems
02/02/2007 ---Part 11 GCP Question Electronic Signature
02/02/2007 ---Part 11 Issues IEC Communications
03/09/2006 ---Part 11 Question
02/26/2016 ---Part 11 Question - Important
01/08/2007 ---Part 11 Question Audit Trails
06/25/2002 ---Part 11, and GCP guidance
02/09/2009 ---Partial Withdrawal
06/09/2015 ---Participants in Investigational Drug Studies
10/28/2009 ---Participating in Clinical Trials
11/29/2013 ---Participation in a Clinical Trial of Investigator's Relatives
08/26/2009 ---Participation in Clinical Trial of Non-English Speaking Person
05/28/2014 ---Participation in more than One Trial
06/21/2008 ---Participation in Multiple Studies
12/10/2008 ---Participation in Multiple Studies
07/31/2007 ---Participation Of Relatives or Staff in Trials
01/28/2013 ---Part time investigators and Form 1572
12/20/2016 ---Past Medical Records Question
10/26/2010 ---Patient / Investigator Access to Study Data for Post Study Treatment
06/19/2009 ---Patient Being Denied Entry Into IND-1
01/23/2008 ---Patient Clinical Samples and Retention
06/19/2007 ---Patient Compensation and Injury
06/21/2002 ---Patient Compliance Programs and FDA Approval
06/29/2007 ---Patient Consent- Pregnancy Data Collection
04/30/2003 ---Patient Consent Form
09/24/2012 ---Patient Contact Information (Telephone) on ICF
07/12/2011 ---Patient De-Identification
07/29/2011 ---Patient Diary Entry Question/Clarification
11/24/2010 ---Patient Enrolled in Two Clinical Trials Concurrently
03/05/2007 ---Patient Identifier Question
03/27/2007 ---Patient Information
09/23/2002 ---Patient Informed Consent
08/22/2011 ---Patient Questionnaires
09/11/2012 ---Patient Reach Out Program
01/04/2005 ---Patient Record Privacy Requirements
06/02/2009 ---Patient Records
05/27/2009 ---Patient Recruitment
11/21/2012 ---Patient Recruitment for Clinical Trials in Developing Countries
11/18/2005 ---Patient Recruitment Question
08/21/2008 ---Patient Research Chart and Protocol
09/05/2003 ---Patient responsibility
04/07/2006 ---Patient Retention Campaign on a Long-Term Study
07/06/2010 ---Patient Safety and Well Being for the Subject in Clinical Trials
11/09/2014 ---Patient Safety Assessment
03/03/2003 ---Patient screening logs
04/25/2008 ---Patients Developing Dementia
07/12/2012 ---Patient Specimen Retention
12/22/2016 ---Patient vs. Subject
09/07/2004 ---Patient Withdrawal
07/13/2007 ---Paying for Study Drug
06/25/2007 ---Payment- Subject Referrals
11/27/2007 ---Payment for Time and Office Visit of Study Participants
04/10/2008 ---Payment From Subjects
07/24/2003 ---Payment of clinical trials subjects
10/15/2007 ---Payments and Speaking Fees
10/22/2008 ---Payments for PI Meetings
08/14/2008 ---Payments from Pharm Cos
03/27/2008 ---Payments to Clinical Investigators and Their Staff
09/03/2002 ---Payments to Principal Investigators (PIs) and Site Management Organizations (SMOs)
07/10/2006 ---Payments to Subjects
04/16/2007 ---Payments to Subjects
06/11/2008 ---Payments to Subjects
06/04/2013 ---PDF Versions of ICH/GCP, ISO 14155
11/07/2007 ---Pediatric Blood Draws
04/17/2003 ---Pediatric Clinical Trials
02/24/2015 ---Pediatrician Required for Subjects of 16- 17 Yrs Age
06/27/2007 ---Pediatric Research
02/04/2007 ---Pediatrics Pregnancy Question
10/25/2011 ---Pediatric Trial
12/01/2008 ---Pediatric Vaccine Trials vs. Drug Studies - Reg Requirements
10/29/2009 ---Peramivir IV Use
04/17/2008 ---Permission from Sponsor
05/28/2002 ---Permission to use information in a local publication
01/25/2008 ---Personal Databases
06/21/2011 ---Personal Laptop Use for Source Document Generation
12/05/2016 ---Person Obtaining Consent Inquiry
02/19/2004 ---PERU
07/13/2009 ---Pharmaceutical Communication With Sponsors
09/22/2014 ---Pharmaceutical Company Requirements for Licensed MDs
09/22/2014 ---Pharmaceutical Company Requirements for Licensed MDs
09/22/2014 ---Pharmaceutical Company Requirements for Licensed Mds 2 and 3
07/07/2009 ---Pharmaceutical Sponsor Payments to Principal Investigators
09/09/2002 ---Pharmacist on the IRB Committee
02/04/2008 ---Pharmacists
06/27/2005 ---Pharmacists and Conflicts of Interest
12/02/2013 ---Pharmacogenomics Research and Promoting its Clinical Research-Financial Arrangements
11/27/2012 ---Pharmacokinetic Sub Study Informed Consent
07/07/2014 ---Pharmacy and Laboratory Temperatures
05/09/2008 ---Pharmacy Role in Clinical Trials
04/12/2010 ---Pharma Industry Discussion Regarding Digital Versus Electronic Signatures
02/04/2008 ---Pharm Comp Question
02/16/2007 ---Phase 1 Research Projects
06/24/2008 ---Phase 1 Studies
09/05/2013 ---Phase 1 Studies conducted outside of US
08/25/2013 ---Phase 1 Study for a Pediatric Drug
07/20/2010 ---Phase 1 Trial Requirements
09/29/2008 ---Phase 3 Trials For Hep C
01/20/2006 ---Phase 3b and 4 Monitoring
08/22/2006 ---Phase 4
07/17/2012 ---Phase 4
08/22/2006 ---Phase 4 Studies
01/21/2010 ---Phase 4 Studies
08/28/2006 ---Phase 4 Studies (FU)
11/25/2002 ---Phase 5 studies.
05/10/2005 ---Phase I Clinical Trials
10/13/2009 ---Phase I Clinical Trial Units In [Redacted]
02/18/2009 ---Phase II and III Clinical Trials
09/27/2012 ---Phase IIa vs. IIb Clinical Trials
01/30/2014 ---Phase III Clinical Trial - Enrollment Question
09/20/2012 ---Phase III Clinical Trials
09/23/2012 ---Phase III Clinical Trials
10/04/2007 ---Phase III Study
08/14/2010 ---Phase I Research Facilities
11/01/2012 ---Phase I Screening Consent
07/01/2015 ---Phase I Study, ClinicalTrials.gov ICF Language
05/14/2003 ---Phase I trials
08/31/2005 ---Phase IV clinical trials
07/29/2005 ---Phase IV Studies
08/01/2005 ---Phase IV Studies
02/17/2011 ---Phase IV Studies
09/25/2008 ---Phase IV Study Protocol on Previous Studies
03/27/2007 ---Phase IV Surveillance
05/09/2008 ---Phase of Clinical Trials
03/05/2007 ---Phase One
11/26/2013 ---Phase One Question
04/22/2009 ---Phase One Units
11/30/2009 ---Phases of a Clinical Trial
05/07/2008 ---PhD Clinical Investigators
02/18/2013 ---PHI and Study Records
06/11/2015 ---PHI Entered into EDC
07/12/2003 ---Phlebotomy in Clinical Investigations
06/26/2008 ---Phone Call Consent
01/09/2015 ---Photo ID and Screening
03/24/2008 ---Photos Of Subjects
01/20/2011 ---Physical Assessments
04/30/2010 ---Physical Disposition of a Ds office
08/29/2014 ---Physician-Investigator Dual Role
10/18/2007 ---Physician Assistants
12/08/2009 ---Physician Enrollment
04/24/2010 ---Physician Involvement in Clinical Trials Question
09/04/2008 ---Physician Payments
11/06/2013 ---Physician Question about Clinical Trial Records
03/18/2003 ---Physician Referrals
03/18/2003 ---Physician referrals
04/02/2014 ---Physician Referrals
05/30/2012 ---Physician Requirement for HUD Use
05/30/2012 ---Physician Requirement for HUD Use
06/13/2012 ---Physician Withdrawal of Patient from Study
11/17/2015 ---PI's/SubI's Entering Causality Data Directly into EDC
11/18/2015 ---PI's/SubI's Entering Causality Data Directly into EDC
01/23/2007 ---PI- Remote Sites
07/15/2014 ---PI Access of EMRs to Assess AEs for Subjects Discontinued from IP; PI Seeking Contact Info from Friends/Family for Subjects Lost to Follow Up
12/03/2013 ---PI Authorization and GCP Compliance
07/28/2014 ---PI Conflict in Dual Role as Health Authority Employee
10/13/2011 ---PI CV
09/23/2008 ---PI Delegation of Duties
11/19/2014 ---PI Duties
05/05/2015 ---PI Eligibility
10/07/2011 ---The PI Enter the "Date" For the Subject's Signature in ICF
01/18/2006 ---Pilot Studies
04/14/2009 ---Pilot Study
11/13/2015 ---PI or SI Signature on Protocol
11/13/2015 ---PI or SI Signature on Protocol
07/05/2015 ---PI Oversight
12/20/2011 ---PI Oversight Question
07/19/2012 ---PI Oversight Responsibilities for Homecare Nurses Performing Clinical Trial Tasks
03/27/2013 ---PI Qualifications
01/17/2007 ---PI Question
12/15/2014 ---PI Responsibilities
11/26/2008 ---PI Responsibility
11/01/2013 ---PI Retirement / Site Closure
05/31/2012 ---PI Sabbatical Coverage
01/25/2007 ---PI Signature on Adverse Event Reports
07/28/2016 ---PI Signature on CSR Requirements from Guidance for Industry
04/15/2011 ---PI Signature on Lab Report
02/04/2010 ---PI signature page in Investigator Brochure or Report of Prior Investigations
10/28/2016 ---PI Specialty
09/12/2007 ---PI Sub-I
08/28/2012 ---PI Subject Signoff at End of Study
04/30/2015 ---PI Wants to Resign from a SMO because of Noncompliance
12/27/2012 ---PI with Bachelor of Dental Surgery
05/07/2003 ---Placebo-controlled trials
03/30/2011 ---Placebo Controlled Studies
10/18/2006 ---Placebo Controlled Trial
01/11/2010 ---Placebo Run In and Deception
07/27/2012 ---Placebo use in Clinical Research with Children
11/16/2010 ---Place Security Finding
07/28/2016 ---Placing an Elective Administrative Hold for Training of New Staff
08/13/2014 ---Planned Deviation
03/02/2011 ---Please Assist with Question
08/04/2014 ---Please Comment: CRA previously as Study Coordinator
05/15/2013 ---Please Help!
11/23/2013 ---Please Help Me with Possible Meaning of FDA "Approved" 'Controlled Clinical Trial'
07/23/2014 ---Please Help Us Find the Best Path to FDA Approval of Our Anti-Cancer Agent
02/01/2006 ---Please Provide Us with the Details
12/15/2013 ---Please Respond - National History Day Interview (Topic: Clinical Research and the Study of Human Subjects)
07/23/2013 ---Point-of-Care Device Interfacing in Clinical Trials
06/11/2012 ---Point of Clarification: Regarding Reconsenting
01/23/2003 ---Policy
10/22/2007 ---Policy Clinical Labs
04/25/2006 ---Policy on Charging Patients
03/30/2011 ---Policy Question Social Media Use in Clinical Trial Patient Recruitment
08/03/2007 ---Possible Conflict of Interest
08/31/2007 ---Possible Double Payment of Expenses
11/02/2009 ---Post-Dating a 1572
08/19/2008 ---Post-Market Study - Consent IRB Requirements
08/21/2008 ---Post-Market Study - Consent IRB Requirements-2
04/03/2008 ---Post 2005 GCP E-mails
04/21/2015 ---Post FDA Inspection of Clinical Site
05/09/2006 ---Posting of Inclusion Exclusion Criteria
04/07/2015 ---Post marketing Adverse Event Reporting
06/22/2012 ---Post Marketing Adverse Events
05/31/2007 ---Post Marketing Survey
02/09/2012 ---Post Market Medical Device Regulations
06/13/2010 ---Post Study AE, Unanticipated Problem Reporting
09/17/2010 ---Potential Conflicts of Interest
06/20/2005 ---Potential Investor
03/25/2009 ---Potential Research Criteria
05/31/2011 ---Potential Subjects Fasting Prior to Written Consent
09/17/2002 ---Practical use of CCT guidance
08/26/2016 ---Pragmatic Trials
11/23/2014 ---Pre-Clinical and Clinical
06/06/2006 ---Pre-Clinical Studies Using Human Tissues
07/24/2009 ---Pre-consent
05/02/2012 ---Pre-Screening and Protocol Design
09/23/2004 ---Pre-Study / Initiation Visit Attendance Log
12/21/2011 ---Preambles
04/24/2008 ---Pregnancies of Female Partners of Male Subjects
04/10/2002 ---pregnancy and human studies
02/08/2008 ---Pregnancy as Adverse Event; AE before Randomization
06/09/2009 ---Pregnancy During a Clinical Trial
04/10/2006 ---Pregnancy Follow-Up
09/18/2007 ---Pregnancy Test Before IC
04/19/2013 ---Pregnant Partner Consent
03/04/2009 ---Pregnant Partner of Subjects
03/14/2015 ---Pre Initiation Visit
04/21/2011 ---Pre Market Application
06/06/2002 ---Preparation of IRB SOPs by the Institution
06/12/2013 ---Preparatory to Research
01/14/2011 ---Preparatory to Research - HIPAA
10/28/2013 ---Prescribing IP
02/13/2009 ---Preservation of Study Related E-mails
08/04/2008 ---Pressure from IRB Chair
09/05/2006 ---Previous FDA Inspection
02/17/2009 ---Previous Medical History Records
11/04/2004 ---PRIM&R Meeting Questions
03/10/2014 ---Primary Care Physician - IRB Approval Required?
06/06/2013 ---Primary Care Physician Notification
08/05/2004 ---Primary responsibility for GCP training at a sponsor
02/24/2010 ---Principal Investigator
11/30/2016 ---Principal Investigator (PI) Oversight/Participation in an Observational Study
02/17/2015 ---Principal Investigator as the Chairman of IRB
05/03/2011 ---Principal Investigator Question
12/05/2012 ---Principal Investigator Supervision
05/29/2007 ---Principal Investigator Unavailability
06/25/2007 ---Principle Invesitgator- Can He be a Pharmacist
10/08/2012 ---Principle Investigator CV
05/24/2016 ---Principle Investigator on Clinical Trial Agreement Document and IRB Documents
12/11/2013 ---Printed Copies of EMR
02/01/2011 ---Printed Medical Records as Source
08/24/2012 ---Printing Emails
02/15/2007 ---Printing of Clinical Trial E-Mail Correspondence
06/17/2009 ---Print Material
10/03/2006 ---Prisoners - FDA Regulated Study
04/08/2010 ---Prisoners as Subjects in Research
11/21/2007 ---Prisoners in Clinical Trials
10/09/2011 ---Private Health Information Questions
06/10/2010 ---Private Sectors
07/27/2009 ---Probabilistic Sensitivity Analysis
02/10/2015 ---Process for IRB Transitioning to Non-FDA IRB
08/28/2008 ---Process for Notifying FDA
04/11/2008 ---Processing IND Safety Reports
03/25/2002 ---Products in the treatment of depression
10/22/2012 ---Promotion and Charging for an Investigational Product
01/13/2004 ---Proper Documentation for Changes to FDA Form 1572
05/17/2011 ---Proper Process/Organization for IRB Consolidation
11/10/2005 ---Proposed rule status
08/20/2012 ---Prospective Approved Protocol Deviations
07/13/2011 ---Prospective Protocol Waivers
11/29/2010 ---Prospective Study with Survey
04/30/2007 ---Protecting Human Subjects Film
02/02/2006 ---Protecting Workers Who Participate in Research
03/23/2012 ---Protection of Research Documentation
10/22/2012 ---Protocol
09/24/2012 ---Protocol Addendum Question
10/08/2003 ---Protocol amendment
01/29/2015 ---Protocol Amendment
11/20/2014 ---Protocol Amendment Extending Duration of Multicenter Study - Questions about Sites Choosing Not To Continue Beyond Original Protocol Period
07/14/2011 ---Protocol Amendment or Administrative Letter Follow-up
06/19/2007 ---Protocol Amendment Question
09/28/2005 ---Protocol Amendments
03/07/2006 ---Protocol Amendments
07/01/2008 ---Protocol Amendments vs. Correction or Administrative Change Letters
01/03/2011 ---Protocol Changes
10/24/2008 ---Protocol Deviation- Unanticipated Problem
10/24/2008 ---Protocol Deviation- Unanticipated Problems
07/07/2006 ---Protocol Deviation- Violation
10/06/2008 ---Protocol Deviation-Violation
04/01/2003 ---Protocol deviation/violation
07/05/2012 ---Protocol Deviation Documentation
06/27/2008 ---Protocol Deviation or Protocol Amendment as Alternative to Compassionate Use Exemption
04/04/2006 ---Protocol Deviations
06/06/2008 ---Protocol Deviations
04/17/2009 ---Protocol Deviations
07/14/2009 ---Protocol Deviations
03/02/2012 ---Protocol Deviations
09/12/2014 ---Protocol Deviations
10/19/2016 ---Protocol Deviations
04/24/2008 ---Protocol Deviations and Clinical Study Reports
05/29/2008 ---Protocol Deviations and Clinical Study Reports-2
06/13/2008 ---Protocol Deviations and Clinical Study Reports-3
01/13/2009 ---Protocol Deviations Discussion
11/01/2004 ---Protocol deviations vs. protocol violations
08/29/2007 ---Protocol Deviations vs. Violations
10/07/2009 ---Protocol Deviation Versus GCP Violation
08/09/2005 ---Protocol Disapproved
05/23/2016 ---Protocol does not Provide For LAR; Subject has Lost Cognitive Capacity with Final Study Visit Pending
10/20/2009 ---Protocol Eligibility Criteria
12/03/2009 ---Protocol Exception Granted to [Redacted]
03/03/2003 ---Protocol for clinical trial
05/28/2008 ---Protocol Methodology
11/03/2015 ---Protocol Non-Investigational Meds
04/05/2005 ---Protocol procedure question
05/22/2002 ---Protocol Question
06/10/2014 ---Protocol required but also Standard of Care Procedures in the Consent
01/19/2007 ---Protocols
02/08/2013 ---Protocols
06/15/2007 ---Protocol Signature Page
04/11/2013 ---Protocol Signature Page
12/12/2006 ---Protocol Signatures
01/13/2010 ---Protocol Signatures GCP
12/21/2010 ---Protocol Steering
10/27/2011 ---Protocol Submission
05/07/2003 ---Protocols versus Sponsor Protocols
04/15/2014 ---Protocol Training Documentation
02/02/2016 ---Protocol Training Question
02/28/2013 ---Protocol Training Requirements
08/02/2005 ---Protocol Violation and Deviations Definitions
01/20/2010 ---Protocol Violations
10/30/2003 ---Protocol violations/deviations
10/26/2005 ---Protocol violations versus deviations
10/06/2008 ---Protocol Violation vs Deviation
01/08/2008 ---Protocol Waiver Question
05/06/2003 ---Protocol Waivers
10/26/2006 ---Protocol Waivers
11/17/2008 ---Protocol Waivers
06/18/2014 ---Protocol Waivers
10/02/2009 ---Protocol Waivers Inquiry
11/30/2006 ---Protocol Waivers Study Criteria
05/12/2010 ---Providing AE Info in Response to a Company Request
02/05/2014 ---Psychiatry Trials - Source Documentation
09/05/2008 ---Psychotropics for Children in Foster Care
12/18/2009 ---Publication of Negative Results
01/15/2008 ---Publication Policy
07/14/2006 ---Publications
11/18/2011 ---Publications after Termination of Research Study
03/23/2005 ---Public Disclosure Timing/Language Questions
05/31/2012 ---Public Feedback on RBM Guidance
09/15/2006 ---Public Health Surveillance Research
01/09/2007 ---Publicizing FDA Guidelines
10/23/2009 ---Public Safety and Clinical Trials
04/04/2006 ---Publishing Clinical Results
01/10/2008 ---Publishing Results
12/08/2011 ---Publishing Trial Results
05/06/2010 ---Purging Documents
03/28/2016 ---QA and QC
10/26/2006 ---QA in Clinical Trials
03/20/2006 ---QA Program
08/09/2012 ---QA Review of Blinded Drug Paperwork
10/17/2002 ---QA unit
05/20/2008 ---QA Units
11/27/2002 ---QISiteVisitProgram
07/15/2010 ---Q on IRBs--Time Sensitive
11/29/2005 ---Q on the 1572
02/04/2003 ---Qs for Stan Woolen
08/22/2003 ---Qt about study visits
04/24/2009 ---Qt Interval Guidance
11/13/2007 ---Qualification Requirements for QA Responsible Person
07/14/2006 ---Qualifications
10/12/2016 ---Qualifications of Principal Investigator and Study Site
02/17/2011 ---Qualifications Required to Monitor Clinical Trial Data
08/21/2012 ---Qualification to Conduct GCP Training
08/29/2016 ---Quality Assurance Program Inquiry
07/30/2010 ---Quality Assurance Training in Clinical Trials
09/15/2003 ---Quality Management
03/09/2012 ---Quality of Life Questionnaires and Pill Diaries
08/15/2007 ---Quality of Sub-Investigators
10/30/2006 ---Quality System Approach to GCP Audits
04/08/2010 ---Quality Systems - FDA Staff Manual Guide
03/20/2009 ---Quality Systems and GCP
08/01/2014 ---Quantity of Reserve Sample Required
01/28/2003 ---Queries
03/03/2011 ---Queries about ECRF and Final Report
02/12/2008 ---Queries GCP
06/16/2009 ---Queries on Back Translation and Signatures on Lab Reports
06/10/2010 ---Query
10/26/2010 ---Query
10/26/2010 ---Query
11/13/2010 ---Query
11/22/2010 ---Query
01/13/2011 ---Query
04/07/2011 ---Query
07/29/2011 ---Query
06/11/2012 ---Query
08/26/2012 ---Query
10/29/2012 ---Query
02/23/2013 ---Query
10/04/2010 ---Query-Central Monitoring
10/25/2012 ---Query-Outside US inspections
01/15/2008 ---Query - Submission of Investigator Information to an IND
10/28/2010 ---Query?
11/22/2010 ---Query?
10/07/2013 ---Query about Form FDA 1572
04/14/2009 ---Query About Investigator's Brochure
12/20/2005 ---Query about SAEs
02/12/2013 ---Query concerning Guidance
10/08/2010 ---Query FDA-1572
03/31/2009 ---Query Foreign Clinical Data
03/07/2012 ---Querying Clinical Data after Site Close Out and IRB Closure
10/07/2011 ---Query Monitoring
11/29/2009 ---Query of Documentation of IC in Acute Studies
07/21/2009 ---Query on 21 CFR Part 56.106
02/10/2012 ---Query on addition of Statement in ICF
09/12/2008 ---Query on Conflicts of Interest
05/22/2012 ---Query on Consent
12/01/2010 ---Query on Data Management Systems
11/03/2009 ---Query on EC membership
05/11/2016 ---Query on FDA Form 1572
04/06/2010 ---Query on Legally Acceptable Representative and Impartial Witness
10/04/2011 ---Query on Obtaining Informed Consent
02/19/2010 ---Query on Photo-ID of Patient
01/30/2008 ---A Query on Principal Investigator Qualifications
09/26/2008 ---Query Re-Timing of IND Submission Acquiring an NCT Number-1
09/26/2008 ---Query Re-Timing of IND Submission Acquiring an NCT Number 2
08/03/2011 ---Query Re: Current Version of Debarment Guidance
01/03/2011 ---Query Re: Sponsor Protocol Deviation
05/16/2005 ---Query re Declaration of Helsinki
12/31/2007 ---Query Re Financial Disclosure SPOOS Tracking
01/04/2008 ---Query Re Financial Disclosure SPOOS Tracking
10/05/2015 ---Query regarding 21 CFR 312.68 and 21 CFR 812.145
01/07/2011 ---Query regarding 1572
08/04/2011 ---Query Regarding 1572 Form
05/11/2004 ---Query regarding Accountability of Study Medication
11/07/2016 ---Query Regarding a Clinical Trial
05/31/2010 ---Query regarding Bioequivalence study in [Redacted]
04/20/2011 ---Query regarding CVs and if they Expire
09/23/2010 ---Query Regarding FDA 1572 Form
09/27/2011 ---Query regarding FDA Form 1572
11/18/2002 ---Query regarding FDA Inspection data
01/19/2012 ---Query regarding Financial Disclosure
04/10/2008 ---Query Regarding Form 3455 3454
06/02/2011 ---Query Regarding GCP
10/15/2010 ---Query Regarding ICF Process
10/29/2010 ---Query Regarding ICF Process
12/24/2011 ---Query Regarding IMP Accountability in Clinical Trials
04/13/2004 ---Query regarding Informed Consent Form
07/23/2009 ---Query Regarding IRB Registration
11/22/2012 ---Query Regarding Key Opinion Leader
05/24/2010 ---Query regarding LAR being considered as IW
10/07/2011 ---Query regarding Local Lab
09/06/2014 ---Query Regarding Obtaining Medical History for Clinical Trials
08/08/2014 ---Query Regarding Patient Sample Collection
09/03/2013 ---Query regarding Plasma Storage in Refrigerator
06/18/2009 ---Query Regarding Providing Copy of ICF to Study Subjects.
06/16/2004 ---Query Regarding Quality Control Documentation for Laboratories
09/17/2004 ---Query regarding Translations
10/01/2009 ---Query Regarding Version of Date of ICF
12/03/2009 ---Query Re IBs in an IND-Exempt Study
03/27/2008 ---Query Related to Case Report Form (CRF)
09/02/2015 ---Query related to IRB's Approval
04/06/2006 ---Query Re Monitor Observing Clinical Trial
01/27/2015 ---Query re Principal Investigator on Clinical Trials
01/25/2008 ---Query Resolution Source Documents and Copying
01/25/2008 ---Query resolution source documents and copying
10/08/2004 ---Query to CDER Drug Information
04/12/2002 ---Query to FDA
04/27/2004 ---Query to FDA
05/27/2004 ---Query to FDA
04/05/2002 ---Question
06/25/2002 ---Question
08/02/2002 ---Question
08/30/2002 ---Question
01/23/2003 ---Question
03/17/2003 ---Question
07/31/2003 ---Question
09/16/2003 ---Question
10/24/2003 ---A question
11/20/2003 ---Question
05/30/2004 ---Question
07/09/2004 ---Question
07/25/2004 ---Question
09/09/2004 ---Question
09/10/2004 ---Question
09/16/2004 ---Question
09/17/2004 ---Question
09/17/2004 ---Question
09/20/2004 ---Question
10/08/2004 ---Question
10/18/2004 ---Question
10/27/2004 ---Question
11/16/2004 ---Question
01/04/2005 ---Question
02/02/2005 ---Question
02/03/2005 ---Question
03/10/2005 ---Question
03/22/2005 ---Question
04/16/2005 ---Question
06/02/2005 ---Question
10/06/2005 ---Question
12/05/2005 ---Question
05/24/2006 ---Question
07/14/2006 ---Question
08/04/2006 ---Question
09/19/2006 ---Question
10/05/2006 ---Question
12/21/2006 ---Question
01/25/2007 ---Question
02/04/2008 ---Question
02/15/2008 ---Question
02/27/2008 ---Question
03/27/2008 ---Question
05/05/2008 ---Question
10/10/2008 ---Question
01/28/2009 ---Question
06/24/2009 ---Question
07/06/2009 ---Question
09/23/2009 ---Question
12/29/2009 ---Question
01/14/2010 ---Question
01/27/2010 ---Question
02/18/2010 ---Question
03/02/2010 ---Question
04/28/2010 ---Question
04/30/2010 ---Question
06/28/2010 ---Question
08/05/2010 ---Question
08/25/2010 ---Question
10/22/2010 ---Question
11/12/2010 ---Question
11/12/2010 ---Question
11/24/2010 ---Question
12/01/2010 ---Question
12/10/2010 ---Question
03/24/2011 ---Question
06/15/2011 ---Question
06/30/2011 ---Question
07/06/2011 ---Question
10/21/2011 ---Question
12/02/2011 ---Question
01/04/2012 ---Question
01/17/2012 ---Question
01/26/2012 ---Question
03/29/2012 ---Question
04/21/2012 ---Question
04/25/2012 ---Question
06/07/2012 ---Question
06/21/2012 ---Question
06/22/2012 ---Question
06/25/2012 ---Question
07/30/2012 ---Question
08/26/2012 ---Question
09/07/2012 ---Question
10/02/2012 ---Question
10/05/2012 ---Question
10/16/2012 ---Question
12/24/2012 ---Question
03/18/2013 ---Question
10/15/2013 ---Question
03/20/2014 ---Question
05/05/2014 ---Question
06/02/2014 ---Question
03/21/2015 ---Question
10/23/2015 ---Question
11/25/2015 ---Question
10/16/2007 ---Question - 1572 Box #3
08/06/2004 ---Question - adverse events
05/03/2010 ---Question - Box 11 of FDA Form 1572
12/13/2006 ---Question- Clinical Protocol Content
07/03/2013 ---Question - Communication with the Clinical Trial Patient
03/25/2008 ---Question-Data Management
11/02/2016 ---Question - Date Stamp on 1572
07/09/2014 ---Question - Documentation of Protocol Specific Training
08/30/2011 ---Question - FDA Form 1572 - Staff Residents on Rotations
04/07/2015 ---Question -GCP
12/11/2010 ---Question-GCP
01/06/2010 ---Question - Initiation Visit Monitoring Report
08/19/2003 ---Question- National bank of volunteers
04/09/2007 ---Question - Pregnancy Follow-up
11/21/2011 ---Question - Regulations and Investigator Initiated Research
03/16/2009 ---Question- Repeat Consent Because Of Time Lag
02/02/2016 ---Question - Specific Study
08/23/2011 ---Question - Specific Trial
06/11/2003 ---Question - Study drugs
05/05/2014 ---Question - Sub-I Support Of PI Responsibilities for a Limited Time
04/01/2009 ---Question- Timing of IRB Review of Phase II Protocol
02/29/2012 ---Question-two consent forms
10/13/2003 ---Question - Unacceptable , Disqualified IRBs
08/20/2013 ---Question - Vendor Oversight
04/13/2016 ---QUESTION. Local Imaging Locations in Section 4 of 1572?
09/20/2011 ---Question/Clarification Regarding 1572 Signature
08/05/2004 ---Question/ Protocol Waivers
04/05/2002 ---Question 3
12/18/2008 ---Question 1572
08/13/2014 ---Question: Can a Study Subject Act as an Impartial Witness?
10/29/2014 ---Question: Clinical Trials Database
03/22/2011 ---Question: FDA 1572 form from foreign Investigators
03/24/2011 ---Question: FDA 1572 Form from Foreign Investigators
03/25/2014 ---Question: FDA support of 2013 Declaration of Helsinki
05/11/2010 ---Question: Form 1572
02/01/2010 ---Question: Form FDA 1572
05/02/2011 ---Question: Guidance for Sponsors, Clinical Investigators and IRBs - 1572
12/09/2010 ---Question: Regarding change in trial site facility/reporting obligation
09/30/2014 ---Question: Siblings in Study for Rare Disease in Pediatric Population
10/19/2016 ---Question: SOPs Required for Clinical Research
10/06/2005 ---Question: Study drug may be mailed?
08/18/2005 ---Question: Subpart D regulations/Pharmacists on IRBs
07/18/2012 ---Question: Whether or Not a Sponsor Can Be In the Direct Contact with the Subject
11/02/2004 ---Question?
11/01/2006 ---Questionable Practices in Developing Countries
02/14/2007 ---Question About 5-Day Reports for Emergency Use
09/09/2011 ---Question about 21 CFR 50.25(C)
06/15/2011 ---Question about 21 CFR Part 11 and IRBs
02/04/2003 ---Question about 1572
12/24/2009 ---Question About 1572
05/07/2013 ---Question about 1572 and Clinical Research Center
10/25/2011 ---Question about 1572 Document
09/10/2013 ---Question about Abbreviations
02/16/2012 ---Question about Academic Medical Center Labs
03/28/2012 ---Question about Addendum to Statement of Investigator - Form FDA 1572
08/22/2008 ---Question About Adding Sites to Box 4 of 1572
11/25/2008 ---Question About ADE Collection in Medical Device Trial
03/24/2014 ---Question about Adverse Event
03/25/2014 ---Question about Adverse Event
05/19/2015 ---Question about Adverse Event Reporting
04/13/2015 ---Question about Adverse Events
09/02/2005 ---Question about Ages of Research-Volunteers
01/29/2015 ---Question about a Medical Food in Research Proposal
10/01/2009 ---Question About Annual Re-Approval of Research Protocols
05/19/2004 ---Question about a regulation in Clinical Trials
06/14/2004 ---Question about a regulation in Clinical Trials
07/25/2012 ---Question about Auditing a Study with Home Health Follow-Up
07/21/2015 ---Question about Biomarker Testing
10/05/2007 ---Question About Central Laboratories and Clinical Research
01/15/2015 ---Question about Certified Copy of Original Information
01/21/2016 ---Question about CFR 812.140
01/26/2012 ---Question about Changing Study Personnel
03/13/2012 ---Question about Children Participating in Research
04/10/2008 ---Question about CLIA
08/13/2015 ---Question about Clinical Data
01/23/2012 ---Question about Clinical Drug Trials
04/20/2015 ---Question about Clinical Investigations
06/25/2010 ---Question about clinical trials
07/19/2006 ---Question About Clinical Trials and Approval
06/28/2012 ---Question about Collection of Mortality Status after Withdrawal of Informed Consent
05/28/2009 ---Question about Compassionate Use
05/13/2011 ---Question about Completing FDF and FDA 1572 Forms
10/20/2010 ---Question about Completion of FDA 1572
10/21/2010 ---Question about Completion of FDA 1572
09/11/2007 ---Question About Conscious Sedation
08/05/2011 ---Question about continuing review - IRB - FDA Regulated Test Article- DRUG (UNCLASSIFIED)
09/18/2009 ---Question about CRA
02/10/2011 ---Question about CRF Collection Requirements
06/03/2009 ---Question about CROs and Devices
10/29/2009 ---Question About CSR
05/19/2016 ---A Question about CTCAE
02/09/2015 ---Question about De-Identification of Study Records
02/09/2015 ---Question about De-Identification of Study Records
09/11/2006 ---Question about Declaration of Helsinki
06/19/2012 ---Question about Declaration of Helsinki
08/21/2013 ---Question about definition of Certified Copies
02/27/2013 ---Question about Definition of Pediatric Research
12/31/2014 ---Question about Disclosing FDA-Funded Trial Results on ClinicalTrials.gov
08/30/2005 ---A Question about Drug Trial in an International Setting
08/26/2011 ---Question about Electronic Signatures vs Paper Docs
05/26/2009 ---Question About Electronic Storage
08/10/2011 ---Question about eligibility in a clinical trial based on age
01/11/2006 ---Question About Exception to Informed Consent (Emergency Settings) Research (2)
12/30/2003 ---Question about expedited amendments and continuing reviews
04/12/2012 ---Question about Expedited Category #1(b)(i)
02/23/2012 ---Question about FDA inspection
06/25/2012 ---Question about FDF and Phase IV Studies
08/15/2013 ---Question about Fecal Transplants
03/31/2011 ---Question about Financial Disclosure
03/17/2010 ---Question about Financial Disclosure by Clinical Investigators Guidance for Industry
01/21/2014 ---Question about Financial Disclosure Form Investigators
01/09/2015 ---Question about Financial Disclosure Form Investigators
09/27/2012 ---Question about Financial Disclosure Update
01/19/2012 ---Question about Form 1572
04/30/2013 ---Question about Form 1572
06/14/2013 ---Question about Form 1572
09/23/2015 ---Question about Form 1572 for Other Countries
05/29/2013 ---Question about Form 1572 Statement of Investigator
08/17/2010 ---Question about From FDA 1572
09/03/2002 ---Question about GCP
03/14/2003 ---Question about GCP
02/19/2004 ---Question about GCP Audits
03/22/2013 ---Question about GCP for Data Collection and Device Used for Both Research and Non-Research Purposes.
05/26/2006 ---Question About GCP Regulation
06/06/2005 ---Question about GCP Training
09/09/2011 ---Question about GCP Training
02/06/2006 ---Question About Good Clinical Practice
06/16/2006 ---A Question About ICF
06/19/2013 ---A Question about ICF Process Statement on Source Document
05/07/2010 ---Question about ICH E6
09/02/2013 ---A Question about Impartial Witness
09/03/2013 ---A Question about Impartial Witness
03/16/2006 ---Question About Informed Consent
03/27/2006 ---Question About Informed Consent
12/19/2013 ---Question about Informed Consent
06/21/2006 ---Question About Informed Consent Regulations for FDA Regulated Studies
02/27/2009 ---Question About Inspections in India
11/16/2010 ---Question about International Clinical Trials
05/20/2010 ---Question about interpreting adherence to GCP (vs Federal Regulation)
02/26/2008 ---Question About Investigator-Initiated Study
10/26/2004 ---Question about Investigator Brochures Submitted for Clinical Research Studies
11/16/2016 ---Question about IP Release
01/27/2012 ---Question about IRB and Software Validation
07/25/2014 ---Question about IRB Audits
12/11/2003 ---Question about IRB membership
01/11/2010 ---Question about IRB Reporting Requirements at 21 CFR 56.108(b)
08/06/2010 ---Question about IRB Review
07/19/2013 ---Question about ISO 14155_2011 (GCP for Medical Device Studies)
07/19/2010 ---Question about Listing Manufacturers of [Redacted] on Form 1572
09/22/2010 ---Question about Local Laboratory
04/25/2013 ---Question about Mailing Re-consenting Process
06/18/2003 ---Question about mandatory training
01/05/2015 ---Question about Minimal Risk NSR Device Studies at Continuing Review
07/30/2015 ---Question about Minors and Proof of Guardianship
02/27/2010 ---Question about Name Change
06/18/2013 ---Question about Need for Inter-Institutional Agreements when Study is not Federally Funded if FWA Box is Unchecked
04/10/2002 ---Question about off-label use of medications and the informed consent document.
07/12/2013 ---Question about Ownership of Closed Clinical Trial Records
05/06/2011 ---Question About Past IND Trials Data
03/17/2011 ---A Question about Pediatric Trial ICF
08/11/2010 ---Question about Phase One Study
01/22/2015 ---Question about Physician Investigator
11/11/2011 ---Question about PI
04/25/2013 ---Question about Possible Serious GCP Breaches Detected by Sponsor
02/05/2012 ---Question about Pre Screening
12/14/2015 ---Question about Protocol Deviation
08/10/2011 ---Question about Radiology Facilities on the 1572
05/03/2010 ---Question about Registering a Clinical Trial
02/19/2004 ---Question about Regulations Pertaining to Retention of Clinical Trial Specimens
10/22/2003 ---Question about reporting an adverse event
05/15/2012 ---Question about Requirements for Curriculum Vitae
12/22/2008 ---Question about Research
07/16/2010 ---Question about Retention of Medical Records by Clinical Investigator
03/15/2006 ---Question About Review Boards in General
01/25/2008 ---Question About Risks in Post-Approval Studies
11/15/2011 ---Question about Screening Tests
05/11/2011 ---Question about Section #8 of Form FDA 1572
11/12/2008 ---Question About Section 6 FDA Form
07/27/2015 ---Question about Signatures on Source Documentation
06/21/2006 ---Question About Site Name on Regulatory Documents
04/11/2013 ---Question about Source Documentation
05/16/2013 ---Question about Sponsor of an IND
03/01/2011 ---Question about Storage
03/06/2012 ---Question about Study Close Out and Pharmaceutical Drugs
11/06/2015 ---Question about Study Site Equipment
07/23/2012 ---Question about Subinvestigators
12/06/2013 ---Question about Subject Compensation
07/30/2013 ---Question about Submitting Form 3674
02/14/2006 ---Question About Television Interview
08/25/2004 ---Question about the 1998 Information Sheet update on guidance for IRBs and clinical investigators
07/29/2014 ---Question about the Definition of CI vs. PI
12/06/2010 ---Question about the Definition of Key Research Personnel in Clinical Trials
12/15/2011 ---Question about the Form 1572
07/31/2003 ---An question about the integrity of the trial conduction
04/02/2009 ---Question About the Study Title in a Consent Form
07/12/2010 ---A question about the updated ICF process
07/12/2010 ---A Question about the Updated ICF Process
02/22/2005 ---Question about the Use of SAS
04/30/2003 ---Question about Timing of Study-related Procedures
08/02/2010 ---Question about Tissue Study
10/27/2014 ---Question about Transferring Subjects from One Site to another Site
06/16/2016 ---Question about Unannounced Inspections
08/25/2008 ---Question about Unblinded Monitors
12/13/2013 ---Question about whether a published clinical study must be posted on clinicaltrials.gov for use in a 510(k)
08/16/2010 ---Question about Which Patient Group Needs to be used for SAFETY Reporting.
09/29/2016 ---Question about Who Fills Out the ICF
10/05/2009 ---Question About Written Chemotherapy Orders
10/19/2009 ---Question about [Redacted] Compassionate Use Case- IRBReview
08/26/2010 ---Question Arising from Guidance on Electronic Medical Records
11/04/2002 ---Question clarification
01/21/2014 ---Question Clinical Meaningful Difference
08/10/2005 ---Question Concerning 21CFR11
02/11/2010 ---Question Concerning 1572
10/20/2004 ---Question concerning 1572 Section 4 and 6
04/09/2012 ---Question Concerning ACLS Certification for Investigator Sites for Clinical Trials
03/16/2005 ---A Question Concerning a Radiologist and Form 1572
06/19/2013 ---Question concerning Authorization to Release Medical Records
01/23/2009 ---Question Concerning Clinical Trials
01/08/2016 ---Question Concerning ClinicalTrials.gov
02/18/2015 ---Question concerning Consent and Retention of Records
11/16/2011 ---Question Concerning Consenting Blind Research Subjects
06/07/2006 ---Question Concerning Essential Documents
12/30/2010 ---Question Concerning FDA Accredited Companies in [Redacted]
12/16/2004 ---Question Concerning Guidance for IRB and Clinical Investigators - 1998 update
12/16/2005 ---Question Concerning Guidance for IRB and Clinical Investigators - 1998 update
12/16/2005 ---Question concerning guidance for IRB and clinical investigators - 1998 update
09/08/2015 ---Question concerning Inform Consent from Parents and Assent on Minors
09/17/2004 ---Question concerning informed consent and translators Dear
09/02/2010 ---Question concerning Informed Consents
12/29/2013 ---Question concerning Language which should be used in FDA 1572
03/01/2011 ---Question Concerning Length of Clinical Trials
11/04/2010 ---Question concerning Patient Diaries and Forms
02/15/2012 ---Question Concerning the Use of Patient Initials and Birth Date on a Case Report Form
08/30/2004 ---Question Concerning the Validity of Approval Letters Received in Email Format
09/10/2004 ---Question CRO accreditation
04/15/2014 ---Question Definition of an Investigator in a Clinical Trial
09/23/2011 ---Question Drug Accountability in a Clinical Project Database
03/30/2012 ---Question EC - International trials
05/27/2008 ---Question Expanded Access
03/24/2011 ---Question FDA 1572 Form from Foreign Investigators
06/12/2006 ---Question FDA Regulation on Clinical Trials
03/25/2014 ---Question FDA Support of 2013 Declaration of Helsinki
01/11/2010 ---Question for 1572
05/26/2015 ---Question Foreign Clinical Study and Form 1572
01/25/2010 ---Question for FDA GCP/21 CFR part 11: requirement audit trail, solely electronic OR combination electronic/paper-based audit trail fulfills too?
04/29/2008 ---Question Form 1572
05/09/2008 ---Question for Transnational Clinical Research Subjects with Visits in Different Countries During the Study
07/21/2004 ---Question For You
02/18/2013 ---Question from a CRO about Communication Documentation- Email contains a url listed on [Redacted]
02/05/2013 ---Question from a CRO about Communication Documentation - [Redacted]
03/01/2006 ---Question from a Sponsor
06/29/2006 ---Question from a Sponsor-Investigator
12/11/2006 ---Question from CDER
12/15/2006 ---Question from Harvard Student
02/03/2009 ---Question from Industry
11/08/2013 ---A Question from the SOCRA Conference in Atlanta this Week
05/07/2010 ---Question from [Redacted] IRB
05/04/2011 ---Question from [Redacted] IRB regarding Data Collection after Study Closure
12/20/2010 ---Question I can't find the answer to
01/20/2006 ---Question IC Related to Research or Treatment
08/31/2011 ---A Question I Hope You Can Help in the Right Direction
09/24/2004 ---Questioning Regarding Results Handling
07/06/2010 ---Question Investigator Financial Disclosure
04/14/2009 ---Question IRB Registration Rule Effective 7/14/09
05/12/2016 ---Question Linked to Good Clinical Practice Inspections
11/21/2007 ---Questionnaire Trial A
04/11/2014 ---Question Need to Re-consent Subjects Participating in an Investigational Study
01/13/2011 ---Question New Required Element for Informed Consent
05/28/2002 ---a question of AE definition
09/08/2009 ---Question of Documenting Eligibility
05/23/2012 ---Question of FDA regulation
11/23/2010 ---Question of GCP and Research on Food
02/04/2011 ---Question of Guidance Information Sheet Guidance for IRB PI and Sponsors Clinical Investigator Administrative Actions Disqualification
08/09/2013 ---Question of Needed Cautionary Statement on Clinical Supplies
04/20/2004 ---Question on 21CFR11
11/03/2016 ---Question on 81 FR 76596
05/01/2012 ---Question on 1571 and Cross-Filing IND Safety Reports
09/28/2016 ---Question on 1572
05/04/2011 ---Question on 1572 and Medical Imaging
08/07/2008 ---Question on 1572 Block 1 and 3
05/24/2011 ---Question on 1988 Guideline for Monitoring
12/08/2008 ---Question on an Unanticipated Problem
05/27/2015 ---Question on BA/BE Studies Exempt from IND Safety Reporting to the IRB
08/20/2009 ---Question on Blood Storage in Sub-Studies
07/16/2012 ---Question on CFR 45 § 46.115
09/24/2009 ---Question on CI Discontinuation
04/01/2015 ---A Question on Clinical Trial
04/03/2003 ---Question on Clinical trial forms required by the FDA
08/28/2015 ---Question on Clinical Trials
07/06/2010 ---Question on Clinical Trials in Puerto Rico
12/09/2009 ---Question on Completing 1572
05/19/2004 ---Question on completion of laboratory section of Form FDA 1572
12/15/2015 ---Question on Complying to 21CFR 56.107 (e) Conflict of Interest
09/02/2016 ---Question on Computer Validation
09/29/2008 ---Question on Conducting Trials at Foreign Clinical Sites
05/23/2008 ---Question on Confidentiality in Clinical Trials
03/18/2010 ---Question on Confidentiality of Clinical Trials
12/21/2012 ---Question on consistency between FDA 1572 form and site delegation log
03/31/2009 ---Question on Continuing Review Dates
04/18/2005 ---Question on CSUCT Reference
04/12/2010 ---Question on Decoding Treatment for Blinded Trials Post Study Completion
11/18/2016 ---Question on Delegation of Authority Log
05/27/2004 ---QUESTION ON DEVICE GCP INSPECTIONS
03/07/2016 ---Question on Device Reporting
06/09/2010 ---Question on Disclosable Financial Agreements
09/08/2009 ---Question on Documenting Eligibility
07/13/2011 ---Question on Draft guidance on Financial Disclosure by Clinical Investigators
09/25/2013 ---Question on e-signature implementation
07/03/2002 ---Question on Eligibility Waivers
01/23/2014 ---Question on EMR access
10/09/2008 ---Question on FAQ Guidance
04/20/2010 ---Question on FDA 1572 Form - Temporary Replacement of PI
07/08/2014 ---Question on FDA Form 3674
03/13/2012 ---Question on FDA Guidance for Continuing Review Intervals
06/03/2011 ---Question on FDA Response to an Investigator's Response to a FDA Form 483
06/03/2011 ---Question on FDA Response to an Investigator's Response to an FDA Form 483
04/01/2005 ---Question on Financial Disclosure
02/24/2011 ---Question on Financial Disclosure
05/03/2004 ---Question On Follow-Up
07/22/2009 ---Question on Form 1572 Block 4 Clinical Labs
05/30/2013 ---Question on FWAs
11/02/2009 ---Question on GCP
06/05/2014 ---Question on GCP 4.8.10, 21 CFR 50.25 and FDA Access to Medical Records for Inspection/Monitoring (UNCLASSIFIED)
11/03/2010 ---Question on GCP and Foreign Clinical Trials
10/29/2013 ---Question on GCP Data Integrity
06/27/2005 ---Question on GCP policy
03/27/2014 ---Question on GCP Training for a Site
11/08/2013 ---Question on Good Clinical Practice regarding Record Retention for DMF
03/12/2014 ---Question on Good Clinical Practice regarding Record retention for DMF
10/16/2008 ---Question on Guidance Document-Acceptance of Foreign Clinical Studies
11/04/2011 ---Question on Guidance for Oversight of Fully Outsourced Clinical Trials
11/25/2014 ---Question on How to Complete Gender in CRF
04/16/2010 ---Question on Human Research Study Guidance
07/06/2009 ---Question on ICF Practice at Clinical Sites
04/05/2012 ---Question on ICF signature
07/26/2008 ---Question on Incentives
07/26/2008 ---Question on incentives
11/10/2009 ---Question on Informed Consent and Protocol Amendments to IND
03/30/2011 ---Question on Informed Consent Document - Signatures and Dates
02/16/2012 ---Question on Informed Consent Elements, 21 CFR § 50.25(c)
11/28/2014 ---Question on Insurance for Sponsors
02/19/2015 ---Question on Interpretation of GCP
01/20/2004 ---Question on Investigational Plans/IRBs
01/21/2004 ---Question on Investigational Plans/IRBs
02/25/2009 ---Question on Investigator's GCP Qualification
05/24/2004 ---Question on Investigator/Subject Ratios
12/30/2012 ---Question on Investigator Payment Incentives
05/12/2005 ---Question on Investigator Regulatory Binder
05/10/2011 ---Question on Investigator Statement of Agreement for Devices
04/18/2002 ---Question on labeling process of clinical products
04/08/2009 ---Question on LAR Impartial Witness
06/24/2013 ---Question on New (Feb 2013) FDA Guidance on Financial Disclosure for Clinical Studies
04/07/2006 ---Question on Non-English Speaking Subjects
03/13/2012 ---Question on Observational/Non-Interventional Studies
09/02/2003 ---Question on Old Regulations
03/22/2016 ---Question on OMB Control Number Expiration
08/08/2013 ---Question on Original vs Copies of Regulatory Documents
04/19/2011 ---Question on Patient-Reported Outcomes (PRO)
04/28/2010 ---Question on Patient Eligibility to Enter a Clinical Trial
12/05/2005 ---Question on Phase I Drug Trials
11/10/2010 ---Question on PHI in Research Subject Files
09/10/2014 ---Question on Pre-Existing Condition Diagnosed during AE Reporting Period
01/20/2010 ---Question on Presence during Pt Visit
02/21/2012 ---Question on Proposed Rule - Docket No. FDA-2008-N-0115, Published in FR Volume 75, No. 33, 2/19/2010
12/10/2010 ---Question on Protocol Waivers
08/11/2010 ---Question on Record Retention
10/07/2013 ---Question on Reporting for Device Trials
10/02/2012 ---Question on Reporting of Unanticipated Problems Involving Risks to Subjects or Others
01/27/2010 ---Question on Requirements for Subject Lost to Follow Up
08/25/2014 ---Question on Retention Time Period for Plasma Samples
09/29/2016 ---Question on SAE Definition-Classification
12/01/2008 ---Question on Safety Reports Submission
06/03/2014 ---Question on Screening
09/02/2009 ---Question on Source Documentation of Causality for AEs and Abnormal Lab Values
06/11/2008 ---Question on Source Documents
04/21/2011 ---Question on Sponsorship Responsibilities
04/25/2011 ---Question on Sponsorship Responsibilities
02/27/2008 ---Question on Status of Draft Guidance
12/05/2016 ---Question on Storing Consent Electronically
10/01/2013 ---Question on Study Staff Not in the Direct Employ of the Investigator
06/29/2011 ---Question on Study Subject Material -Informational Wallet Cards
03/08/2013 ---Question on Subject Lost to Follow-Up
07/03/2004 ---A Question on Subjects at Foreign Sites
02/01/2013 ---Question on Subject Screening Log Purpose
04/30/2015 ---Question on Subjects Deceased prior to End of Study
09/24/2014 ---Question On Submission of Investigator Information to FDA for IND Protocol Investigators, Domestic and Foreign
10/07/2016 ---Question on Submission of Reportable Changes to the FDA Form 1572
04/14/2014 ---Question on Text in ICF Disclosing Treatment or Dose after Trial is Over
05/20/2010 ---Question on the Rules of Inclusion/Exclusion Criteria
07/23/2014 ---Question on the Use of the Short Form Informed Consent CFR 50.27(b)(2)
04/01/2015 ---Question on Transfer of Study Records
05/17/2006 ---Question on Unanticipated Use of Blood Sample Aliquots After Study Completion
10/25/2013 ---Question on Withdrawal of Consent vs. Withdrawal of Trial
06/18/2012 ---Question Patient Referral Payments
09/21/2015 ---Question Pertaining to Enrolling a Subject into a Clinical Trial
10/25/2012 ---Question pertaining to Forms FDA 1572
08/13/2015 ---Question Pertaining to Re-Consenting and Notifications
12/15/2016 ---Question Pertaining to SQV Report vs. SIV Report
10/14/2005 ---Question Please
08/26/2011 ---Question Please
08/04/2016 ---Question Please
04/24/2014 ---Question Re. Warning Letters
12/29/2009 ---Question Re 21CFR56.108(b)- Reporting Requirements
11/14/2005 ---