The First Clinical Research Bookshelf

160 clinical research books -- Essential reading for clinical research professionals

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Assessing Competence to Consent to Treatment: A Guide for
Physicians and Other Health Professionals

Thomas Grisso & Paul S. Appelbaum, 1998.  REVIEW

Biologics Development: A Regulatory Overview, Third Edition
Mark Mathieu, editor, 2004.  REVIEW

Children in Medical Research: Access versus Protection
Lainie Friedman Ross, 2006.  REVIEW

Clinical Research and the Law
Patricia M. Tereskerz, 2012.  REVIEW

Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance
Fay A. Rozovsky and Rodney K. Adams, 2003.  REVIEW

Ethics and Regulation of Clinical Research, 2nd Edition
Robert J. Levine, 1986.  REVIEW

The Ethics and Regulation of Research with Human Subjects
Carl H. Coleman, Jerry A. Menikoff, Jesse A. Goldner, and Efthimios Parasidis, 2015.  REVIEW

Ethics and Research with Children: A Case-Based Approach
Eric Kodish, editor, 2005.  REVIEW

Evaluation of Capacity to Consent to Treatment and Research
Scott Y.H. Kim, 2009.  REVIEW

The Form 1572: A Reference Guide for Clinical Researchers,
Sponsors, and Monitors

Marc P. Mathieu, editor, 2008.  REVIEW

The Global GCP Compliance Report 2006: US, EU, and Japan
Barnett Educational Services, 2005.  REVIEW

Global Regulatory Systems: A Strategic Primer for
Biopharmaceutical Product Development and Registration

Henrietta Ukwu, 2011.  REVIEW

Good Clinical Practice: A Question & Answer Reference Guide
Mark P. Mathieu, 2009.

Healthcare Compliance Professional’s Guide to Clinical Trials
F. Lisa Murtha and Leah Guidry, editors, 2008.  REVIEW

IND Submissions: A Primer
Meredith Brown-Tuttle, 2009.  REVIEW

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective
Pierre-Louis Lezotre, 2013.  REVIEW

Medical Device Development: Regulation and Law, 3rd Edition
Jonathan S. Kahan, 2014.  REVIEW

The Pharmaceutical Regulatory Process, Second Edition
Ira R. Berry and Robert P. Martin, editors, 2008.  REVIEW

Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation”
Thomas P. Stossel, 2015.  REVIEW

Principles of Good Clinical Practice
Michael J. McGraw, Adam N. George, Shawn P. Shearn, and Rigel L. Hall, editors, 2010.  REVIEW

The Stark Law: A User’s Guide to Achieving Compliance
Gina M. Cavalier, Christopher G. Janney, Albert W. Shay, Gadi Weinreich and Howard J. Young, 2005.  REVIEW

State-by-State Clinical Trial Requirements Reference Guide
John C. Serio and Dorothy L. Puzio, 2006.  REVIEW

Writing and Managing SOPs for GCP
Susanne Prokscha, 2015.  REVIEW

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