Journal of Clinical Research Best Practices
Table of Contents

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The Site Monitor Reborn as Consultant, Trainer and Manager
It's about to get interesting

Urgent Ethical Challenges in Human Subjects Protection
Five big problems that are overdue for attention

How Many Are Enough? Statistical Power Analysis and Sample Size Estimation in Clinical Research
What is "power" and why does it matter?

Industry Performance on Postmarketing Commitments
Not much progress this year

How Accurate are the FDA Investigator Databases?
Are there skeletons in your closet that don't belong to you?

Review: “Expediting Drug and Biologics Development: A Strategic Approach”
Let's get moving

Review: “Phase IV Clinical Trials: Post-Marketing Study Management Structure, Strategy and Benchmarks”
How to manage growth of 23% per year

Review: “Clinical Trial Compliance in Underdeveloped Countries”
"Underdeveloped" is not a synonym for "stupid"

Review: "Handbook of Clinical Trials"
Ready to put your toe in the water?

Review: “A Guide to US Reimbursement for Drugs, Medical Devices, and Diagnostics”
It's just money

Update on MAGI, the Model Agreement Group Initiative

Spotlight on Research Fees: Trends in Cost-per-Subject Pricing
Let's look at the numbers

Good Clinical Practice Q&A: Focus on IRBs
You too can be a GCP expert

First Clinical Research Stock Index (FCRI)
Not a good month

What am I Missing Here? Thought-Provoking Questions for the Clinical Research Industry
Site questionnaires; Investigator meetings

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