GCP Enforcement Trends

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GCP Enforcement Trends

From January 2010 through June 2015, the FDA issued 89 warning letters to clinical investigators, sponsors and IRBs for good clinical practices (GCP) violations.

If you read all 89 one by one, you would find them to be compelling reading.

But, the real power of the warning letters comes from looking at them closely as a 5+ year continuum.

With the report in hand, you'll quickly become aware of the FDA's priorities and learn to recognize inspection red flags that almost always lead to GCP violations.

You'll see patterns to watch for in the FDA's GCP enforcement activities, and learn some surprising lessons that will help you stay in full compliance with the agency's requirements.

You'll go behind the scenes to learn about real-life inspection pitfalls and how to avoid them. The report recounts successful (and unsuccessful) attempts to prevent 483s from turning into warning letters and shares insights about others' past mistakes in real-life scenarios that include:

  • The site that tried to solve its problems managing continuing review, only to have the FDA to say the "improvements" actually made them worse.
  • A sponsor's carefully crafted informed consent documents that overlooked one of the most basic requirements.
  • The investigator who upended a trial by deviating from a basic element of the protocol without anyone noticing.
  • And more …

This management report shows you the real-life lessons you can learn from inspection results — findings that will help keep you in tune with GCP enforcement practices and avoid warning letters.

GCP Enforcement Trends might very well offer the best business knowledge you'll come across this year. Don't hesitate. Order your copy today.


PDF Edition

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Table of Contents

  • Introduction
  • IRB Enforcement Actions
  • Clinical Investigator Enforcement Actions
  • Sponsor Enforcement Actions
  • And More …

View the entire TOC

Who Will Benefit

  • Clinical trial managers
  • Clinical investigators
  • IRB members
  • Internal auditors
  • Regulatory affairs directors
  • Compliance officers
  • Legal counsel

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