GCP Questions, FDA Answers

FDAnews’ staff has culled through hundreds of questions posed to OGCP and curated more than 175 of the most relevant of responses for you — segmented by category — saving you the time and frustration of sifting through the questions and responses.

Some of these may be questions you’ve asked yourself and others you may not have even thought of. But all of them get straight to the heart of your role as a clinical trial professional — how to conduct safe, effective, compliant trials that can win FDA approval.

This collection sheds light on some of the most difficult and important topics in clinical trial research, including:

• Dealing with protocol deviations
• Investigator responsibilities
• Communicating with trial subjects
• Inspections of clinical investigators and sites
• Monitoring investigators
• Submitting information to ClinicalTrials.gov
• Good documentation practices
• Laboratory certification
• Randomization procedures and unblinding
• IND waivers
• Recruitment advertising
  

This book also includes copies of documents and other resources most often recommended by OGCP:

• ICH E6: Good Clinical Practice Consolidated Guidance
• Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: FDA Inspections of Clinical Investigators
• Informed Consent Information Sheet
• Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
• Elaboration of Definitions of Responsible Party and Applicable Clinical Trial
• Determining Whether Human Research Studies Can Be Conducted Without an IND
• Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects

Who Will Benefit

• Regulatory affairs
• Quality manager
• Senior management
• R&D