GCP Questions, FDA Answers, 2019 Edition — PDF
130+ GCP questions you never thought to ask — and their answers
CenterWatch’s staff has culled through hundreds of questions posed to the Office of Good Clinical Practices (OGCP) and curated more than 130 of the most relevant of responses for you — segmented by category — saving you the time and frustration of sifting through the information yourself.
Some of these may be questions you’ve asked yourself and others you may not have 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 adverse events
- Investigator responsibilities
- Financial disclosure
- Inspections of clinical investigators and sites
- Data privacy
- Electronic medical records
- Part 11
- Delegation of authority
- Geriatric populations
- Randomization and unblinding
- Principal investigator termination
This book also includes links to documents and other resources most often recommended by OGCP:
- ICH E6 (R2): Good Clinical Practice
- FDA Inspections of Clinical Investigators Information Sheet
- Informed Consent Information Sheet
- Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
- Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects.
Get answers to GCP questions clinical research professionals ask of OGCP. Order your copy today.
Who Will Benefit
- Manufacturers’ R&D departments
- Hospitals’/medical centers’ clinical trial heads
- Laboratory managers
- Legal counsel