GCP Questions, FDA Answers, 2021 Edition

CenterWatch’s staff has culled through hundreds of questions posed to OGCP and curated more than 100 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.

GCP Questions, FDA Answers provides answers to questions about guidelines from the FDA, including those related to adverse events, investigator responsibilities, electronic medical records and data privacy protection. You’ll find advice on some of the most difficult and important topics you will face, along with documents and resources that will bring clarity to your trial practices.

Report Takeaways:

• General Clinical Trial Topics
1. Dealing with adverse events
2. Working with special populations


• Investigation Topics
1. Understanding investigator responsibilities
2. Inspecting clinical investigators and sites
3. Managing investigational products


• Electronic Records and Data Topics
1. Managing good documentation and data integrity
2. Using electronic medical records
3. Handling data privacy and human research subject protection


• Documents and Resources
1. ICH E6 (R2): Good Clinical Practice
2. ICH E3: Clinical Study Reports
3. FDA Inspections of Clinical Investigators Information Sheet
4. Informed Consent Information Sheet
5. Oversight of clinical investigations: A risk-based approach to monitoring
6. Investigator responsibilities: Protecting the rights, safety and welfare of study subjects
7. Considerations when transferring clinical investigation oversight to another IRB
8. FDA’s Guidance for Industry — Part 11, Electronic Records, Electronic Signatures: Scope and Application

Guidelines and regulations from the FDA are always evolving. But you can better understand the many changes that have occurred and affect your trials. Learn from the many responses other professionals have received and ensure you are prepared to keep your trials on track.

Get your answers — and ensure your trials’ success — now.

Who Will Benefit

• Drugmakers
• Devicemakers
• Clinical Research Organizations
• Clinical trial sponsors
• Clinical trial investigators
• Independent Review Boards
• Consultants
• Researchers and investigators
• Research and development teams
• Clinical trial heads
• Laboratory managers
• Legal counsel
• Trial design professionals
• Data integrity professionals
• GCP professionals