Regulatory Science Symposium: "Ensuring Clinical Trial Compliance" Session 2 - Good Clinical Practice (GCP) and FDA Inspection Preparation

Competencies: Good Clinical Practice, Audits, Pharmacy, Regulatory Science, Clinical Research and Regulations, Project Management, Clinical Trials, Regulatory and Quality Sciences, Clinical Trial Quality

Course Syllabus/Topics:

1. Session Outline: Definition of Goals of GCP, Brief History of GCP, ICH E6- GCP, FDA Regulations as they relate to GCP, Essential Documents and Records, Preparing for GCP
2. Good Clinical Practice: GCP defined as standard for the design, recording
3. Goals of GCP: shared responsibility, creating quality data and ethically
4. History of GCP:
5. ICH E6-GCP: 2nd revision 2015, R3 is in progress,
6. ICH-CGP
1. FDA endorsed guidelines
7. FDA Implementation of GCP
1. Topics and requirements are covered in multiples
2. Addressed specifically using the term ICH only in Section
8. Importance of GCP as a Global Standard
9. ICH-GCP principles: *ethically, protect people in the studies
10. ICH E6-GCP Revision 2 (2015): address the idea of electronic record-keeping
11. ICH E6-CGP Added QMS: QC + QA = QMS
1. Key Quality Indicators (KQIs)
12. What are “GCP essential Documents”?
1. Section 8: what are the essential documents, evaluate how it was conducted, quality of data
2. Where these documents live
3. Important when writing up reports as a sponsor
13. ICH Essential documents
1. Highlights the need to update GCPs
2. Before/During/After the trial - at site and/or sponsor
3. GDP: how to document non-approved material, procedures for blinded trials
14. US Financial Disclosure in Clinical Trials
15. ICH Essentiality of Records: Documents vs Records
16. Source Documents/Records
1. Per ICH E6(R3)
2. What were the original records and how they changed
3. Accurate & Complete records
17. What is considered a Source Document/Record
1. Per ICH E6(R2)
18. ICH Essential Documents
1. Signed consent forms
2. Screening/Enrollment Logs
3. Case Report Forms:
4. Adverse Event/Serious Adverse Event Forms
5. Drug Accountability
19. Case Report Forms
1. What reviewers are looking at: Consistency & discrepancies
20. Source Documents/Records
21. ICH GCP Audit and FDA CI Inspections: Evaluate the conduct of the trial, compliance with SOPs, GCP
22. FDA Site Inspection of Clinical Investigators (CI)
1. Re-create trial
2. How did it adhere to regulations, protocol
3. CIs
23. Clinical Investigator (CI)/Site Inspections
1. Items to have on hand
24. Pre-Inspection Preparation
1. Meeting space: space for auditors
2. Document availability
3. Facility preparation
4. *Employee Readiness: FDA will speak with subject matter experts
25. Selecting and Training SMEs
1. Clear and concise
2. Perform under stress
3. No pointing fingers
4. Adapt to unexpected Qs
26. Training SMEs
1. SOPs, Protocols, Company/local policies, federal regulations
2. Questioning techniques:
1. Answer yes or no, stick to facts
2. Avoid answering leading questions reactively
3. Use of Third-party prep
27. Keys to Success
28. FDA Inspections
29. Responses to FDA Inspection Findings
1. Respond within 15 days
30. Post-inspection Activities
31. Possible Outcomes of FDA GCP Inspections
32. Questions

Acknowledgements:

Accompanying text created by: Roxy Terteryan, Project Administrator, SC CTSI
Rushaanaaz Sokeechand, Student Worker; Mahita Parasa, Student Worker