Regulatory Science Symposium: "Ensuring Clinical Trial Compliance" Session 4 - Good Clinical Practice for Site Audits

Competencies: GCP, IRB, Pharmacy, Regulatory Science, Clinical Trial Quality, Clinical Research and Regulations, Project Management, Clinical Trials, Regulatory and Quality Sciences, Clinical Trial Workforce

Course Syllabus/Topics:

1. Some Key GCP
2. Source Documents
3. “They forgot the R” - GCRP
4. Protocol Diagram: Solar System
1. Protocol is the sun
2. Data, Design, AERs are the planets
3. Prevent catastrophic events by keeping things in orbit
5. Additional Principles
6. Implementation of Quality Systems with a Risk Based Approach
7. Quality Driven By; Plan - Do - Check - Act
8. PDCA Deming’s Circle scientific method, quality circle
9. Quality in a Clinical Trial
1. Plan quality into the trial
2. QTLs: Critical to Quality
3. Find what level of variation will be acceptable
4. Verifiable standards for processes that control for variation
10. GCP Quality System
11. Do Check and Act: *Effectiveness checks
12. Anatomy of an Audit: File Audit certificate,
13. Common Terminology: Audit Plan, Audit Program, Audit Report, Audit Certificate, Audit Evidence, Audit Criteria, Audit funding
14. Some of the Types of GCP Audits Activities
1. TMF audits, directed of For Cause Audits, REMs program
15. Writing a Great Audit Observation: Be a good communicator to be a good auditor
1. Reference the criteria that the observation supports
2. No opinions or advertizing
16. Great Observation: Classified according to Critical, Major, Minor. Further categorize by type of compliance
17. General CAPA Process: identify issue & impact, ensure issue does not reoccur, report issue & resolution to management
18. Root Cause Analysis
1. Identify
19. Who is responsible for ensuring compliance
20. The role of technology in GCP audits: use of e-records and source data
21. Study Build and Validation:
1. Validation Plan , Specifications, Test Documents, SOPs -> Validated eClinical System -> Study Database -> Database specification -> User Requirements
22. General Responsibilities of Clinical Investigator
1. 21CFR 312.60
23. Statement of Investigator Form FDA 1572:
1. Conduct the study in accordance with
24. Auditing Outsourced or Vendors
1. Transfer of obligation needs to be formalized
2. Obligation not captured are not transferred
3. Example: management of 3rd party vendor (make sure it is not further outsourced, be involved in the decision-making), change control, QC responsibilities, good escalation process
25. Quality Assurance in Clinical Trials Investigator Compliance Program
26. Investigator Compliance Program Authority Administration
1. Essential documents
2. Program IRB/IEC
3. Informed Consent: Process, Language, Comprehension, Documentation
4. Source Documents: Subject records/source documents
27. ALCOA - EA Data Integrity
28. Protocol Compliance
29. Investigational product accountability
30. CRF Completion
31. FDA Warning Letters
32. Conclusion

Acknowledgements:

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