Regulatory Science Symposium: "Ensuring Clinical Trial Compliance" Session 6 - Bioresearch Monitoring Program (BIMO), Good Clinical Practice Inspections, Compliance and Warning Letters

Competencies: Audits, BIMO, 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. FDA BIMO Program
1. Audits performed by FDA investigators
2. Random, cause
3. On-site inspections, data audits and remote regulatory assessments
4. Monitor all aspects of conduct and reporting of FDA regulated research
2. Commonly used terms
3. FDA BIMO metrics
1. BIMO inspections final classifications by Center
4. FDA site inspection of clinical investigators- objectives
1. Safety reporting
2. Protocol adherence
3. Source of CFR data submitted to FDA
4. others
5. Focus on SOURCE documents/ records
1. Does it meet the standard for ALCOA?
2. Accurate, legible, contemporaneous, original, attributable
3. May be defined in protocol
6. Clinical investigators
7. Institutional Review Board (IRB)
1. Common IRB inspectional observations
2. Involvement of RDRC- Radioactive Drug Research Committee
8. Sponsors and CROs
9. Responses to FDA Inspections
1. FDA requests a response within 15 business days
2. Response is strongly advised
3. Include corrective actions and preventive action to prevent the finding from occurring again
10. FDA Actions Post-Inspection
11. Inspections outcomes
1. Acceptance or rejection of study data
2. Product approval or complete response to sponsor
3. Warning letter or enforcement action
4. Education of study site
5. Disqualification proceedings for clinical investigator
6. Results posted on Clinical Investigator Inspection List (CLIL)
12. FDA Warning letters
1. Issued for compliance issues
2. Most 483’s do not result in warning letters
13. A strategy for sponsor BIMO readiness
1. Consistent documentation management
2. Robust study file management
3. Develop and review SOPs
4. Importance of documentation
5. Monitor study operations and compliance
6. Seek expert support
7. Conduct BIMO inspection training and mock inspections
14. Do mock inspections (best thing you can do!)
15. Example warning letter and discussion
16. Raffle prize winner announcement

Acknowledgements:

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