Regulatory Science Symposium: "Ensuring Clinical Trial Compliance" Session 3 - Sponsor Audits: Data Handling and Reports

Competencies: Audits, 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. Session Outline: Auditing personnel, QA vs QC, Data Audits, Report Audits
2. Quality Data and Reports: How necessary it is to have a system in place
3. Auditing Personnel: be external to the study, objectivity is key. Having a dual role is only acceptable if they are not directly involved
4. QC vs QA Example: Horse in the stable vs ensuring stable doors work
5. ICH GCP - Different Types and Timings of Audits: diff ways to look at data, make sure it is correct before generating output,
6. Data Audits: Not necessarily 100%, only key quality parameters
1. Regulatory briefing books: make sure they are thorough
2. Will focus on data management activities
3. Audit Plan: address the extent and nature of sampling for audit
7. Clinical Study Report (CSR) Audits
1. Description of study, statistical methods used
2. Items needed: Protocol and amendment(s)
3. Investigator’s brochure
4. Black CRF
5. Templates available for reports
6. Ensure randomization is done correctly,
7. Other optional activities (QC and QA):
8. Appendices
9. Tables, Listings and Figures
8. Keys to Success
9. Questions

Acknowledgements:

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