Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 3: Safety Reporting in Investigator-Initiated Trials (2018)

1. Definitions – Sponsor, Investigator, Sponsor-Investigator
2. Investigator-Initiated Trial (IIT) vs Federally Funded vs Industry
3. Various types of Investigator-Initiated Trials (IITs)
4. Intricacies of conducting IIT
5. Why do we collect Adverse Event (AE) data?
6. AE record keeping
7. Unexpected vs Expected Updates on IIT
8. Source Documentation of AE
9. Source documentation of AE and Serious Adverse Event (SAE)
10. AE vs SAE Reporting
11. Source documentation vs Data capture
12. Other considerations
13. Is severe the same as serious?
14. Standardized Grading (Severity)
15. Reporting: When and to whom?
16. Reporting: When and where?
17. Who should be reviewing AEs and SAEs on IIT?

Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy | ashtekar@usc.edu