Pharmacovigilance and Safety Reporting Boot Camp Session 3: Safety Reporting in Investigator-Initiated Trials (2018)

In this series, we will discuss pharmacovigilance and safety reporting in clinical trials. Case studies are presented throughout the series.


Course Syllabus/Topics

  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?

Acknowledgement

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


NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.