Regulatory Science Symposium: Pharmacovigilance and Safety Reporting 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.

Ethics & Participant Safety
Regulatory & Quality Sciences
Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 3: Safety Reporting in Investigator-Initiated Trials (2018)

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

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