Pharmacovigilance and Safety Reporting Boot Camp Session 5: Safety Reporting in Industry-Sponsored Trials and Case Studies - Part 1 (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. Collection of Adverse Events (AEs)
  2. Adverse Event vs Reaction
  3. Who determines AE vs Reaction?
  4. Serious Adverse Event (SAE) Reporting Decision Tree
  5. Who makes SAE assessments?
  6. Seriousness
  7. Severity
  8. Related vs Unrelated - Sponsor
  9. Expected vs Unexpected - Sponsor
  10. Analysis of Similar Events - Sponsor
  11. Sponsor Medical Comment
  12. Reporting: 7-day alert
  13. Reporting: 15-day alert
  14. Reporting: Unblinding/Unmasking
  15. 21 CFR 803.3 - Definitions
  16. 803.12
  17. 803.53 - Manufacturer: 5-day report
  18. 21 CFR 803.50(a) MDR: 30-day report
  19. 21 CFR 820.198(a)(3) Complaints: Evaluate for Medical Device Reporting
  20. 21 CFR 803.3 - Who reports?
  21. Exercise-1: Clinical Trial Adverse Event
    The case study gives a practical view of SAE reporting – right from how it is to be done, duration and also the kind of terms to be used in the form.

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.