- Key Takeaways
- Institutional Review Board (IRB) Reporting Flowchart
- Adverse Event (AE) Reporting Flowchart
- Case Study: Interim Monitoring Visits
This case study gives a glimpse of our modules launched by USC School of Pharmacy.
- Poll time! The topic I would like for the spring 2019 boot camp is:
- A severe AE is the same thing as a serious AE.
- If an AE becomes expected during the course of a multi-site investigator-initiated trial, the central IRB is responsible for updating all participating sites.
- For a serious adverse event that is not fatal or life-threatening but which is drug related and unexpected, as the sponsor I must submit this to the FDA in how many days?
- In a clinical trial, my clinic has to submit serious adverse events to the sponsor if I assess them as related to study drug.
- My clinic just learned that one of our study subjects passed away in hospice. I can report “death in hospice” as the adverse event term until I learn the cause of death. Until I learn the cause of death, I do not have to provide an assessment of relatedness to study drug.
- Only safety data from controlled clinical trials is required to be collected and submitted to regulatory authorities
- Experience sharing about the boot camp
- Q&A session
Eunjoo Pacifici, PharmD, PhD
Director, Regulatory Knowledge and Support