- Definitions – Sponsor, Investigator, Sponsor-Investigator
- Investigator-Initiated Trial (IIT) vs Federally Funded vs Industry
- Various types of Investigator-Initiated Trials (IITs)
- Intricacies of conducting IIT
- Why do we collect Adverse Event (AE) data?
- AE record keeping
- Unexpected vs Expected Updates on IIT
- Source Documentation of AE
- Source documentation of AE and Serious Adverse Event (SAE)
- AE vs SAE Reporting
- Source documentation vs Data capture
- Other considerations
- Is severe the same as serious?
- Standardized Grading (Severity)
- Reporting: When and to whom?
- Reporting: When and where?
- Who should be reviewing AEs and SAEs on IIT?
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.
Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy | firstname.lastname@example.org