Full course description
The seminar will discuss what information is reportable (ie. adverse events, regulatory non-compliance, protocol deviations, annual reports, new information) as well as to whom the information is reportable, and the specifics surrounding required IRB reporting by providing guidance on when and how to submit unanticipated problems, noncompliance, and other IRB reportable events.
By attending this workshop, you will:
- Identify what should be reported to whom and via which mechanisms
- Recognize the difference between routine reports and emergent or prompt reports
- Know what documents are required for submission of a prompt report to the IRB
- Understand the role of the IRB and external reporting requirements
Course open to all faculty, fellows/residents, staff working on clinical research projects at Stanford.
Date: Wednesday, Oct. 27, 2021
Time: 12:15 - 1:45 pm
Location: Virtual / Live Webcast
Note: The zoom link will be sent to enrolled participants two days before and the day of the class. After enrolling, return to the course website to download the course materials and find the zoom information.
Certificate Program – Core Class
Core Competency: Clinical Trials Operations