The course 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.
This is a core class in the Clinical Research Operations Program.
Winter: Thursday, Mar. 23 at 9:00 am
Spring: In-person class on April 28, 2023, GCP Bootcamp, Day 1
Summer: Thursday, Jun 14 at 12:15 pm
Fall: Wednesday, Nov. 8 at 12:15 pm