This 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. The seminar will also discuss specifics surrounding required IRB reporting by providing guidance on when and how to submit unanticipated problems, noncompliance, and other IRB reportable events.
Open to all faculty, fellows/residents, staff working on clinical research projects at Stanford.
Shana Stolarczyk, CIP, IRB Panel 1 Manager, Research Compliance Office
Anthea Buchin, MS, Clinical Trials Regulatory Specialist, Clinical Research Quality (CRQ), Research Office
Certificate Program CORE
Competency: CT Operations
*This class can be taken independently of the Certificate Program in person or via webcast.