Training Education and Compliance Help (TEACH) is a collaborative, educational initiative designed to assist the Principal Investigators (PI) and their research team with regulatory compliance. As part of TEACH, Compliance staff meet with researcher(s) conducting U.S. Food and Drug Administration (FDA) regulated research and/or a Medicare Qualifying Clinical Trial after an IRB application is initially approved but before research begins. Compliance staff will provide researcher(s) with regulatory information specific to the type of research study (e.g. FDA regulated, clinical research billing compliance, HIPAA). If the PI has multiple FDA regulated projects, the need for additional visits will be dependent upon on whether there are additional regulatory components not previously discussed (e.g. device study instead of a drug study). TEACH may also be performed for other research studies or by request.
If you would like to schedule a TEACH session, please contact the Compliance office by phone: 517-432-4502 or by email: hrl@msu.edu. The TEACH session will be customized for your research.