DSMP Guidelines

DSMBs

Adverse Events

The Research Subject Advocate (RSA)

   As of May, 2001 the NCRR stipulated that every GCRC protocol have a Data Safety and Monitoring Plan (DSMP) and that each GCRC shall have a Research Subject Advocate (RSA).  At UTMB, Michele A. Carter, PhD occupies this newly created position.  Specifically, the RSA is responsible for the following:

Michele A. Carter, PhD

• To ensure adequacy of the data and safety monitoring plans (DSMPs), which may include data safety monitoring board (DSMB) if required by an NIH Institute or GCRC Advisory Committee (GAC)
• To facilitate Principal Investigators' reporting of adverse events
• To serve as a source of information for research subjects, investigators, nurses, study coordinators and other key personnel
• To serve as unbiased observer and counsel to potential subjects and research teams on informed consent