University of Wisconsin–Madison

Research Subject Advocate

Role of the CRU Research Subject Advocates

The CRU Research Subject Advocates (RSAs) review all protocol applications submitted to the CRU Protocol Implementation Review group to ensure that the study complies with the Health Sciences Institutional Review Board approval. The RSAs also review all adverse event reports, unanticipated events, and protocol violations reported on CRU studies. The RSA and the CRU Nurse Manager also do daily “rounds” with CRU participants. To assist the RSAs in the review of applications, all CRU studies must complete an RSA Worksheet, which is part of the CRU Application.

PI Responsibilities
All required reporting to the study sponsor and the IRB (i.e., adverse events, unanticipated problems, protocol violations) should also be sent to the CRU RSA [via email to cruprotocoteam@uwhealth.org or via campus mail to D6/619, CSC (6736), attn: RSA]. All reports of events should not contain patient identifiable material, but instead have a study ID number or other identifying feature. For multicenter studies, any event report, which has led or may lead to the study being put on hold, should be immediately submitted to the CRU RSA. The CRU RSA should be informed within 48 hours of any events occurring in subjects on CRU protocols to ensure safe continuation of the protocol and allocation of any additional patient care resources required.

If your study requires a Data Monitoring Committee (DMC), review the information on the ICTR DMC page.