CTRC Data & Safety Monitoring
The CTRC Research Subject Advocate (RSA) is responsible for ensuring that CTRC research protocols comply with the Health Sciences Institutional Review Board (HS-IRB) approval, and that adverse events are reported appropriately to the IRB, federal agencies, the sponsor, and to other agencies. All CTRC studies must also complete the CTRC Data and Safety Monitoring Plan template.
Data and Safety Monitoring Policy for the UW-CTRC
Every study conducted or supported through the CTRC must complete the CTRC Data and Safety Monitoring Plan (DSMP) [doc]. A CTRC DSMP must be included in the CTRC submission. Protocols that are deemed moderate to high risk by the RSA must also have a Data and Safety Monitoring Board.
PIs working with an outside DSM Board (such as the Cancer Center DSM Board or Study Sponsor Board) need only ensure that the Advocate receives all reports to and from the DSM Board to maintain CTRC documentation. For low-risk studies, without an outside DSM Board, the CTRC will provide supervision through the RSA and the CTRC Data and Safety Monitoring Committee (DSMC).
Data and safety monitoring will continue for each study until it is completed and all patients or subjects are beyond the time point when adverse events are expected. The Research Subject Advocates, and DSMC will review every CTRC protocol at least once annually. All Events occurring with CTRC protocols must promptly be reported to the Research Subject Advocate, any DSM Board involved, the IRB, and the study sponsor.
PI's Responsibilities.
All required reporting to the sponsor of the study and the IRB also should be sent to the CTRC, D6/621, attention: RSA. All reports of Events must have no patient identifiable material on them. Instead, they should have a study ID number or other identifying feature.
The PI is responsible for submission of expedited reports of Events to the RSA. For multicenter studies, any Event report, which has lead or may lead to the study being put on hold, should be immediately submitted to the CTRC Research Subject Advocate, who will forward them to the CTRC Review Committee (formerly GAC) and, as appropriate, to the CTRC DSMC.
The RSA needs to know, within 48 hours, any Events occurring in subjects on CTRC protocols to ensure safe continuation of the protocol and allocation of any additional patient care resources required.
Research Subject Advocate (RSA) Roles
The two RSAs, Yoram Shenker, MD, and Margo Hoover-Regan, MD, review all protocols that go to the CTRC Review Committee. The RSAs work with the PIs, study coordinators, and CTRC nurses to ensure that research is conducted in compliance with IRB and CTRC approvals.
Drs. Shenker and Hoover-Regan review all adverse event reports. PIs utilizing the CTRC for studies are responsible for providing adverse event reports, unanticipated events, and protocol violations to the RSA, D6/6, in the CTRC.
Dr. Shenker chairs the DSMC, which meets once every two months. The RSAs are responsible for ensuring that all the appropriate reports are discussed by this committee.
Drs. Shenker and Hoover-Regan are available to current and potential CTRC investigators who need consultation in data and safety monitoring. Contact Dr. Shenker at
, and Dr. Hoover-Regan at
