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DATA AND SAFETY MONITORING Introduction This document is developed to provide guidelines for Data and Safety Monitoring (DSM) plans, which are a required element of every research protocol conducted on the University of Wisconsin General Clinical Research Center (UW-GCRC). The Research Subject Advocate (RSA), mandated by NIH, is responsible for ensuring that the Proposal Review Committee-approved DSM plans are fully implemented. The Advocate is also responsible for ensuring that GCRC research protocols are in compliance with the Institutional Review Board (IRB) approval, and that adverse events are reported appropriately to the IRB, federal agencies, the sponsor, and to other agencies. The GCRC views the safety of patients and subjects participating in clinical studies as its highest priority. All GCRC studies must have an appropriate DSM plan.
Every study conducted or supported through the GCRC must include a DSM plan. These plans may vary, depending on degree of risk, number of subjects, and complexity of the study. The DSM plan developed by the principal investigator (PI) will be reviewed and approved by the IRB and the GCRC Advisory Committee (GAC). A photocopy of the DSM plan must be included in the GCRC submission. Protocols that are deemed moderate to high risk by the GAC 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 GCRC documentation. For low-risk studies, without an outside DSM Board, the GCRC will provide supervision through the RSA and the GCRC DSM Committee. All DSM plans must state how each study will be monitored. They should include a mechanism for reporting the number of patients or subjects entered and treated, summary of unexpected adverse events, a specific list of adverse events requiring expedited reporting, and procedures for dealing with Serious Adverse Events (Events). Significant literature pertinent to safety issues should also be submitted to the RSA. 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. All Events occurring with GCRC protocols must promptly be reported to the Research Subject Advocate, any DSM Board involved, the IRB, and the study sponsor.
The PI of each study is responsible for ensuring that his or her protocol includes a DSM plan as outlined above. The DSM plan should be submitted to the Proposal Review Committee, to the IRB, and to the sponsor. All required reporting to the sponsor of the study and the IRB should be sent to the RSA. DSM plans must also include a description of the reporting mechanism of adverse events to the IRB, FDA, NIH, and other sponsors. PIs must ensure that all these organizations and the RSA are informed of actions taken by the IRB as a result of its continuing review. 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 Research Subject Advocate, who will forward them to the Proposal Review Committee and, as appropriate, to the GCRC DSM Committee. The RSA needs to know, within 48 hours, any Events occurring in subjects on GCRC protocols to ensure safe continuation of the protocol and allocation of any additional patient care resources required.
The two RSA's, Yoram Shenker, MD, and Margo Hoover-Regan, MD, review all protocols that go to the GCRC Advisory Committee. The RSA's work with the PIs, study coordinators, and GCRC nurses to ensure that GCRC research is conducted in compliance with IRB and GCRC approvals. Drs. Shenker and Hoover-Regan review all adverse event reports. PIs utilizing the GCRC for studies are responsible for providing adverse event reports to Data Safty Monitoring Committee meetings. Dr. Shenker chairs the GCRC DSM Committee, which meets once every two months. The RSA's are responsible for ensuring that all the appropriate reports are discussed by the DSM Committee. Drs. Shenker and Hoover-Regan are available to current and potential GCRC investigators who need consultation in data and safety monitoring. Contact Dr. Shenker at yxs@medicine.wisc.edu, and Dr. Hoover-Regan at mhooverregan@wisc.edu The GAC is responsible for the review and approval of the DSM plans for all GCRC studies. The Committee also reviews reports of adverse events submitted through the Advocate and /or GCRC DSM Committee. Click on the following links to download the forms you would like:
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