Protocol Review and Monitoring System: |
OverviewThe Cancer Center Protocol Review and Monitoring System was established in 1994 as a required component of the National Institutes of Health Clinical Cancer Center at the University of Virginia. The role of the PRMS is to review all studies involving patients with cancer that have not received a NIH or equivalent peer review. NIH-equivalent peer reviews would include those by the American Cancer Society, Department of Defense, or National Science Foundation. In practice, the Committee reviews all studies involving patients with cancer that are sponsored by drug companies and in-house studies. The Committee does not provide a formal review of Cooperative Group protocols (COG, RTOG, ECOG, NSABP, ACOSOG, and Coalition of National Cancer Cooperative Groups) because these studies have already received an exhaustive peer review by the National Cancer Institute through its Cancer Therapy Evaluation Program (CTEP) Branch. Scope: The Committee must review all protocols involving patients with a cancer diagnosis. Thus, the Committee needs to review therapeutic and non-therapeutic protocols alike. At this particular time, the Committee does not review protocols involving cancer screening (of patients who do not have a cancer diagnosis). In the future, the Committee will seek NIH guidance on this issue if the Cancer Center moves to Comprehensive status. Review procedures1. All pharmaceutical or investigator-initiated protocols involving patients with cancer should receive a review by the PRC. NIH cooperative group protocols do not have to undergo review by the PRC. 2. The PRC meets on the third Monday of each month. The deadline for submission is the first Monday of the month. Click here to see a list of 2007 deadlines and meeting dates. Submission forms may be downloaded above, or e-mail for a form. Principal investigators are encouraged to submit their protocols and data safety plans electronically, in order to avoid the necessary 17 paper copies. 3. Protocols are reviewed by the Chair to determine if they require Committee review or have already received an NIH/NCI peer review. Protocols may not have access to Cancer Center Clinical Trials Office resources or be submitted to the IRB-HSR until they are revised, reviewed, and approved. 4. The PRC will provide the outcome of its written review to the investigator in the form of a letter. The investigator is encouraged to attend the meeting at which his or her protocol is under review. 5. Submission to the Institutional Review Board for Health Sciences Research will require a final approval letter from the PRC Chair.
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