PRMS

协议审查监测系统

Protocol Review Monitoring System The goal of the Protocol Review and Monitoring System (PRMS) is to promote the conduct of scientifically meritorious clinical research under the aegis of the UCSD Cancer Center. The mechanism for accomplishing this is the establishment of a Protocol Review and Monitoring Committee (PRMC). The PRMC is a multidisciplinary standing committee of the Moores Cancer Center. Its charge is the scientific peer review of research studies involving patients with cancer that are conducted at UCSD or its affiliate institutions, the Veterans Administration Healthcare System San Diego and Children's Hospital San Diego. To provide this oversight function, the PRMC has the following Specific Objectives: (1) perform scientific peer review of cancer-related clinical and translational research protocols to be conducted at UCSD and affiliate institutions; (2) approve a priority designation for new cancer clinical protocols in coordination with leaders of the Cancer Center's disease-focused Specialized Cancer Units; (3) review the scientific progress of active clinical protocols through annual evaluation of subject accrual data; and (4) review in real-time those serious and unexpected adverse events that meet criteria for reporting to the UCSD Institutional Review Board (IRB). The PRMC is granted authority by the Cancer Center Director to approve the initiation and continuation of clinical cancer research protocols, or to recommend their termination according to defined review and monitoring criteria. In concert with these scientific review and monitoring functions, the PRMC directly informs the UCSD IRB of relevant scientific and subject safety issues for complementary review by that committee of cancer-related research submitted for activation at UCSD and affiliate institutions. Both the PRMC Chair and Vice Chair are members of the UCSD IRB, and approval by PRMC is required for the activation of cancer-related research at UCSD and its affiliates. In achieving its scientific review and monitoring objectives, the PRMC ensures that Cancer Center resources are effectively utilized to foster clinical cancer research that is of high scientific quality and importance.