Protocol Review and Monitoring System

协议审查监控系统 方案审查和监测系统(PRMS)的目标是促进在加州大学圣地亚哥分校癌症中心的支持下进行具有科学价值的临床研究。实现这一目标的机制是设立议定书审查和监测委员会(PRMC)。PRMC是摩尔癌症中心的一个多学科常设委员会。它负责对加州大学圣地亚哥分校或其附属机构、圣地亚哥退伍军人管理局医疗系统和圣地亚哥儿童医院进行的涉及癌症患者的研究进行科学同行审查。要提供这一点 为了履行监督职能，癌症预防控制中心有以下具体目标：(1)对将在加州大学圣迭戈分校及其附属机构进行的癌症相关临床和转化性研究方案进行科学同行审查；(2)与癌症中心以疾病为重点的专科癌症单位的领导协调，批准新的癌症临床方案的优先指定；(3)通过对受试者应计数据的年度评估，审查现行临床方案的科学进展；以及(4)实时审查符合向加州大学圣迭戈分校机构审查委员会(IRB)报告标准的严重和意外不良事件。癌症研究中心主任授权PRMC批准临床癌症研究方案的启动和继续，或根据定义的审查和监测标准建议终止这些方案。与这些科学审查和监测职能相一致，PRMC直接向UCSD IRB通报相关的科学和受试者安全问题，供该委员会对提交给UCSD及其附属机构启动的与癌症相关的研究进行补充审查。PRMC主席和副主席都是UCSD IRB的成员，在UCSD及其附属机构启动与癌症相关的研究需要得到PRMC的批准。在实现其科学审查和监测目标的过程中，PRMC确保癌症中心的资源得到有效利用，以促进具有高科学质量和重要性的临床癌症研究。

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.