Protocol Review and Monitoring System (PRMS)

基梅尔癌症中心(基梅尔癌症中心)的议定书审查和监测委员会是基梅尔癌症中心临床调查活动的一个组成部分。KCC PRMC审查了所有涉及人类受试者和肿瘤疾病的新研究提案。提案由相关疾病工作组进行预审查，工作组对方案的可行性、缺乏竞争性方案或与其他方案重叠时的分层以及与KCC的兼容性进行书面评估 研究和应计目标。临床研究管理办公室(CRMO)的工作人员为PRMC准备文件并协调会议和沟通。革命制度改革委员会的具体目标是(1)。建立一个由基础科学和临床领域的代表组成的KCC研究人员审查委员会，负责对所有正在进行的临床试验进行初步的科学审查和监测，(2)评估新提案的科学价值，(3)为相互竞争的KCC研究建立优先顺序的标准，(4)监测临床研究的收益，并及时终止那些未能达到基于方案规格的目标的研究，(5)与大学机构审查委员会和KCC数据和安全监测委员会保持合作关系，以促进三个审查委员会之间的互动，(6)通过审查CRMO进行的数据审计，确保议定书得到遵守。PRMC对每项拟议研究的初步科学审查集中在：(1)研究价值；(2)方法；(3)研究人员(S)的经验；(4)患者资源。预委会考虑以下其中一项 每项研究的五项行动：(1)书面批准，不需要修改；(2)仅批准咨询修改，不需要委员会进一步行动；(3)概念上批准，要求修改或理由；(4)提交研究人员补充意见/澄清；或(5)拒绝。防止酷刑委员会每月举行两次定期会议，讨论和评估提交KCC开放的涉及人类受试者的每一项议定书。研究人员发起的和行业赞助的方案要经过严格的全面科学同行审查，包括生物统计，以及药学、护理、财务和工作量审查。所有国家癌症研究所合作小组的协议都有资格接受快速审查，以确定实施的优先顺序。在2006年1月1日至2006年12月31日期间，提交了59项议定书供减贫战略委员会审查。在这些方案中，26个是合作组的；在其余的33个方案中，6个是外部同行审查的方案，14个是研究者发起的方案，13个是工业方案。在1/1/06-2/31/06期间，36项议定书获得批准并被激活，14项被推迟修订，16项获得批准但在这一时间范围内未被激活，7项最终被否决。

The Protocol Review and Monitoring Committee (PRMC) of the Kimmel Cancer Center (KCC) is an integral component of the KCC clinical investigations activities. The KCC PRMC reviews all new research proposals involving human subjects and neoplastic diseases. Proposals receive a pre-review by the pertinent disease-specific working group, which provides a written evaluation of protocol feasibility, lack of competitive protocols or stratification if overlap with other protocols exists, and compatibility with KCC research and accrual goals. The Clinical Research Management Office (CRMO) staff prepares the documentation and coordinates meetings and communications for the PRMC. The specific aims of the PRMC are to (1). Maintain a review committee of KCC investigators, with representation from basic science and clinical areas, responsible for the initial scientific review and monitoring of all ongoing clinical trials, (2) Evaluate the scientific merit of new proposals, (3) Establish criteria for prioritizing competing KCC studies, (4) Monitor accrual to clinical studies and terminate those studies that fail to meet objectives based on protocol specifications in a timely manner, (5) Maintain a collaborative relationship with the University Institutional Review Board and the KCC Data and Safety Monitoring Board (DSMB) to facilitate interaction between the three review committees, (6) Assure protocol compliance through the review of data audits conducted by the CRMO. The PRMC initial scientific review of each proposed study focuses on: (1) study value; (2) methods; (3) investigator(s) experience and (4) patient resources. The PRMC considers one of five actions for each study: (1) approved as written, no changes required; (2) approved with advisory changes only, no further committee action required; (3) approved in concept with changes or justification requested; (4) tabled for additional investigator input/clarification or (5) rejected. The PRMC holds regular meetings twice per month during which each protocol involving human subjects submitted to be opened at KCC is discussed and evaluated. Investigator-initiated and industry-sponsored protocols undergo rigorous full scientific peer review, including biostatisties, as well as pharmacy, nursing, financial and workload review. All National Cancer Institute cooperative group protocols are eligibl e to undergo expedited review to prioritize for implementation. In the period 1/1/06-12/31/06, 59 protocols were submitted for PRMC review. Of these, 26 were cooperative group; of the remaining 33 protocols, 6 were externally peer reviewed protocols, 14 were investigator initiated protocols and 13 were industrial protocols. In the period 1/1/06-2/31/06 36 protocols were approved and activated, 14 were deferred for revision, 16 were approved but not activated in this time frame, and 7 were ultimately disapproved.