Protocol Review and Monitoring System (PRMS)

协议审查和监测系统 基梅尔癌症中心(KCC)的礼宾审查和监测委员会(PRMC)是 KCC临床调查活动的组成部分。KCC PRMC审查所有新研究 涉及人体主题和肿瘤疾病的提案。提案将由 相关的特定疾病工作组，提供对议定书可行性的书面评估，缺乏 竞争性协议或分层(如果与其他协议重叠)以及与KCC的兼容性 研究和应计目标。临床研究管理办公室(CRMO)的工作人员准备 为PRMC提供文件并协调会议和沟通。《公约》的具体目标 PRMC为(1)。维持一个由KCC调查人员组成的审查委员会，其中有基础科学的代表 和临床领域，负责对所有正在进行的临床试验进行初步科学审查和监测，(2) 评估新提案的科学价值，(3)为相互竞争的KCC研究确定优先顺序的标准， (4)监测临床研究的应计费用，并终止那些未能达到目标的研究 及时制定协议规范，(5)与校方保持协作关系 机构审查委员会和KCC数据和安全监测委员会(DSMB)，以促进互动 在三个审查委员会之间，(6)通过审查数据审计确保遵守协议 由CRMO进行。PRMC对每项拟议研究的初步科学审查侧重于：(1)研究 价值；(2)方法；(3)调查员(S)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)以书面形式批准，无需更改；(2)以咨询方式批准 仅更改，不需要委员会采取进一步行动；(3)概念上已获批准，但有更改或理由 要求；(4)提交调查人员补充意见/澄清，或(5)被拒绝。临立会定期举行 每月举行两次会议，在此期间，每个涉及人类受试者的礼仪都将在 对KCC进行了讨论和评价。研究人员发起的和行业发起的协议经过严格的 全面的科学同行审查，包括生物统计以及药学、护理、财务和工作量 复习一下。所有国家癌症研究所合作小组的方案都有资格接受快速审查 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。 在这些议定书中，26个是合作小组；在其余33个议定书中，6个是外部同行审查的 协议，14个是研究人员发起的协议，13个是工业协议。在1/1/06期间- 2/31/06 36个方案获得批准并被激活，14个方案被推迟修订，16个方案获得批准但没有 在这段时间内被激活，最终有7人被否决。

PROTOCOL REVIEW AND MONITORING SYSTEM 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.