Protocol Review and Monitoring System

议定书审查和监测系统.摘要 方案审查和监测系统(PRMS)监督所有与癌症相关的临床研究 斯蒂芬森癌症中心(SCC)，包括俄克拉荷马医学研究基金会的临床研究 (SCC提议的财团合作伙伴)，为了确保它具有最高的科学价值，坚持 SCC的战略优先事项，显示了持续的进展，并有效地利用了SCC资源。这个 PRMS分两个阶段进行协议审查。在第一阶段，多学科疾病-网站 委员会(MDC)发起和/或审查成员调查人员提出的方案(如果基于疾病) 为了评估科学价值，相关患者群体的可用性，与潜在的竞争重叠 试验以及方案是否与疾病现场计划目标一致。争取民主变革运动还协助调查人员 制定由调查者发起的试验(IITs)。SCC预算和业务委员会(BOC)，该委员会 由临床试验办公室(CTO)和SCC管理核心的领导层组成，审查所有新的 确保有效利用首席技术官资源、业务可行性和适当性的体制方案 成本分配的问题。在第二阶段，议定书审查和监测委员会进行了 对议定书进行独立审查，以评估科学价值和设计可行性。SCC总监已 授予PRMC机构权力，以开放符合SCC标准的方案以实现科学价值 和科学优先事项，并终止不能证明科学进步的议定书。 PRMC成员包括来自多个从事癌症临床的学科的广泛代表 研究。它的21名有投票权的成员是根据他们特定学科的知识、经验和 设计和进行研究研究，和/或专门的临床专业知识。根据试验类型， PRMC执行快速行政审查或全面委员会审查。如果是后者，至少有两个 来自PRMC投票成员的审查员被分配到该方案。议定书以多数票通过。 法定人数成员的表决。PRMC审查在提交给机构审查委员会之前进行 (IRB)，根据机构政策，后者将不会审查与癌症有关的方案，直到获得 PRMC。2016年，PRMC审查了114项新议定书。PRMC还每年监控活动协议，以 正在进行的累积，并有权关闭没有证明充分的科学进步的议定书。 一个旨在提高低登记试验应计利润的重点程序也是减贫方案的一部分。2016年， PRMC审查了73项有效的累积进展议定书。其中，41家获准继续运营，27家 需要提交应计改进计划，5个因应计利润较低而关闭。

PROTOCOL REVIEW AND MONITORING SYSTEM – ABSTRACT The Protocol Review and Monitoring System (PRMS) oversees all cancer-related clinical research at the Stephenson Cancer Center (SCC), including clinical research at the Oklahoma Medical Research Foundation (the SCC's proposed consortium partner), in order to ensure that it is of the highest scientific merit, adheres to the strategic priorities of the SCC, demonstrates ongoing progress and efficiently utilizes SCC resources. The PRMS conducts protocol review in a two-stage process. In stage one, Multidisciplinary Disease-Site Committees (MDCs) initiate and/or review protocols (when disease-based) proposed by member investigators in order to assess scientific merit, availability of relevant patient population, overlap with potentially competing trials and whether protocols align with disease-site program goals. The MDC also assists investigators in the development of investigator-initiated trials (IITs). The SCC's Budget and Operations Committee (BOC), which is comprised of the leadership of the Clinical Trials Office (CTO) and SCC Administrative Core, reviews all new institutional protocols to ensure effective CTO resource utilization, operational feasibility and appropriateness of cost allocation. In stage two, the Protocol Review and Monitoring Committee (PRMC) conducts an independent review of the protocol to assess scientific merit and design feasibility. The SCC Director has delegated to the PRMC the institutional authority to open protocols that meet SCC standards for scientific merit and scientific priorities and to terminate protocols that do not demonstrate scientific progress. PRMC membership includes broad representation from multiple disciplines engaged in cancer clinical research. Its 21 voting members are selected based on their disciplinary-specific knowledge, experience in designing and conducting research studies, and/or specialized clinical expertise. Depending on trial type, the PRMC performs either an expedited Administrative Review or Full Committee Review. If the latter, at least two reviewers from the PRMC voting members are assigned to the protocol. A protocol is approved with a majority vote of a quorum of members. PRMC review occurs prior to submission to the Institutional Review Board (IRB), and per institutional policy the latter will not review cancer-related protocols until approved by the PRMC. In 2016, the PRMC reviewed 114 new protocols. The PRMC also monitors active protocols annually for ongoing accrual and has the authority to close protocols that do not demonstrate adequate scientific progress. A focused process designed to enhance accrual to low enrolling trials is also part of the PRMC. In 2016, the PRMC reviewed 73 active protocols for accrual progress. Of these, 41 were approved to continue, 27 were required to submit Accrual Enhancement Plans, and five were closed due to low accrual.