Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10358561
• 负责人: JAMES SPEYER
• 金额: $ 5.42万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10358561
• 关键词: Agreement; Amendment; Cancer Center; Cancer Center Support Grant; Catchment Area; Charge; Clinical Research; Clinical Trials; Ensure; Environmental Health; Funding; Goals; Guidelines; Health; Institutional Review Boards; Investigation; Malignant Neoplasms; Monitor; Peer Review; Pharmacy facility; Policies; Process; Protocols documentation; Research; Research Personnel; Safety; Science; System; Time; United States National Institutes of Health; Woman; authority; design; environmental radiation; human subject; minority children; sound

Project Summary Protocol Review and Monitoring System (PRMS) The Perlmutter Cancer Center (PCC) Protocol Review and Monitoring System (PRMS), internally known as the Protocol Review and Monitoring Committee (PRMC), reviews all cancer-related clinical research under the jurisdiction of PCC and NYU Langone Health (NYULH). The objectives of the PRMC are to determine whether a protocol is scientifically and statistically sound, appropriately designed, feasible and not competitive with other ongoing studies at PCC. The PRMC also determines if protocols are aligned with PCC scientific priorities and the needs of our catchment area, evaluates whether accrual goals are realistic, and assesses the likelihood of trial completion. The PRMC has the ultimate authority to approve and prioritize, in an efficient and timely manner, the activation of cancer-related protocols that have a high level of scientific merit and meet the scientific priorities of the PCC. The PRMC also decides whether to terminate protocols that do not demonstrate acceptable progress. Investigator-initiated studies are reviewed for progress at least bi-annually, and other studies annually. All studies are reviewed more frequently if deemed necessary by the PRMC, due to low accrual or if protocol amendments significantly change the scientific design or accrual targets of the protocol. The PRMC is also charged with ensuring that all cancer-related clinical research at NYULH meets appropriate criteria for inclusion of women, minorities and children. The PRMC is fully integrated into the clinical trials review and approval systems of NYULH. In this context, it functions in a well-coordinated, expeditious, but non-overlapping manner with the NYULH IRB, Office of Science and Research (OSR), and various other NYULH review entities, including Environmental Health and Radiation Safety, Biosafety, and Investigational Pharmacy. Consistent with the Institutional agreement with the NCI, the NYULH IRB will not grant full approval to any cancer-related human subjects protocol without receiving documentation of PRMC approval.

项目摘要 方案审查和监测系统（PRMS） Perlmutter癌症中心（PCC）方案审查和监测系统（PRMS），内部称为 方案审查和监测委员会（PRMC）审查所有与癌症相关的临床研究， PCC和NYU Langone Health（NYULH）的管辖权。PRMC的目标是确定 方案在科学上和统计学上是否合理，设计是否适当，是否可行，是否具有竞争性 与PCC正在进行的其他研究。PRMC还确定方案是否符合PCC科学 优先事项和我们的服务区的需求，评估是否应计目标是现实的，并评估 完成审判的可能性。PRMC拥有最终批准权和优先权， 及时启动具有高度科学价值并符合 PCC的科学优先事项。PRMC还决定是否终止未证明 可接受的进展。研究者发起的研究至少每两年审查一次进展，其他 每年研究。如果PRMC认为有必要，所有研究都将更频繁地进行审查， 如果方案修订案显著改变了方案的科学设计或应计目标， PRMC还负责确保NYULH的所有癌症相关临床研究符合适当的 纳入妇女、少数民族和儿童的标准。PRMC完全融入临床试验 NYULH的审查和批准系统。在这方面，它以一种协调良好、迅速但 与NYULH IRB，科学和研究办公室（OSR）以及其他各种机构的非重叠方式 NYULH审查实体，包括环境健康和辐射安全、生物安全和研究 去的.根据与NCI的机构协议，NYULH IRB将不会授予完全批准 任何癌症相关人类受试者方案，而无需收到PRMC批准文件。