Protocol Review and Monitoring System

摘要-方案审查和监测系统 杜克癌症研究所的方案审查和监测系统（PRMS）福尔斯属于 癌症议定书委员会（CPC）。方案协调会负责执行方案审查和管理系统 职能，包括评估符合DCI定义的所有研究的科学价值和进展 “癌症相关”虽然CPC在方案审查期间坚持科学严谨性和完整性的标准 在这一过程中，它还通过提供必要的资源， 教育通过履行其科学监督责任，CPC确保DCI调查人员进行 高质量和有影响力的临床研究，符合DCI的研究重点，并满足以下需求： 癌症患者社区。此外，CPC与临床疾病组和DCI密切合作， CCSG研究计划在临床试验的优先顺序进行审查。 CPC是一个科学同行评审委员会，由40名有投票权的成员组成， 多学科临床研究企业选择CPC成员是为了确保多样化 与癌症临床研究相关的专业知识，由临床研究者、研究者、 药剂师、生物统计学家、翻译博士科学家和患者倡导者。所有与癌症相关的方案 在激活前由CPC批准，并且批准的研究仍对入组开放， CPC自研究启动后每6个月进行一次持续审查。审查的研究包括干预性研究 （治疗、预防、支持、诊断）和非干预（辅助、相关[基于组织]， 观察）研究。此外，对癌症相关研究的修订进行了前瞻性评估， 经CPC审查。 CPC批准了精心设计的研究，这些研究有可能对癌症护理产生积极影响， 有权终止未能证明有意义进展或因转移而失去相关性的研究 癌症研究和癌症患者护理的范例。在上一个项目期间，方案协调会共审查了 1，316项新议定书，918项年度更新和322项修正案。

ABSTRACT – PROTOCOL REVIEW AND MONITORING SYSTEM Duke Cancer Institute’s Protocol Review and Monitoring System (PRMS) falls within the scope of responsibility of the Cancer Protocol Committee (CPC). The CPC is responsible for implementation of the PRMS function, including evaluating the scientific merit and progress of all studies that meet the DCI definition of “cancer-related”. While the CPC upholds standards in scientific rigor and integrity during the protocol review process, it also helps investigators and study teams attain such standards by providing essential resources and education. By meeting its scientific oversight responsibilities, the CPC ensures that DCI investigators conduct high quality and impactful clinical research that aligns with the DCI’s research priorities and meets the needs of the cancer patient community. In addition, the CPC works closely with the clinical Disease Groups and DCI CCSG Research Programs in the prioritization of clinical trials for review. The CPC is a scientific peer-review committee comprised of 40 voting members that reflect the multidisciplinary clinical research enterprise at the DCI. The CPC membership is selected to ensure diverse expertise relevant to cancer clinical research and is composed of clinical investigators, investigational pharmacists, biostatisticians, translational PhD scientists, and patient advocates. All cancer-related protocols are approved by the CPC prior to activation and approved studies that remain open to enrollment must undergo continuing review by the CPC every six months from study activation. Studies reviewed include interventional (treatment, preventive, supportive, diagnostic) and non-interventional (ancillary, correlative [tissue-based], observational) studies. In addition, amendments to cancer-related studies are prospectively assessed and reviewed by the CPC. The CPC approves well-designed studies that hold the potential to positively affect cancer care and has the authority to terminate studies that fail to demonstrate meaningful progress or lose relevance due to shifting paradigms of cancer research and cancer patient care. During the past project period, CPC reviewed a total of 1,316 new protocols, 918 annual renewals, and 322 amendments.