Protocol Review and Monitoring System

摘要--协议审查和监测系统 指导和监督临床试验的生命周期和参与者的安全是通过以下方式实现的 在研究发展、审查和绩效方面有明确的流程。除了重要的角色外， 首席研究员、副研究员(S)、研究组(S)、圣犹大综合癌症中心 (SJCCC)计划这一努力，临床试验科学审查委员会(CT-SRC)是 这一过程。CT-SRC负责协议审查和监测系统(PRMS)。CT-SRC 审查所有新的前瞻性临床试验，这些试验首先在相关的SJCCC计划中讨论 以确保它们与各自计划的科学目标保持一致。如果是这样的话，试验的优先顺序是 该计划的其他相互竞争的协议。在方案审查和认可之后，CT-SRC审查 科学的理论基础，可行性，研究和生物统计设计，并监督所有 确保遵循初始研究设计、及时应计和停止标准的机构方案 而且病人的安全也得到了保障。此外，CT-SRC有权修改研究的进行 并根据需要关闭它们。委员会成员包括具有临床研究、肿瘤学专业知识的个人 学科、生物统计学和翻译科学。2012年7月，CT-SRC实施了一项概念 提交和审查流程应先于完整的协议制定。期间所做的其他更改 资助期包括采用正式的审查员工作表，以侧重于基本审查标准和 改进文件编制工作，正式确定国家工作队监测应计项目的政策，加强 委员会的成员，包括更多的高级研究人员，并实施后期效应和 行为研究小组委员会。中央礼宾和数据监测办公室的工作人员协助校长 调查人员向审查委员会提交电子意见书，并为CT-SRC准备文件。 他们还协调调查人员与反恐特别委员会之间的会议和沟通。电脑断层扫描- SRC独立于圣犹大机构审查委员会和安全监督程序(即 外部数据安全和监测委员会和内部监测委员会)。2015财年- 2017财年，CT-SRC审查并批准了109项新的癌症研究的优先顺序，并审查了73项 概念。62项新研究(57%)是由SJCCC研究人员发起的外部同行评议试验。 在109项审查的研究中，有8项(7%)是不获批准或提交的。在同一时期，CT-SRC监测到 382项关于应计项目的研究，775项关于科学进步的研究，包括接近应计项目但尚未完成的研究。 在同一时期，75项研究被关闭，其中8项是因为收益低。总而言之，PRMS 评估和监督所有预期的临床试验的科学价值和与 SJCCC，确保议定书的目标有望在估计的时间框架内完成，以及 决定了它们与同时代科学的相关性。

ABSTRACT–Protocol Review and Monitoring System The conduct and oversight of the lifecycle of clinical trials and the safety of participants are achieved through well-defined processes in study development, review, and performance. In addition to the important roles of the principal investigator, sub-investigator(s), research team(s), and the St. Jude Comprehensive Cancer Center (SJCCC) programs to this endeavor, the Clinical Trials Scientific Review Committee (CT-SRC) is at the core of this process. The CT-SRC is charged with the Protocol Review and Monitoring System (PRMS). The CT-SRC reviews all new prospective clinical trials, which have been first discussed within the pertinent SJCCC Program to ensure that they are aligned with the respective Program's scientific goals. If so, the trial is prioritized among the Program's other competing protocols. After programmatic review and endorsement, the CT-SRC reviews the scientific rationale, feasibility, and study and biostatistical designs and oversees the progress of all institutional protocols to ensure that the initial study design, timely accruals, and stopping criteria are followed and that patient safety is maintained. In addition, the CT-SRC is empowered to modify the conduct of studies and close them, as needed. Committee members include individuals with expertise in clinical research, oncology disciplines, biostatistics, and translational sciences. In July 2012, the CT-SRC implemented a Concept Submission and Review process to precede full protocol development. Additional changes made during the funding period include adopting a formal reviewer worksheet to focus the fundamental review criteria and improve documentation, formalizing a policy for accrual monitoring by the CT-SRC, strengthening the committee's membership with inclusion of additional senior researchers, and implementing the Late Effects and Behavioral Research Subcommittee. Staff in the Central Protocol and Data Monitoring Office assist principal investigators with electronic submissions to the review committees and prepare documents for the CT-SRC. They also coordinate the meetings and communications between the investigators and the CT-SRC. The CT- SRC acts independently of the St. Jude Institutional Review Board and the safety oversight processes (i.e., the external Data Safety and Monitoring Board and the Internal Monitoring Committee). During fiscal year (FY) 2015– FY2017, the CT-SRC reviewed and approved the prioritization of 109 new cancer studies and reviewed 73 concepts. Sixty-two (57%) of the new studies were SJCCC investigator–initiated, externally peer-reviewed trials. Of the 109 studies reviewed, 8 (7%) were disapproved or tabled. During this same period, the CT-SRC monitored 382 studies for accrual and 775 for scientific progress, including studies closed to accrual but not yet completed. During this same period, 75 studies were closed, 8 of which because of low accrual. In summary, the PRMS evaluates and monitors all prospective clinical trials for scientific merit and alignment with the goals of the SJCCC, ensures that the aims of the protocols are on track for completion within the estimated time frames, and determines their relevance to contemporaneous science.