Core 017 (502) Protocol Review and Monitoring System

项目摘要 MCC方案审查和监测系统（PRMS）对以下方面的科学方面进行内部监督： 所有临床试验。这包括全权开启、关闭和确定所有 问题研究为了进行PRMS流程，MCC利用四个科学审查委员会（SRC）， 工作人员协调员PRMS在过去三年中处理了500多份初步审查协议 年从提交到全面审查的平均时间约为20天。委员会 协调员审查提交的材料的完整性，并与研究小组合作， 科学审查进程所需的补充资料。在审查了完整的信息后， 协调员评估方案，以确定 如果它有资格快速审查或需要一个完整的SRC委员会审查。如果协调员认为研究 有资格进行快速审查（例如，NCI、NCTN或ETCTN），协调员将研究发送给确认人员 和认可如果研究需要进行全面的委员会审查，协调员将在下一次会议上安排研究 开放式议程。四个SRC在整个月都安排了会议，以确保及时 审查. PRMS还审查所有研究修正案。变更研究目的的修订， 结果测量或研究人群，以及其他重大变化被发送到完整的SRC委员会进行审查。 PRMS在2015财年处理了500多项研究修正案，其中100项需要SRC委员会进行全面审查。 PRMS还负责监测所有MCC研究的科学进展。监测研究 每六个月一次这些研究大大低于他们的 预计的应计比率被标记为在SRC董事会全体会议上讨论。届时，董事会将审查 研究进展以及PI的解释和纠正措施计划，以确定研究是否 很有可能实现其应计目标。如果SRC确定研究将不符合招募目标或不再 科学上重要，则SRC关闭研究。 PRMS的具体目标如下： ·目标1：建立和维持一个规模和专业知识广度足够的审查委员会， 对涉及人类受试者的癌症相关研究方案进行批判性和公正的科学审查 目标2：对MCC进行的所有癌症相关临床方案进行彻底的科学审查 根据具体的、预先确定的审查标准 目标3：优先考虑所有MCC临床试验 目标4：监测正在进行的临床试验的科学进展

PROJECT SUMMARY The MCC Protocol Review & Monitoring System (PRMS) provides internal oversight of the scientific aspects of all clinical trials. This includes full authority for opening, closing, and determining appropriate prioritization of all studies. To conduct PRMS processes, MCC utilizes four Scientific Review Committees (SRCs) supported by staff coordinators. The PRMS has processed more than 500 protocols for initial review over the past three years. The average time from submission to full board review is approximately 20 days. Committee coordinators review the materials submitted for completeness and work with the study team to acquire any additional information needed for the scientific review process. Upon review of the complete information package (protocol, investigational brochure, and surveys), the coordinator evaluates the protocol to determine if it qualifies for expedited review or requires a full SRC board review. If the coordinator believes the study qualifies for expedited review (e.g., NCI, NCTN, or ETCTN), the coordinator routes the study for confirmation and approval. If the study requires a full board review, the coordinator will schedule the study on the next available open agenda. The four SRCs have meetings scheduled throughout the month to ensure a timely review. The PRMS also reviews all amendments to studies. Amendments that change study objectives, outcome measures or the study population, and other major changes are sent to full SRC board for review. The PRMS processed over 500 amendments to studies in FY15 with 100 requiring a full SRC board review. The PRMS is also responsible for monitoring the scientific progress of all MCC studies. Studies are monitored at each six-month anniversary of their activation date. Those studies that significantly fall below their anticipated accrual rate are flagged for discussion at the full SRC board. At that time, the board reviews the progress of the study and also the explanation and corrective action plan from the PI to determine if the study is likely to meet its accrual goal. If the SRC determines the study will not meet the accrual goal or is no longer scientifically important, then the study is closed by the SRC. The specific aims of the PRMS are as follows: • Aim 1: Establish and maintain a review committee of sufficient size and breadth of expertise to conduct a critical and fair scientific review of cancer-related research protocols involving human subjects • Aim 2: Conduct a thorough scientific review of all cancer-related clinical protocols conducted at the MCC based on specific, pre-determined review criteria • Aim 3: Prioritize all MCC clinical trials • Aim 4: Monitor scientific progress for ongoing clinical trials