PROTOCOL REVIEW AND MONITORING SYSTEM (Core-016)

方案审查和监测系统（Core-016）

• 批准号: 9118151
• 负责人: STACEY L BERG
• 金额: $ 6.25万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9118151
• 关键词: Cancer Center; Cancer Control; Cancer Therapy Evaluation Program; Cell Therapy; Clinic; Clinical Research; Clinical Research Protocols; Clinical Trials; Concept Review; Data; Data Reporting; Descriptor; Doctor of Medicine; Ensure; Epidemiologic Studies; Funding; Funding Mechanisms; General Hospitals; Hospitals; Industry; Institution; Institutional Review Boards; Leadership; Malignant Neoplasms; Medicine; Methodist Church; Monitor; Observational Study; Pediatric Hospitals; Peer Review; Policies; Process; Protocols documentation; Reporting; Research; Research Personnel; Review Committee; Safety; System; Texas; Therapeutic; Time; United States National Institutes of Health; Veterans Hospitals; Voting; authority; base; cancer clinical trial; cancer prevention; college; expedited review; gene therapy; meetings; member; prevention clinical trial; programs; working group

CORE: Protocol Review and Monitoring System (PRMS) PROJECT SUMMARY The Dan L. Duncan Cancer Center (DLDCC) has established the Protocol Review and Monitoring Committee (PRMC) to provide systematic internal oversight of the scientific and research aspects of all cancer-related therapeutic and prevention clinical trials conducted in DLDCC affiliated institutions. By BCM and DLDCC policy, the PRMC has authority to approve and close all DLDCC clinical research protocols. Chaired by Stacey Berg, M.D., the PRMC is organized into an Executive Committee and three working groups, with a total of 44 voting members. The PRMC assigns each protocol a scientific merit score of 1-9 according to standard NIH review descriptors. In addition, a DLDCC priority score of High, Medium, or Low is assigned to aid protocol prioritization. Studies that have been approved by the NCI Cancer Therapy Evaluation Program (CTEP) or Cancer Prevention and Control Protocol Review Committee or that are supported by an NIH funding mechanism that required full peer review as part of the funding process undergo an expedited administrative review. The PRMC also monitors progress and accrual of active studies. At the time of each open protocol’s annual IRB review, or more frequently if deemed necessary, the PRMC conducts a full review to ensure that adequate scientific progress is being made. In addition, the PRMC reviews the accrual to all the open protocols in each Program on a quarterly basis. The PRMC functions in a complementary but not duplicative way with the IRB and the Data Safety Monitoring Committees. The PRMC provides reports to the Clinical Research Leadership Committee, which also receives reports from the Data Safety Monitoring Committees, thus ensuring that activities of these two separate entitles are integrated. From 2011 to 2013, the PRMC reviewed an average of 44 new submissions per year, including 10 investigator-initiated institutional, 19 National Group, 3 other externally peer reviewed, and 12 industry sponsored protocols. An average of 140 annual reviews of ongoing progress were also performed each year.

核心：方案审查和监控系统（PRMS） 项目概要 Dan L. Duncan 癌症中心 (DLDCC) 成立了方案审查和监测委员会 (PRMC) 对所有癌症相关的科学研究方面提供系统的内部监督 由 BCM 和 DLDCC 在 DLDCC 附属机构进行治疗预防和临床试验。 根据政策，PRMC 有权批准和关闭由 Stacey 主持的所有 DLDCC 临床研究方案。 Berg, M.D. 表示，PRMC 分为一个执行委员会和三个工作组，共有 44 名成员 PRMC 根据 NIH 标准为每个方案分配 1-9 的科学评分。 此外，还会为援助协议分配高、中或低的 DLDCC 优先级分数。 已获得 NCI 癌症治疗评估计划 (CTEP) 批准的研究或 癌症预防和控制方案审查委员会或由 NIH 资助的 需要全面同行审查作为供资流程一部分的机制需要经过快速行政审查 审查。 PRMC 还在每个开放协议的年度报告中监控活跃研究的进展和累积情况。 IRB 审查，或者如果认为有必要，PRMC 会更频繁地进行全面审查，以确保充分 此外，PRMC 正在审查每个开放协议的收益。 PRMC 按季度开展计划，与 IRB 互补但不重复。 PRMC 向临床研究领导层提供报告。 委员会，该委员会还接收数据安全监测委员会的报告，从而确保 这两项独立权利的活动是整合在一起的。 从 2011 年到 2013 年，PRMC 平均每年审查 44 份新提交的申请，其中 10 份 研究者发起机构、19 个国家集团、3 个其他外部同行评审以及 12 个行业 每年还平均对正在进行的进展进行 140 次年度审查。