Protocol Review & Monitoring System (PRMS)

方案审查

• 批准号: 9792765
• 负责人: Sanjay Goel
• 金额: $ 7.16万
• 依托单位: ALBERT EINSTEIN 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/9792765
• 关键词: Albert Einstein Cancer Center; Cancer Center; Cancer Control; Cancer Therapy Evaluation Program; Clinical Research; Clinical Research Protocols; Collaborations; Data; Disease; Eligibility Determination; Ensure; Equipment; Funding; Funding Agency; Goals; Human Resources; Industry; Institutional Review Boards; Intervention; Left; Malignant Neoplasms; Manuals; Modality; Monitor; Peer Review; Pharmacologic Substance; Policies; Procedures; Process; Protocols documentation; Research Personnel; Review Committee; Safety; Specific qualifier value; System; Therapeutic; Time; Translational Research; United States National Institutes of Health; Update; Work; drug development; expedited review; experience; human subject protection; interest; investigator-initiated trial; meetings; member; multidisciplinary; patient population

PROJECT SUMMARY - PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring System (PRMS) provides scientific oversight of all clinical and translational research performed at the Albert Einstein Cancer Center (AECC). PRMS functions are carried out by the Protocol Review and Monitoring Committee (PRMC), a multidisciplinary group whose members have expertise and experience in therapeutics, drug development, and translational science. The PRMC performs a complete scientific, feasibility, and administrative review of all institutional investigator-initiated and industry- sponsored cancer-related protocols. The PRMC does not duplicate traditional peer review, which includes peer-reviewed protocols supported by the various NIH mechanisms, other approved funding agencies, and clinical research protocols supported by NCI's Cancer Therapy Evaluation Program or Cancer Control Protocol Review Committee. All NCI-sponsored protocols that have undergone prior peer review undergo an expedited administrative review for feasibility and overlapping eligibility with other trials. Functions of the PRMC are complementary to the Institutional Review Board (IRB), which focuses on the protection of human subjects, and separate from those of the AECC Data Safety Monitoring Committee (DSMC). The PRMC ensures that all trials have appropriate data safety and monitoring plans in place; data and safety monitoring functions are the responsibility of the DSMC. The system for initial review comprises 2-stages, starting first with approval by a disease or modality-oriented clinical research leader (CRL) and Associate Director for Clinical Research, followed by review by the PRMC. This 2-stage review process increases efficiency by (i) reducing staff effort in developing protocols and PRMC application materials of lesser scientific merit, (ii) reducing the time from concept approval to protocol activation, and (iii) decreasing the volume of protocols reviewed by the committee. Over the last 3-years (7/1/15-6/30/18), there were 442 new protocols activated, including 306 intervention (15% institutional) and 136 non-intervention (85% institutional).

项目摘要 - 协议审核和监视系统 协议审查和监控系统（PRMS）提供了所有临床和 在爱因斯坦癌症中心（AECC）进行的转化研究。 PRMS功能是执行的 由协议审查和监测委员会（PRMC），一个多学科小组，其成员拥有 治疗学，药物开发和转化科学方面的专业知识和经验。 PRMC执行 对所有机构研究者发动和行业的完整科学，可行性和行政审查 - 赞助癌症相关的方案。 PRMC不复制传统同行评审，其中包括 由NIH机制，其他批准的资金机构和 NCI的癌症治疗评估计划或癌症控制方案支持的临床研究方案 审查委员会。所有已接受过同行评审的NCI赞助的协议都会加快 行政审查，以便与其他试验重叠的资格重叠。 PRMC的功能是 重点介绍保护人类受试者的机构审查委员会（IRB）的补充， 并与AECC数据安全监测委员会（DSMC）分开。 PRMC确保所有人 试验具有适当的数据安全和监视计划；数据和安全监控功能是 DSMC的责任。初始审查的系统包括2个阶段，首先是由 疾病或以模态为导向的临床研究负责人（CRL）和临床研究副总监， 然后由PRMC进行审查。这个2阶段的审查过程通过（i）减少员工的努力来提高效率 开发较小科学功绩的协议和PRMC应用材料，（ii）从 协议激活的概念批准，以及（iii）减少由 委员会。在过去的3年（7/1/1/15-6/30/18）中，有442个新协议，包括306 干预（机构15％）和136个不干预（机构85％）。