Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10627515
• 负责人: Ragini Reiney Kudchadkar
• 金额: $ 13.24万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-07 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10627515
• 关键词: Address; Amendment; Authorization documentation; Bioethics Consultants; Calendar; Cancer Center Support Grant; Catchment Area; Clinical; Clinical Research; Clinical Research Protocols; Clinical Trials; Collaborations; Committee Members; Committee Membership; Community Outreach; Complement; Consultations; Data; Disease; Enrollment; Ensure; Equilibrium; Equity; Ethics; Ethnic Origin; Feedback; Fostering; Frequencies; Gender; Goals; Grant; Guidelines; Institution; Institutional Review Boards; Leadership; Letters; Malignant Neoplasms; Modality; Monitor; Patients; Peer Review; Performance; Protocols documentation; Race; Research; Research Design; Research Proposals; Resources; Review Committee; Risk; Safety; Science; Scientific Evaluation; Services; Surveys; System; Training; Underrepresented Populations; Universities; Update; authority; cancer clinical trial; clinically relevant; community engagement; coronavirus disease; demographics; design; expedited review; improved; innovation; medical specialties; meetings; member; programs; sound; treatment trial; working group

PROJECT SUMMARY/ABSTRACT PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring System (PRMS) for Winship Cancer Institute of Emory University (Winship), is executed by the Protocol Review and Monitoring Committee (PRMC), which aligns clinical research with research programs and catchment area priorities, and oversees the scientific quality, merit, and feasibility of clinical trials. The PRMC is responsible for review, prioritization, and monitoring to ensure an innovative, impactful, and balanced clinical research portfolio that meets the needs of the Winship catchment area. The PRMC oversees the approval and termination of clinical trials based upon evaluation of scientific validity, feasibility, and accrual. The PRMC operates independently from the Winship Clinical Trials Office (CTO) and the DSMC. PRMC reviews are complementary and non-duplicative of IRB reviews. An initial scientific review is performed by the Winship Treatment Modality Working Groups (TMWG) that meet regularly to review trials and select studies for inclusion in their portfolios. In 2021, the PRMC reviewed 571 clinical trials; 40% were new protocols out of which 32% were expedited reviews and 40% institutional and externally- peer reviewed trials. The PRMC conducts quarterly scientific and accrual progress reviews for active trials. Enhancements to address new CCSG guidelines and further improve the efficacy of the PRMC since Winship’s last competitive grant renewal include: (1) risk level determination for all treatment trials; (2) prioritization of existing trials portfolio and establishment of review criterion of relevance to the catchment area; (3) annual surveys of Winship members to obtain feedback on PRMC functions and scientific utility; (4) PRMC membership update to balance representation of clinical specialties, race, ethnicity, and gender; and (5) enhanced training for TMWG members.

项目概要/摘要 方案审查和监测系统 埃默里大学温希普癌症研究所的方案审查和监测系统 (PRMS) (Winship)，由方案审查和监测委员会 (PRMC) 执行，该委员会负责协调临床 研究项目和流域优先事项，并监督科学质量、优点和 PRMC 负责审查、优先排序和监控，以确保临床试验的可行性。 创新、有影响力且平衡的临床研究组合，满足 Winship 流域的需求 PRMC 根据科学评估监督临床试验的批准和终止。 PRMC 独立于 Winship 临床试验办公室运作。 (CTO) 和 PRMC 审核与 IRB 审核是互补且不重复的。 科学审查由定期召开会议的 Winship 治疗方式工作组 (TMWG) 进行 审查试验并选择纳入其投资组合的研究 2021 年，PRMC 审查了 571 项临床试验。 试验；40% 是新方案，其中 32% 是快速审查，40% 是机构和外部试验 PRMC 每季度对正在进行的试验进行科学和权责发生制进展审查。 增强功能以​​适应新的 CCSG 指南并进一步提高 PRMC 的效率 Winship 的最后一次竞争性拨款更新包括：(1) 所有治疗试验的风险水平确定；(2) 现有试验组合的优先顺序并建立与流域相关的审查标准 (3) 对 Winship 成员进行年度调查，以获得有关 PRMC 功能和科学效用的反馈； PRMC 成员更新以平衡临床专业、种族、民族和性别的代表性； (5)加强对TMWG成员的培训。