Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10411213
• 负责人: Shivaani Kummar
• 金额: $ 20.13万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10411213
• 关键词: Biometry; Cancer Patient; Clinical Research; Clinical Trials; Clinical trial protocol document; Data; Development; Disease; Doctor of Medicine; Enrollment; Ensure; Evaluation; Goals; Guidelines; Human Resources; Institutes; Institutional Review Boards; Malignant Neoplasms; Monitor; Peer Review; Pharmacology; Population; Process; Protocols documentation; Research; Resources; Safety; Site; Specific qualifier value; Support System; System; Time; Translational Research; authority; design; falls; patient population; sound

PROJECT SUMMARY: Protocol Review and Monitoring System Shivaani Kummar, M.D., Associate Director of Clinical and Translational Research The Knight Cancer Institute (KCI) Protocol Review and Monitoring System (PRMS) supports the development of a comprehensive and scientifically relevant portfolio of clinical trials. The PRMS ensures that cancer patients have access to clinical trials that are scientifically sound in design, feasible for timely completion, compliant with federal guidelines, deserving of priority, and in alignment with the strategic goals of the institute. There are two distinct stages of scientific review for all clinical trials. The first stage comprises the Clinical Research Disease Site Group (DSG), and the second stage is the KCI PRMS Committee. Proposed trials undergo an initial review by the DSG to assess scientific merit, alignment with the KCI and disease site goals, available resources including relevant patient population, feasibility for completion within the specified timeframe, competing trials, and fit within a disease-level portfolio. In the second stage of the process, the PRMS reviews for the relevance of the scientific question, soundness of the design, feasibility to conduct the trial, and ability of the trial to meet an unmet need within the disease trial portfolio. Eligible protocols undergo a formal scientific progress evaluation twice yearly to monitor accrual against the target with appropriate corrective actions for protocols that fail to meet accrual targets. In addition, scientific relevance is re-evaluated for trials open to accrual beyond five years. The PRMS has full authority to enact the scientific progress evaluation determination. Personnel in the KCI Clinical Research Quality and Administration group provide administrative support for the PRMS Committee, which acts independently of the OHSU Institutional Review Board (IRB) and the KCI Data and Safety Monitoring Committee (DSMC).

项目总结：协议审查和监测系统 Shivaani Kummar，医学博士，临床和翻译研究副主任 奈特癌症研究所(KCI)方案审查和监测系统(PRMS)支持开发 一个全面的和科学相关的临床试验组合。PRMS确保癌症患者 能够获得设计科学合理、可及时完成、符合 联邦指导方针，值得优先考虑，并与研究所的战略目标保持一致。有两个 对所有临床试验进行不同阶段的科学审查。第一阶段包括临床研究疾病 网站小组(DSG)，第二阶段是KCI PRMS委员会。拟议的试验将经过初步审查 由DSG评估科学价值、与KCI和疾病地点目标的一致性、可用资源 包括相关患者群体、在规定时间内完成的可行性、竞争性试验、 并符合疾病级别的投资组合。在流程的第二阶段，PRMS审查相关性 科学问题，设计的合理性，进行试验的可行性，以及试验满足的能力 疾病试验组合中未得到满足的需求。符合条件的议定书将接受正式的科学进展评估 每年两次，根据目标监控应计金额，并针对不符合要求的协议采取适当的纠正措施 应计目标。此外，对于五年以上可应计的试验，重新评估科学相关性。这个 PRMS完全有权制定科学进展评估决定。KCI诊所的工作人员 研究质量和行政小组为PRMS委员会提供行政支持，该委员会负责 独立于OHSU机构审查委员会(IRB)和KCI数据和安全监测委员会 (Dsmc)。