Protocol Review & Monitoring

方案审查

• 批准号: 7714440
• 负责人: ALEX A. ADJEI
• 金额: $ 7.6万
• 依托单位: ROSWELL PARK CANCER INSTITUTE CORP
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-28 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7714440
• 关键词: Amendment; Category Rating Scale; Charge; Clinical Research; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Development; Doctor of Philosophy; Ensure; Institutes; Leadership; Maintenance; Monitor; Outcome; Participant; Principal Investigator; Protocols documentation; Regulatory Affairs; Reporting; Research Design; Research Ethics Committees; Resources; Review Committee; Role; Roswell Park Cancer Institute; Supervision; System; Twin Multiple Birth; research study; response

Protocol Review and Monitoring at Roswell Park Cancer Institute (RPCI) is under the direct supervision of Dr Alex Adjei, Associate Director for Clinical Research. Components include the Scientific Review Committee (SRC), the Response Review Committee (RRC), the Clinical Research Management System (CRMS) and the new Clinical Research Feasibility and Prioritization Committee (CRFPC). The SRC provides oversight and assures the maintenance of high quality institutional clinical research. All research studies conducted at RPCI are reviewed by the SRC prior to submission to the IRB. The scope of the SRC responsibilities includes review and approval of new and ongoing clinical research studies, review and approval of study amendments and review and approval of the outcome of the analysis of non-accruing and slow accruing studies. The SRC reviews new studies to ensure that scientific content and study design are appropriate and that statistical oversight and collaboration is in place. The review of non-accruing and slow accruing studies occurs twice annually. The SRC provides a forum where the utilization of RPCI resources and the prioritization of clinical research studies are discussed. The Response Review Committee is charged with monitoring radiological response assessment and reporting the outcome of the review to the Scientific Review Committee and the Data and Safety Monitoring Board. Ellis Levine, MD, chairs the Response Review Committee and Alan Li twin, MD, provides the radiological review conducted by the Response Review Committee. Under the leadership and supervision of Dr Alex Adjei, Joyce Yasko, PhD oversees the function of the SRC including the development of prompt SRC communication of the outcome of the SRC review with the Principal Investigators and the review of slow or non accruing research studies. Julie Haney BS, CRS Director, Study Submission and Regulatory Affairs provides the administrative support for the role, responsibilities and outcomes of the SRC. Jennifer Cartonia provides critical secretarial support to the SRC.

罗斯威尔公园癌症研究所（RPCI）的方案审查和监测由 临床研究副总监Alex Adjei博士的监督。组件包括科学 审查委员会（SRC）、回复审查委员会（RRC）、临床研究管理层 新的临床研究可行性和优先级委员会（CRFPC）。的SRC 提供监督并确保维持高质量的机构临床研究。所有研究 在RPCI进行的研究在提交给IRB之前由SRC进行审查。SRC的范围 职责包括审查和批准新的和正在进行的临床研究，审查和 批准研究修正案，审查和批准非累积和 缓慢积累的研究。SRC审查新的研究，以确保科学内容和研究设计 适当的，统计监督和协作到位。审查非应计和缓慢 累积研究每年进行两次。SRC提供了一个论坛， 和临床研究的优先顺序进行了讨论。 反应审查委员会负责监测放射性反应评估， 向科学审查委员会和数据和安全性监查委员会报告审查结果 纸板. Ellis Levine医学博士担任响应审查委员会主席，Alan Li Twin医学博士提供 由反应审查委员会进行的放射性审查。 在Alex Adjei博士的领导和监督下，Joyce Yasko博士负责监督 SRC，包括制定SRC审查结果的及时沟通， 主要研究者和审查缓慢或非累积的研究。Julie Haney BS，CRS 研究提交和法规事务总监为该职位提供行政支持， SRC的职责和成果。Jennifer Cartonia提供重要的秘书支持， SRC.