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.

Roswell Park癌症研究所（RPCI）的协议审查和监测直接 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），回应审查委员会（RRC），临床研究管理 系统（CRM）和新的临床研究可行性和优先委员会（CRFPC）。 SRC 提供监督并确保维持高质量的机构临床研究。所有研究 在提交给IRB之前，SRC对在RPCI进行的研究进行了审查。 SRC的范围 责任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，并审查和批准非批判性分析的结果 缓慢的计算研究。 SRC综述了新的研究，以确保科学内容和研究设计是 适当，统计监督和协作就位。对非练习和缓慢的审查 每年进行两次应计研究。 SRC提供了一个论坛，其中RPCI资源的利用 并讨论了临床研究的优先级。 响应审查委员会负责监视放射学响应评估和 将审查结果报告给科学审查委员会以及数据和安全监控 木板。埃利斯·莱文（Ellis Levine） 响应审查委员会进行的放射学审查。 在Alex Adjei博士的领导和监督下，乔伊斯·Yasko博士监督了 SRC包括SRC评论结果的及时SRC沟通的开发 首席研究人员以及慢速或非应计研究研究的综述。朱莉·汉尼（Julie Haney BS），CRS 研究提交和监管事务主任为该角色提供了行政支持， SRC的职责和结果。詹妮弗·卡托尼亚（Jennifer Cartonia）为 src。