Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 9067942
• 负责人: GEORGE WILDING
• 金额: $ 16.81万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 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/9067942
• 关键词: Biometry; Cancer Center; Charge; Clinical; Clinical Data; Clinical Research; Clinical Trials; Comprehensive Cancer Center; Conflict of Interest; Data; Disease; Doctor of Medicine; Doctor of Philosophy; Faculty; Goals; Institutional Review Boards; Instruction; Leadership; Malignant Neoplasms; Medical Informatics; Medicine; Mission; Monitor; Oncology Group; Operating System; Performance; Policies; Positioning Attribute; Procedures; Protocol Compliance; Protocols documentation; Reporting; Research; Resource Allocation; Resources; Review Committee; Safety; System; Translational Research; Universities; Wisconsin; authority; data management; human subject protection; meetings; mid-career faculty; professor; research study; translational clinical trial; working group

PROJECT SUMMARY (See instructions): The University of Wisconsin Carbone Cancer Center (UWCCC) Protocol Review and Monitoring System (PRMS) operates via one main committee, the Protocol Review and Monitoring Committee (PRMC), which functions as the Scientific Review Committee for alt cancer-related research protocols. The PRMC is charged with the scientific and resource review of all new and ongoing clinical and translational research protocols. In addition, the PRMC reviews all cancer-related clinical and translational research for compliance with the UW-Madison Conflict of Interest policies and assures an appropriate Data and Safety and Monitoring Plan is included in each proposal. The PRMC accomplishes this via the following responsibilities; ¿ Review of all new clinical and translational trials for scientific merit, priorities and resource allocation ¿ Prioritization of new clinical and translational trials relative to the clinical Disease Oriented Working Groups (DOWG)/Clinical Research Groups (CRG) ¿ Prioritization of research relative to the scope of UWCCC ¿ Review of all ongoing clinical and translational trials for scientific progress ¿ Closing studies for insufficient progress or due to prioritization changes Through established procedures the PRMC is the oversight mechanism through which all UW-Madison cancer-related clinical and translational research must flow, thus assuring that all research conducted at UWCCC is of the highest scientific merit and that UWCCC resources are used efficiently. The PRMS is supervised by the Associate Director for Clinical Research. The PRMC reports to UWCCC Clinical Research Committee, and is chaired by Dan Mulkerin, M.D., Associate Professor of Medicine, and co-chaired by Menggang Yu, Ph.D., Assistant Professor of Biostatistics and Medical Informatics. Dr. Mulkerin has over 15 years of clinical research performance and monitoring. Dr. Yu served as the biostatistics and clinical data management director for the Hoosier Oncology Group for four years prior to joining the University of Wisconsin faculty in January 2012.

项目摘要（请参阅说明）： 威斯康星大学碳纤维癌中心（UWCCC）协议审查与监测系统（PRMS）通过一个主要委员会，协议审查和监测委员会（PRMC）运作，该委员会是与ALT癌症相关研究方案的科学审查委员会。 PRMC负责对所有新的和正在进行的临床和翻译研究方案的科学和资源审查。此外，PRMC还审查了所有与UW-Madison利益政策冲突的癌症相关临床和翻译研究，并假设每个提案中都包括适当的数据和安全性和监测计划。 PRMC通过以下职责来实现这一目标； »审查所有新的临床和翻译试验，以进行科学功绩，优先级和资源分配 �相对于面向临床疾病的工作组（DOWG）/临床研究组（CRG）的新临床和翻译试验的优先级 »研究相对于UWCCC范围的优先级 �审查所有正在进行的临床和翻译试验的科学进步试验 »结束研究不足或由于优先级的变化而导致的研究 通过既定的程序，PRMC是所有与UW-Madison癌症相关的临床和翻译研究必须流动的监督机制，从而确保在UWCCC进行的所有研究都是最高的科学功绩，并且UWCCC资源有效地使用了UWCCC资源。 PRM由临床研究副主任监督。 PRMC向UWCCC临床研究委员会报告，由医学副教授Dan Mulkerin主持，并由Menggang Yu博士合作，生物统计学和医学信息学助理教授。 Mulkerin博士拥有超过15年的临床研究表现和监测。 Yu博士在2012年1月加入威斯康星大学教职员工之前，曾担任Hoosier肿瘤学集团的生物统计学和临床​​数据管理总监四年。