Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10454178
• 负责人: Cardinale B Smith
• 金额: $ 26.04万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10454178
• 关键词: Biometry; Cancer Center Support Grant; Categories; Clinical Research; Data; Disease; Educational workshop; Ensure; Focus Groups; Goals; Guidelines; Health system; Institutes; Lead; Malignant Neoplasms; Mission; Monitor; Protocols documentation; Research; Safety; System; authority; design; medical schools; recruit

PROJECT SUMMARY/ABSTRACT The Protocol Review and Monitoring System (PRMS) of the Tisch Cancer Institute (TCI) oversees all cancer related clinical research conducted at the Mount Sinai Health System (MSHS). The major goal of the PRMS is to assure adequate internal oversight of the scientific aspects of cancer-related research by providing a rigorous initial scientific review and performing ongoing monitoring for scientific progress and accrual onto active cancer protocols. Protocol review is comprised of three components: Biostatistics Design Workshop, Disease Focus Groups, and the Protocol Review and Monitoring Committee (PRMC). Only the PRMC has the authority to open protocols that meet the scientific merit and priorities of the TCI and to terminate protocols that do not demonstrate scientific progress.

项目摘要/摘要 Tisch癌症研究所(TCI)的方案审查和监测系统(PRMS)监督所有癌症 在西奈山卫生系统(MSHS)进行的相关临床研究。PRMS的主要目标是 为了确保对癌症相关研究的科学方面进行充分的内部监督，提供 严格的初步科学审查，并对科学进展和收益进行持续监测 活跃的癌症治疗方案。方案审查由三个部分组成：生物统计学设计研讨会， 疾病重点小组和议定书审查和监测委员会(PRMC)。只有PRMC才有 有权开启符合TCI的科学价值和优先事项的议定书，并终止符合以下条件的议定书 不能展示科学的进步。