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PROTOCOL REVIEW AND MONITORING SYSTEM

方案审查和监测系统

基本信息

批准号：
7944683
负责人：
LIONEL David LEWIS
金额：
$ 4.64万
依托单位：
DARTMOUTH COLLEGE
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-04-21 至 2013-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7944683
关键词：
Address Amendment Area Benefits and Risks Biometry Budgets Cancer Center Support Grant Cancer Patient Clinical Clinical Oncology Clinical Practice Guideline Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Clinical trial protocol document Committee Members Conflict of Interest Data Development Disease Disorder by Site Ensure Frequencies Funding Agency Informed Consent Left Letters Life Malignant Neoplasms Mediation Medical Monitor Norris Cotton Cancer Center Oncology Group Patients Persons Phase Physician Executives Preparation Principal Investigator Procedures Process Protocols documentation Publications Recruitment Activity Reporting Research Research Ethics Committees Research Personnel Resources Review Committee Rights Risk Safety Schedule System Voting Voting Right Writing anticancer research base cancer prevention college cooperative study data integrity design falls human subject human subject protection meetings member patient population programs tumor registry working group

项目摘要

Since January 1996, a scientific review committee (Clinical Cancer Research Committee¿CCRC) and a Safety and Data Monitoring Committee (SDMC) have functioned at Norris Cotton Cancer Center. The CCRC reviews each new clinical trial protocol prior to Institutional Review Board (IRB) review, and the SDMC monitors safety and data integrity on a regular basis throughout the trial. Prior to IRB review, the NCCC Office of Clinical Research (OCR) submits the protocol to the CCRC. The CCRC is responsible for the scientific review of all new studies involving cancer patients or cancer prevention in human subjects. This assessment involves a review of all scientific aspects of the study, including the required safety and data monitoring plan. Once a protocol receives CCRC and IRB approval, the protocol is considered open for activation.

自 1996 年 1 月以来，科学审查委员会（临床癌症研究委员会¿CCRC）和安全和数据监测委员会 (SDMC) 在 Norris Cotton 癌症中心运作。中国儿童研究中心在机构审查委员会 (IRB) 审查之前审查每个新的临床试验方案，并且 SDMC 在整个试验过程中定期监控安全性和数据完整性。在 IRB 审查之前，NCCC 临床研究办公室 (OCR) 将方案提交给 CCRC。 CCRC 负责对所有涉及癌症患者或人类受试者癌症预防的新研究进行科学审查。这评估涉及对研究的所有科学方面的审查，包括所需的安全性和数据监测计划。一旦协议获得 CCRC 和 IRB 批准，该协议就被视为开放激活。