CORE--CLINICAL TRIAL PROTOCOL REVIEW/MONITORING SYSTEM

核心——临床试验方案审查/监测系统

• 批准号: 6592164
• 负责人: CARLOS J CARRERA
• 金额: $ 18.37万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-02-01 至 2002-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6592164
• 关键词: biomedical facility; clinical trials; experimental designs; health care service evaluation; health services research tag; human data; neoplasm /cancer; neoplasm /cancer therapy

Description: This required system for cancer centers has a committee composed of ten members and the unit is headed by Carlos Carrera, M.D. The committee has statistical and primarily clinical representation, with ad hoc additional basic scientist reviewers. There are 4 aims which include providing peer review of all cancer-related clinical protocols; review of protocol progress; authorization of continuation or discontinuation of protocols and prioritize protocols by discipline through the Specialized Cancer Units. From May 1999 through February 2000, the PRMS reviewed 87 protocols, 58 NCI, 16 institutional, and 13 from pharmaceutical companies. The PRMS has 4 categories of decisions: Approval, Approved Pending IND, Approved Pending Clarification, and Deferred. Monitoring is provided for informed consent (Level 1), for accrual (Level 2), and for in-depth monitoring (Level 3). The Chair, Dr Carlos Carrera, continues in his role from the prior submission.

描述：癌症中心所需的系统有一个委员会 该小组由 10 名成员组成，由医学博士 Carlos Carrera 领导。 委员会具有统计和主要临床代表性，并有特别 其他基础科学家审稿人。有 4 个目标，其中包括提供 所有癌症相关临床方案的同行评审；审查方案 进步;继续或终止协议的授权以及 通过专业癌症单位按学科确定方案的优先顺序。从 1999 年 5 月至 2000 年 2 月，PRMS 审查了 87 项方案、58 项 NCI、16 项 机构，13 个来自制药公司。 PRMS 有 4 决策类别：批准、批准待定 IND、批准待定 澄清，并推迟。提供监测以获得知情同意 （级别 1）、应计（级别 2）和深入监控（级别 3）。这 主席 Carlos Carrera 博士继续担任之前提交的文件的职务。