CORE--CLINICAL TRIAL PROTOCOL REVIEW/MONITORING SYSTEM

描述：癌症中心所需的系统有一个委员会 由10名成员组成，由医学博士卡洛斯卡雷拉领导。的 委员会有统计和主要是临床代表，特设 更多的基础科学家评审员。有四个目标，包括提供 所有癌症相关临床方案的同行评审;方案评审 进展;授权继续或停止方案， 通过专门的癌症单位按学科优先处理方案。从 从1999年5月到2000年2月，PRMS审查了87项方案，58项NCI，16项 机构，13家来自制药公司。PRMS有4个 决策类别：批准、批准待决IND、批准待决IND 澄清和推迟。提供知情同意监测 （1级）、应计（2级）和深入监测（3级）。的 主席卡洛斯卡雷拉博士继续担任先前提交的职务。

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.