CORE--CLINICAL TRIAL PROTOCOL REVIEW/MONITORING SYSTEM

描述：这个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，由卡洛斯·卡雷拉医学博士领导。 委员会有统计和主要的临床代表，有专门的 额外的基础科学家评审员。它有四个目标，包括提供 所有与癌症相关的临床方案的同行评审；方案的评审 进展；授权继续或中止议定书和 通过专门的癌症单位按学科排列方案的优先顺序。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家来自制药公司。PRMS有4个 决定类别：批准、批准待定IND、批准待定 澄清和延期。为知情同意提供监测 应计(1级)、应计(2级)和深入监测(3级)。这个 主席卡洛斯·卡雷拉博士继续发挥上一次提交的作用。

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.