临床试验伦理委员会对临床研究中不依从/违背或偏离方案报告的管理

Ethics Committee's Management of Noncompliance/Violation or Protocol Deviation Report in Clinical Research

随着我国一系列临床试验相关法规和指南的出台,对临床研究过程的规范管理要求逐步明确,也对伦理委员会的跟踪审查管理提出了更高要求。通过对某医院近两年受理的128份不依从/违背或偏离方案报告进行归纳和总结,对管理层面存在的研究者漏报告或报告不及时;研究者报告填写不规范;同类型的违背/偏离方案事件重复发生;对伦理委员会审查意见整改不力共四个主要问题进行分析,并提出相应的处理建议,以期加强和完善对不依从/违背或偏离方案报告的规范管理。

With the promulgation of a series of laws and regulations in our country,the requirement for standardized management of clinical research process are gradually clear,and higher requirements on the following-up review management of ethics committee also are put forward. Through concluding and summarizing 128 noncompliance/violation or protocol deviation reports accepted by a hospital in recent two years,this paper analyzed four main problems including that the researchers at management level failed to report or report timely; the researchers reported in irregular filling; the same type of violation/deviation program happened repeatedly and the rectification to the review opinions of ethics committee was ineffective,and also put forward the corresponding suggestions,in order to strengthen and perfect the standard management of noncompliance/violation or protocol deviation report.