Ethics Committee' s Management of Noncompliance/Violation or Protocol Deviation Report in Clinical Research
10.12026/j.issn.1001-8565.2018.03.13
- VernacularTitle: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
- Author:
Cuiyun WU
1
;
Guoying CAO
;
Rong WU
;
Hejian ZOU
Author Information
1. 复旦大学附属华山医院伦理审查委员会
- Keywords:
Clinical Research;
Protocol Noncompliance/Violation;
Protocol Deviation;
Ethics Committee
- From:
Chinese Medical Ethics
2018;31(3):328-331
- CountryChina
- Language:Chinese
-
Abstract:
With the promulgation of a series of laws and regulations in our country, the requirement for stand-ardized 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 noncompli-ance/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.
