Cases Analysis and Countermeasures Discussion on Ethical Review of Clinical Trial Protocol Violation
10.12026/j.issn.1001-8565.2022.04.12
- VernacularTitle:临床试验违背方案伦理审查的案例分析与对策探讨
- Author:
Xuan LUO
1
;
Yong ZHANG
1
;
Hongxin YANG
1
Author Information
1. Department of Pharmacy, Inner Mongolia People’s Hospital, Hohhot 010017, China
- Publication Type:Journal Article
- Keywords:
Clinical Trials;
Protocol Violation;
Ethical Review;
Ethics Committee
- From:
Chinese Medical Ethics
2024;35(4):421-426
- CountryChina
- Language:Chinese
-
Abstract:
To ensure the rights and safety of the subjects and improve the quality of clinical trials, the author analyzed and discussed the deviation type and typical cases from 184 cases of protocol violation reviewed by the ethics committee in 56 clinical trials in a tertiary hospital in 2020. Among the 184 cases of violating the protocol, there were 29 major protocol violation cases and its proportion is 16%; 99 cases (54%) violated the GCP principle; 56 cases of other violations of the protocol that require to be reported, accounting for 30%. Through the case analysis of the researcher gave the wrong doses to subjects without following the protocol and drug administration did not conform to the rules, analyzed and discussed from the five perspectives of the research protocol design, the researcher, the clinical trial institution, the sponsor and the ethics committee, and put forward solutions and suggestions, so as to provide reference to improve the compliance of clinical trial protocol, reduce the risk of subjects and protect their rights and safety and ensure the successful progress of clinical trials.
