伦理委员会实地访查策略的探讨

Discussion of the site visit strategy of Institutional Review Board

目的探讨伦理委员会实地访查的适合策略,以切实、有效地落实对临床研究的监管,规范临床研究的实施。方法鉴于目前的伦理指南对实地访查缺乏详尽的规范性描述,相关文章探讨较少,各伦理委员会开展情况及深入程度不一,本文作者通过对多次参加实地访查的案例进行分析,从实地访查的程序、内容及注意事项展开论述。结果实地访查是对临床研究实施情况进行全面、深入、真实了解的重要环节,有利于帮助申办方/研究者提升意识,加强对GCP的遵循性,并对实施过程中出现的问题及时纠正,充分保障了后续研究的规范实施,切实落实受试者权益及安全。结论伦理委员会规范、高效的实地访查策略是临床试验实施过程中重要的监管策略之一,是对常规伦理材料审查的有效补充。

Objective To discuss appropriate strategies of site visits in ethical committees, to enhance the supervision of clinical trials effectively, and standardize the implementation of clinical research. Methods In consideration of the lack of detailed normative description of site visit in ethical guidelines and relevant articles, as well as the varying degrees of implementation and understanding of site visits among different ethical committees. This article discussed the procedures, contents and considerations of site visit based on the analysis of numerous site visits cases conducted. Results Site visit is one of the crucial procedures to more comprehensive, in-depth and truly understanding of the implementation of clinical trials. It is helpful to help sponsors/investigators enhance awareness and compliance with the good clinical practice. It also helps to correct problems timely during the implementation process to assure the standardized implementation of follow-up studies, and finally, effectively protect the rights and interests and safety of subjects. Conclusions Standardized and efficient site visit strategy of the ethical committee is one of the important regulatory strategies in the implementation of clinical trials and is an effective supplement to the regular review of ethical materials.