Discussion of the site visit strategy of Institutional Review Board
10.3760/cma.j.issn.1006-1924.2019.04.002
- VernacularTitle:伦理委员会实地访查策略的探讨
- Author:
Hongwu LIAO
1
;
Chunyi HAO
;
Lei ZHANG
;
Ting LU
;
Shunlian ZHOU
;
Jie LI
Author Information
1. 北京大学肿瘤医院暨北京市肿瘤防治研究所医学伦理委员会 恶性肿瘤发病机制及转化研究教育部重点实验室 100142
- Keywords:
Institutional Review Board/Ethics Committee;
Continual review;
Site visits;
Review strategy;
Clini-cal trial supervision
- From:
Chinese Journal of Medical Science Research Management
2019;32(4):246-249
- CountryChina
- Language:Chinese
-
Abstract:
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 de-tailed normative description of site visit in ethical guidelines and relevant articles ,as well as the varying degrees of implementa-tion 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 time-ly 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 .
