Discussion of the site visit strategy of Institutional Review Board

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 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. Key words: Institutional Review Board/Ethics Committee; Continual review; Site visits; Review strategy; Clinical trial supervision