Design and implementation of information management system for clinical research ethics review in large general hospitals

Abstract

Objective Discussing the approach to design and implementation of ethical review information management system in clinical research involving human subject. Methods Systematic design and implementation based on ICH-GCP, Chinese GCP, Ethical review of biomedical research involving human subjects, Standard Operating Procedure compliant with Asia Pacific SIDCER certification standards, as well as the working experiences of author group. Results According to the specific working procedures in Beijing e-plugger Support Technology Co. Ltd, We implement ethical management system with real-time online interactive work model among investigators, ethical committee secretariat and ethical reviewers, which is prepared for further system optimization and upgrade. Conclusions The application of ethical review information management system make the ethical management work more reliable, efficient, and also improve the quality of ethical review, which helps a lot in safeguarding the development of medical science. Key words: Clinical research; Ethical review; Management information system