The role of information management system in the management of investigator initiated trials ethics re-view
10.3969/j.issn.1671-332X.2025.08.025
- VernacularTitle:信息化管理系统在研究者发起的临床研究伦理审查管理中的应用与思考
- Author:
Xiuxiu LI
1
;
Shaoying CHEN
Author Information
1. 宁波大学附属妇女儿童医院 浙江 宁波 315012
- Publication Type:Journal Article
- Keywords:
Ethical review;
Informatization;
Investigator initiated trials
- From:
Modern Hospital
2025;25(8):1239-1241,1245
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore how to enhance the quality and efficiency of ethics committee operations based on an information management system.Methods This study analyzes the challenges in the ethical review of Investigator Initiated Trials(IIT)and compares existing ethics review systems in China.Using a tertiary hospital as an example,the paper details the practi-cal impact of an information management system for improving the management level of the ethics committee office and the effi-ciency of project reviews.Results The ethics review information management system evolved from basic usage and initial ethics review functions to include ethics tracking review and meeting review capabilities,offering comprehensive functionality.Conclu-sion The information management system enhances the efficiency of ethical review processes,but ongoing optimization is neces-sary to better align with the needs of clinical research in medical institutions.