Design and practice of clinical trial management information system
10.12092/j.issn.1009-2501.2020.05.012
- VernacularTitle: 临床试验管理信息系统设计与实践
- Author:
Chan ZENG
1
Author Information
1. Research Center for Clinical Trial, the Third Xiangya Hospital, Central South University
- Publication Type:Journal Article
- Keywords:
Clinical trial;
Clinical trial management information system;
Information security
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2020;25(5):555-558
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To explore the information management of the whole process of clinical trials based on the laws and guidelines. METHODS: Taking the clinical trial management of our hospital as an example, we designed the clinical trial management information systems separately for researcher and sponsor to realize the whole process management of clinical trial in our hospital. RESULTS:The application of the clinical trial information management systems realized the real-time monitoring and information management of the whole process of project initiation, contract signing, ethical review, start-up, project selection/enrollment, subject management and conclusion. CONCLUSION: The separate design can ensure the information security of subjects, make effective statistics on the data generated, which can greatly improve the work efficiency of clinical trial management.
