Construction of informatization system of drug clinical trials ethical review based on cloud architecture
10.12092/j.issn.1009-2501.2021.09.007
- Author:
Zhihua SHE
1
;
Songyue LIANG
1
;
Zhou CHEN
2
Author Information
1. Hunan Provincial Maternal and Child Health Care Hospital
2. Changsha Tonoinfo Technlogy Co.,Ltd.
- Publication Type:Journal Article
- Keywords:
Clinical trials;
Cloud architecture;
Ethical review;
Informationize
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2021;26(9):1023-1030
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To improve the quality, efficiency, standardization and prospective management of ethical review of drug clinical trials in our hospital through the information system construction of ethical review of drug clinical trials. METHODS: The entire information system was designed based on the cloud architecture, enabling all ethics review applicants and ethics committees to use the same system for online registration and online business, which provided an information solution for the business model of regional ethics committees and multi-center ethics mutual recognition. RESULTS: Through the construction of ethical review platform of cloud architecture, the paperless and electronic management of ethical data have been realized, and online meeting review, tracking review and remote video conference have been realized on mobile and computer terminals. CONCLUSION: The information construction of ethical review system improves the efficiency and management level of ethical review in drug clinical trials.
