Construction of data remote monitoring and auditing system for clinical trials.
10.3785/j.issn.1008-9292.2020.07.01
- Author:
Liang SHEN
1
;
Qian HUANG
2
;
You ZHAI
2
;
Yunqing QIU
2
;
Qingwei ZHAO
2
;
Lihua WU
2
;
Min ZHOU
1
;
Jian LIU
2
Author Information
1. Department of Information, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
2. Research Center for Clinical Pharmacy, Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
- Publication Type:Journal Article
- Keywords:
Clinical trial;
Clinical trial management system;
Remote auditing;
Remote monitoring
- From:
Journal of Zhejiang University. Medical sciences
2020;49(4):531-536
- CountryChina
- Language:Chinese
-
Abstract:
Clinical trial management system is independently developed by our hospital, which basically realized the whole process management and data collection of clinical trials. Based on the platform, the functional architecture of data remote monitoring and auditing was established. By desensitizing and encrypting of data, the project and subject hologram were visualized to facilitate to review of data. The data remote monitoring and auditing cloud platform adopts the B/S architecture pattern. Users register to apply for an account through the cloud platform, and access to the account via HTTPS security protocol. The authorized users were able to view the relevant items online to ensure the secure data transmission and easy operating. The electronic management of data is the direction of future efforts. By compliance with laws and regulations, the remote monitoring/auditing can be realized, and the data security and personal privacy can be ensured with the application of information technology. In this paper, the feasibility of remote monitoring/auditing mode is explored, specific technical schemes and system functions are suggested, and the realization scenarios are conceived in case of major public health emergencies.
