Construction and implementation of a centralized monitoring scheme for investigator initiated trials
10.3760/cma.j.cn111325-20240408-00254
- VernacularTitle:研究者发起的临床研究中心化监查方案的构建与实施
- Author:
Wenwen LYU
1
;
Lei DUAN
;
Ying QIAN
;
Xuxu YANG
;
Jiayuan JIANG
;
Jiali JIAO
;
Weiyu LIU
;
Tingting HU
;
Zhongxun DONG
;
Biyun QIAN
Author Information
1. 上海交通大学医学院临床研究中心，上海 200025
- Publication Type:Journal Article
- Keywords:
Clinical research;
Centralized monitoring;
Key processes;
Key data;
Risk response measures
- From:
Chinese Journal of Hospital Administration
2024;40(12):964-968
- CountryChina
- Language:Chinese
-
Abstract:
Centralized monitoring is a risk-based remote monitoring mode that can effectively improve monitoring efficiency and quality. From July to September 2023, this study developed a centralized monitoring scheme for investigator initiated trials(IIT). This scheme utilized electronic data collection system and clinical research document management system, using programming techniques to compare the consistency of key project processes and data, monitor data filling, distribution trends, logical relationships, as well as documents such as informed consent forms, protocol violation records, and adverse event reports. It could timely identify problems in clinical trials and develop targeted response measures. From October to December 2023, 6 experts conducted centralized monitoring for 153 IIT projects using this scheme and found common issues in program execution(86 projects), ethical approvals(68 projects), and informed consent forms(67 projects), and so on. At the scome time, corresponding measures were developed. The process took a total of 20 days, with an average time of 6.27 hours per project. Compared with traditional on-site monitoring, the centralized monitoring scheme developed in this study had shown certain advantages in terms of timeliness, which could help guide the efficient implementation of on-site monitoring work and provide references for tertiary public hospitals to improve the quality of clinical trials.
