Structure,Function and Operation Practice of Clinical Trial Management System in Our Hospital
10.6039/j.issn.1001-0408.2015.34.03
- VernacularTitle:我院药物临床试验管理系统的构架、功能及运行实践Δ
- Author:
Jia ZHAO
;
Chunmei JIANG
;
Mingming LI
;
Yuan GUO
;
Wen WEN
;
Lijie LANG
;
Guoxin LI
- Publication Type:Journal Article
- Keywords:
Clinical trial management system;
Structure;
Function;
Operation effect
- From:
China Pharmacy
2015;(34):4759-4761,4762
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To promote the supervision and management of clinical trial by institution. METHODS:The structure and function of clinical trial management system(CTMS)developed by our hospital and other enterprise together were analyzed to evaluate the application and operation result of CTMS. RESULTS & CONCLUSIONS:CTMS of our hospital is made up of foun-dation,efficiency and strategy. It is equipped with role allocation,information exchange and report,information warning,drug tracking,clinical trial process control,quality control of electronic record,electronic signature and integration and connection with other system,etc. Relevant operation procedure is established to promote standardization and institutionalization of CTMS. Due to the application of CTMS,the cooperation among departments become smoother,and management level have been enhanced in dai-ly management,pharmacy management,subjects and document administration. It also simplifies the work of researcher and reduc-es the human error by the autogeneration of trial records and tables with the system. Consequently,the monitor coveraged through-out all the trial process.
