Establishment and Application of Electronic Data Capture System in Drug Clinical Trials of Our Hospital
10.6039/j.issn.1001-0408.2016.04.06
- VernacularTitle:我院药物临床试验电子数据采集系统的建立及应用
- Author:
Jia ZHAO
;
Chunmei JIANG
;
Yuan GUO
;
Mingming LI
;
Wen WEN
;
Lijie LANG
;
Guoxin LI
- Publication Type:Journal Article
- Keywords:
Drug clinical trials;
Electronic data capture;
Quality control system;
Function;
Application
- From:
China Pharmacy
2016;(4):452-454
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To ensure the stability of electronic data capture(EDC)system in drug clinical trials and to improve the quality of drug clinical trials. METHODS:The quality control system for EDC system was established and introduced from the formulation of quality control process,establishment of data standard,trial project management,daily management,trial project design,system operation,system function,etc. RESULTS & CONCLUSIONS:Data standard have been achieved through estab-lishing EDC quality control system by our hospital based on attributable,legible,contemporaneous,original and accurate principle. The management of trial project and daily management are conducted through data registration,staff training,the formulation of da-ta management plan,fault emergency treatment,database backup;multiple verification of support data,data lock and export,trial report autogeneration and other functions have been realized by formulating related standard operation instruction,program file,op-eration manual and quality record. Those aspects improve facticity,accuracy and integrality of data in clinical trials,and lay a foun-dation for further data mining.
