目的：保证药物临床试验电子数据采集（EDC）系统稳定运行，提高药物临床试验质量。方法：从质量管理流程的制订、数

据标准化的建立、试验项目管理、日常管理、试验项目设计、系统操作、系统功能等方面介绍我院EDC系统的质量管理体系。结果

与结论：我院建立的EDC质量管理体系以数据质量的可归因性、易读性、同时性、原始性和准确性为原则，实现了数据标准化。通

过资料备案、人员培训、制订数据管理计划、故障应急处理和数据库备份进行试验项目的管理和日常管理，制订了相关的标准操作

规程、程序文件、操作手册或质量记录，实现了支持数据的多重验证核查、数据锁定与导出、自动生成试验报告等功能，可提高临床

试验过程中产生数据的真实性、准确性和完整性，为进一步数据挖掘工作奠定了基础。

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 establishing

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 data

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，operation

manual and quality record. Those aspects improve facticity，accuracy and integrality of data in clinical trials，and lay a foundation

for further data mining.