摘要
数据采集是影响临床研究质量的关键环节之一,通过电子数据采集软件系统(Electronic DataCapture System,EDC)实现数据采集具有节约时间和人力物力、提高效率、保证质量和可靠性等优势。国际临床数据交换标准协会(Clinical Data Interchange Standards Consortium,CDISC)建立了一系列临床研究数据标准,用于支持临床及临床前数据的电子获取、交换、递交和归档。在EDC系统中应用CDISC标准,能更好地保证临床研究数据有效、规范化的采集。本文以Oracle公司的Oracle临床数据管理软件(Oracle Clinical/Oracle RemoteData Capture,OC/RDC)系统为例,从直接应用、间接应用两方面具体介绍了如何在EDC系统实施CDISC标准。为了更好地在EDC系统中应用CDISC标准,我们建议从临床试验设计开始考虑数据采集问题,并且在病例报告表(Case Report Form,CRF)设计阶段应用CDISC标准。利用EDC系统结合CDISC标准设计电子CRF(electronic CRF,e CRF)需要耗费一定的时间与精力,而且如果设计考虑不周到,会造成数据采集错误。因此,建议在应用EDC系统时,设置一个专门人员进行e CRF设计与维护,同时,一个组织内建立一套基于CDISC标准的标准化e CRFs和标准操作规程。
Data acquisition is one of the key links that influencing the quality of clinical research. Electronic datacapture system（EDC） embodies the advantages of saving time, manpower and material resources and improvingefficiency and reliability by data acquisition. CDISC has established worldwide industry standards to support theelectronic acquisition, exchange, submission and archiving of clinical research data. The application of CDISC standardsto EDC system is favorable in ensuring the validity and standardization of clinical data. This paper takes the Oracle＇s OC/RDC（Oracle Clinical/Oracle Remote Data Capture） system as an example to discuss the application of CDISC standardto EDC system from the two aspects： direct application and indirect application. We suggest that data collection shouldbe taken into account during the design phase of a clinical trial, and the CDISC standard be applied at the CRF designstage. A design for e CRF takes time and effort by the combination of EDC system and CDISC standard, while thoughtlessdesign may collect the wrong data. Therefore, it is suggested that a specialized personnel should be put in charge of e CRFdesign and maintenance during the operation of EDC system, and a set of standardized e CRFs based on CDISC standardand standard operating procedures should be built in one organization.
出处
《世界科学技术-中医药现代化》
CSCD
2017年第2期332-338,共7页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
广东省中医院中医药科学技术研究专项课题(YN2015QN22):CDISC针灸治疗领域标准制定
负责人:李庚
广东省中医药局课题(20142060):CDISC标准在中医药临床试验数据管理中的应用研究
负责人:李晓彦
关键词
国际临床数据交换标准协会标准
电子数据采集软件系统
应用
设计
Clinical data interchange standards consortium standard
electronic data capture system
application
design
