从病例报告表看金桥工程四种数据采集模式

Analysis of Four Data Capture Models using Case Report Forms in Golden Bridge

"金桥工程"(golden bridge,GB)这一临床试验项目得以顺利运行的关键元素之一就是病例报告表(ca.se report form,CRF),目前存在纸质版、手机版、网络版、电子病历版4种模式,该工程实行的是以电子版为主的多种CRF模式相结合的方式。这4种模式在数据报告、后期处理环节及质量监控3个方面都有各自的特点。电子病例报告表(electronic clinical report form,E-CRF)在数据产出各个环节较纸质版更有优势,确保了数据采集的质量和效率,具备开放性、可扩展性、安全性、稳定性、易维护性及易用性等特点,其中又以E-CRF最具发展潜力模式。总之,从不同模式的CRF特点比较来看,E-CRF是实现数据质量提升和保证的一个重要进步,而且E-CRF是提高数据管理质量最重要、最有意义的一个目标和方向,对确保临床试验研究的质量与科学性,提高整个医疗系统管理质量及服务质量,有着重要意义,但尚需要一个实践的过程及相关课题设计完成对各种数据采集方式价值的比较。

A case report form（CRF） is one of the key elements of Golden Bridge（GB）-a huge nationwide clinical trial. Four mainly types of CRY are paper-based records;smart phones; PC-based records through internet; electronic case report combined with CRF. GB mainly uses electronic data capture（EDC） ways along with the traditional methods. The four types of CRF mean four data capture models. They have their own characters through the whole data-producing procedure, including data acquisition, data report and data quality control respectively. The EDC has more merits than the paper-based one, such as expandability, security, system-stability maintainability, handleability, etc. The electronic case report is the most promising one to be best to guarantee the accuracy of clinical trials data and be the most economical way. Their real practical values in the clinical trial still need to be test by study in the long run.