从临床研究数据管理角度设计病例报告表

CRF development from the standpoint of clinical data management

病例报告表(CRF)是临床研究数据获取的主要工具,其重要性仅次于方案。书面与电子CRF对于数据收集与数据管理的效率与数据质量有不同的影响。CRF设计属于临床研究数据管理(CDM)设计与计划阶段的一个程序步骤。因此,从CDM的角度出发,考虑CRF的设计要求、设计时点、流程与设计要点,不仅有助于获得正确、有效的数据,还能使数据管理的其他程序步骤的效率提高、错误发生率降低。

Case report form （CRF） has been used as an essential tool to capture data in the clinical studies, which is next to a par with the clinical protocol development. Utilization of paper and/or electronic CRF affects the efficiency of data collection and management as well as data quality. CRF development is a part of important processes in preparations and plans of Clinical Data Management （CDM）. From the standpoint of CDM, strategies of CRF development, such as requirements, timeline, flow chart and keynotes of the CRF design, are definitely a guarantee for the procurability of accurate and valid data, but also facilitate efficiency and quality of other CDM-related processes.