病例报告表设计的要点

Key factors in design of case report form

病例报告表(CRF)是临床试验收集数据的主要文件,设计良好的CRF有助于数据库的构建,提高收集数据的准确性,减少数据质疑,方便研究者填写且易于统计分析。CRF设计流程应当规范,数据采集须符合试验方案要求。设计的CRF页面应布局清晰,字段设计及编码应规范。

Case report form （CRF） is a key document for data collection in clinical trials. A well-designed CRF is required for database construction, data accuracy, data query/cleaning, CRF completion andstatistical analysis. A well-defined process or SOP should be in place for CRF design. Data collection shouldfully meet the demand of study protocol. The layout of CRF should be clear with well-structured fields andstandard coding for fields.