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。 The case report form (CRF) is the main document for clinical trial data collection. The well-designed CRF contributes to the construction of the database, improves the accuracy of the collected data, reduces the data doubts and makes it easy for researchers to fill in and make statistical analysis easy. CRF design process should be standardized, data collection must meet the requirements of the test program. The design of the CRF page layout should be clear, field design and coding should be standardized.