按照临床试验方案的要求，设计一个简明实用的病例报告表(CRF)至关重要。临床试验资料收集的完整准确与否、临床试验质量的好坏均与CRF设计的科学性和合理性密切相关。CRF设计的原则和每一环节都要充分考虑其在使用过程中和完成后的统计分析需要，这需整个研究团队不同人员的配合和努力才能完成。同时，也应参考国际上相关规范或指南的要求，以利于与国际临床研究规范接轨。

In clinical trials，it is essential to design a simple and practical case report form(CRF) in accordance with the requirements of the protocol. Complete and accurate test data，and the quality of clinical trials depend on the scientific and reasonable design of CRF. CRF design is not simple. Every detail of its later use and the whole procedures of statistical analysis should be taken into account during the design of CRF. Therefore，the design of CRF was the team work，which needs the cooperation and efforts of each member of the study group. During the design of CRF，the international related standard or guideline should also be considered.

R285.6

国家重大新药创制专项课题(2012ZX09303009)；广东省科学技术厅-广东省中医药科学院联合科研专项(2011B032200011)。