Abstract: Case report form is designed to record drug efficacy and safety data in clinical trial. Whether or not the design of it is scientific and rigorous directly affects the success of a clinical trial. In this article, how to develop a CRF and the content of clinical data acquisition standards harmonization(CDASH) will be briefly introduced. Then, some modules of the CRF, which are often wrongly designed, and other common problems in designing the CRF will be analyzed and illustrated.

Key words: Case report form, Design, Clinical data acquisition standards harmonization, Module