Web-Based Case Report Form Design for Clinical Trial
With more clinical trials using electronic way, new drugs electronic application has becoming an inevitable trend in near future. A well-designed case report form (CRF) is the premise of high quality clinical trials which facilitates data collection and entry, and directly benefits other facets of clinical data management. Firstly, paper introduces the CRF design modes and design principles. Then paper describes the CRF design process, and based on this, paper constructs the data structure with CDISC ODM concept. Lastly, paper explores how to convert the paper CRF to electronic format in web application with SAS statistic requirements in detail.
L. L. Fu and T. Chen, "Web-Based Case Report Form Design for Clinical Trial", Applied Mechanics and Materials, Vol. 39, pp. 19-24, 2011