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Data capture tools: case report form (CRF) 

Data capture tools: case report form (CRF)
Chapter:
Data capture tools: case report form (CRF)
DOI:
10.1093/med/9780199608478.003.0016
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date: 24 May 2018

This chapter outlines the overall design process, highlights the aspects of design that are significant for the success of the case report form (CRF) and considers the effects of electronic data capture (EDC) in the production of electronic CRFs (eCRFs). It defines the purpose and regulatory requirements in designing a CRF. The chapter describes the data to be recorded in the CRF to answer the hypothesis being posed and collect safety data. The layout and design features are reviewed ensuring an aesthetically pleasing, easy to complete format is achieved. Hint and tips for CRF completion are described and the chapter shows how important question construction is in achieving the objectives of a CRF. The process of CRF printing is described and the different methods for binding and their importance in the production of a robust CRF. The pros and cons of Paper vs. eCRFs is described and the use of tablets and mobile phones being used for data capture is explored, Whatever the method of data capture the design features of the CFR will largely remain the same.

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