Collecting Data The Case Report Form

Derenzo and Moss (2006) provided a detailed discussion of clinical research protocols, and readers are directed to their book. 

Case report forms (CRFs) are used throughout clinical trials to record data collected during a trial. They record all of the information specified in the protocol for each subject (all data recorded on the CRF must be verifiable from original source documentation). While the traditional paper CRF format is still used, electronic data collection is becoming more common. Voorhees and Scheipeter (2005) discussed CRF development in detail, highlighting some of the fundamental aspects of their purpose, design, and nature  

Prokscha (2007) commented that a cross-functional team is needed to design a CRF that is clear and easily completed by the investigators, is efficient for data management processes, facilitates statistical analysis appropriately, and can therefore provide data that can allow decisions to be made concerning the safety and efficacy of the drug. 

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