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Fig. 1 | BMC Medical Research Methodology

Fig. 1

From: Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial

Fig. 1

Summary of the study design. A nutritional assessment study served as use case to test our hypotheses regarding data collection methods in clinical trials. In this study, patient information was collected in two ways. Patients either entered information themselves into standardized instruments such as questionnaires or information about the patient was obtained by a study nurse and then entered. Entering patient information could be done in two ways that included either direct access to the digital database through an electronic case report form (eCRF) or indirect access by filling a paper based case report form (pCRF) that was subsequently transferred to the database (pCRF to eCRF). Precise records were taken for times required for data entry by either CRF type, subject type performing data entry and instrument type being used

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