Data Management CRF Design

A Case Report Form (or CRF) is a document or electronic questionnaire used specifically in clinical trial research. CRFs are used by the sponsor of a clinical trial to obtain and record data from each participating volunteer, including any adverse events that may occur.

The data collated in a CRF is used to test the study hypotheses or answer any questions relevant to the research study. CRFs can range from simple hand-written ‘snapshot’ of a patient’s physical condition to hundreds of pages of electronically captured data obtained over a period of weeks or months.

CRFs contain data obtained during the volunteer’s participation in a clinical study. Before this data is sent to the ‘sponsor’, it is usually de-identified (i.e. altered so that it is not traceable to the volunteer) by assigning the volunteer to a unique study number.

From the sponsor’s perspective; the main aim of conducting a clinical trial is to obtain accurate CRFs; however because of human and machine error, the data entered in CRFs is subject to discrepancies and thus need to be thoroughly cross-checked for any inconsistencies. Any discrepancies are noted as queries by the study administrators or automated mechanisms that process the CRFs.

To ensure quality control, these queries are addressed and resolved before the CRF data is included in the final clinical study report.

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