Case report form (CRF)

    In Documents & records

    A case report form is the structured record in which the data a protocol requires is reported to the sponsor for each participant. It is designed around the protocol, so each field maps to something the study needs to measure. Today almost all trials use an electronic version.

    Why it matters

    Only what reaches the CRF becomes trial data. Anything recorded in the notes but never transcribed to the CRF is invisible to the analysis.

    Example

    The protocol asks for blood pressure at every visit, so the CRF has a dated blood-pressure field for each visit \u2014 and the site copies the reading from the clinic notes into it.

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