Study Documentation: What is a Case Report Form (CRF)?

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3. What is a Case Report Form (CRF)?

The ICH-GCP Guideline glossary defines a ‘case report form’ (CRF) as:

‘A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial participant's.'

This is an example of a CRF in which information like the weight of a patient, their body temperature, breathing frequency, blood pressure, and pulse frequency are captured.