case report form (CRF)
Glossaries
| Term | Definition |
|---|---|
| case report form (CRF) |
A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each trial subject. NOTE: In common usage, CRF can refer to either a CRF page, which denotes a group of one or more data items, linked together for collection and display, or a casebook, which includes the entire group of CRF pages on which a set of clinical study observations can be or have been collected by completion of such CRF pages for a subject in a clinical study. See also CRF (paper), eCRF. [ICH E6 Glossary, FDA Final Guidance on eSource].
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Synonyms:
case record form |
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