eCRF (electronic case report form)
Glossaries
| Term | Definition |
|---|---|
| eCRF (electronic case report form) |
An auditable electronic record of information that is reported to the sponsor (or sponsor's agent such as an EDC provider) on each trial subject to enable data pertaining to a clinical investigation protocol to be systematically captured, reviewed, managed, stored, analyzed, and reported. The eCRF is a CRF in which related data items and their associated comments, notes, and signatures are linked programmatically. See also case report form, CRF, eSRF.[CSUICI; Revised from FDA Final Guidance on eSource]
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