EDC (electronic data capture)
Glossaries
| Term | Definition |
|---|---|
| EDC (electronic data capture) |
The process of collecting clinical trial data into a permanent electronic form. NOTE: Permanent in the context of these definitions implies that any changes made to the electronic data are recorded with an audit trail. EDC usually denotes manual entry of CRF data by transcription from source documents. The transcription is typically done by personnel at investigative sites. [After Guidance for Industry, Use of Electronic Health Record Data in Clinical Investigations, July 2018] See also data entry, direct data entry, data acquisition, data capture.
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