NCIt related terms : EDC (electronic data capture);
NCIt definition : The use of a computerized system to collect clinical trial data.;
Alternative definition : CDISC-GLOSS: 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.;