Preferred Label : Electronic Source Data;
NCIt related terms : eSource data;
NCIt definition : Digital information in original records, and certified copies of digital information
in original records.;
Alternative definition : CDISC-GLOSS: Source data captured initially into a permanent electronic record (eSource
document) used for the reconstruction and evaluation of a clinical study or a source
data item included in an eCRF when direct entry is made. NOTE: permanent in the context
of these definitions implies that any changes made to the electronic data are recorded
via an audit trail. See also eSource document, source data, permanent data, data originator.
[From body of FDA Final Guidance on eSource];
NCI Metathesaurus CUI : CL540500;
Origin ID : C142534;
UMLS CUI : C4684656;
Semantic type(s)
- concept_is_in_subset
