Preferred Label : Electronic Source Document;
NCIt related terms : eSource document;
NCIt definition : An original record containing digital data.;
Alternative definition : CDISC-GLOSS: Electronic record containing source data for a clinical trial, used to
aggregate a particular instance of eSource data items for capture, transmission, storage,
and/ or display, and serving as a source document for a clinical investigation. NOTE:
Electronic Source documents are recorded in electronic systems according to conventions
(such as those for PDF documents) that ensure that all the fields of eSource data
and associated contextual information (e.g. time of capture, time zone, authorship,
origin, signatures, revisions, etc.) are linked to each other in a particular structure
for presentation. The encoded specifications in the electronic record thus serve the
same role as have the physical properties of paper (binding data items together).
eSource documents are subject to regulations and guidance that apply to source documents.
See also source documents. [relevant to FDA Final Guidance on eSource];
NCI Metathesaurus CUI : CL540499;
Origin ID : C142535;
UMLS CUI : C4684657;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
