Preferred Label : Data Originator;
NCIt definition : The creating entity for each information element that identifies the source of the
information capture in the electronic case report form for a clinical investigation.
The source could be a person, computer system, device or instrument. (FDA);
Alternative definition : CDISC-GLOSS: Metadata characterizing the entity creating a data element in an eCRF
for a clinical investigation. NOTE: Per FDA Final Guidance on eSource, Each data element
is associated with an origination type that identifies the source of its capture in
the eCRF. This could be a person, a computer system, a device, or an instrument that
is authorized to enter, change, or transmit data elements into the eCRF (also sometimes
known as an author). See also data element, data element originator, origin. [CDISC,
Note is from FDA Final Guidance on eSource];
NCI Metathesaurus CUI : CL540445;
Origin ID : C142490;
UMLS CUI : C4684630;
Semantic type(s)
- concept_is_in_subset
