Preferred Label : Clinical Study Data Element;
NCIt definition : A data element associated with a clinical study.;
Alternative definition : CDISC-GLOSS: A single observation associated with a subject in a clinical study. A
data element in an eCRF represents the smallest unit of observation captured for a
subject in a clinical investigation. NOTE: Examples include birth date, white blood
cell count, pain severity measure, and other clinical observations made and documented
during a study. Data element identifiers should be attached to each data element as
it is entered or transmitted by the originator into the eCRF. See also eCRF, data
element identifier, data originator, item. [After FDA Guidance for Industry Electronic
Source Data in Clinical Investigations , Body text and Glossary];
NCI Metathesaurus CUI : CL540372;
Origin ID : C142437;
UMLS CUI : C4688474;
Semantic type(s)
- concept_is_in_subset
