Preferred Label : CDISC General Observation Class;
NCIt related terms : general observation class;
NCIt definition : In the context of the Study Data Tabulation Model (SDTM), a higher level categorization
of the subject-level observation domains. Most CDISC domains are assigned to one of
three general observation classes: 1) The Interventions general observation class
is a domain that captures investigational treatments, therapeutic treatments, and
surgical procedures that are intentionally administered to the subject (usually for
therapeutic purposes) either as specified by the study protocol (e.g., exposure),
coincident with the study assessment period (e.g., concomitant medications), or other
substances self-administered by the subject (such as alcohol, tobacco, or caffeine).
2) The Events general observation class captures occurrences or incidents independent
of planned study evaluations occurring during the trial (e.g., adverse events or disposition)
or prior to the trial (e.g., medical history). 3) The Findings general observation
class captures the observations resulting from planned evaluations such as observations
made during a physical examination, laboratory tests, ECG testing, and sets of individual
questions listed on questionnaires. (SDTM and SDTM Implementation Guide, www.CDISC.org);
Alternative definition : CDISC-GLOSS: In the context of the Study Data Tabulation Model (SDTM), a higher level
categorization of the subject-level observation domains. NOTE: Most CDISC domains
are assigned to one of three general observation classes: 1) The Interventions general
observation class is a domain that captures investigational treatments, therapeutic
treatments, and surgical procedures that are intentionally administered to the subject
(usually for therapeutic purposes) either as specified by the study protocol (e.g.,
exposure), coincident with the study assessment period (e.g., concomitant medications),
or other substances self-administered by the subject (such as alcohol, tobacco, or
caffeine). 2) The Events general observation class captures occurrences or incidents
independent of planned study evaluations occurring during the trial (e.g., adverse
events or disposition) or prior to the trial (e.g., medical history). 3) The Findings
general observation class captures the observations resulting from planned evaluations
such as observations made during a physical examination, laboratory tests, ECG testing,
and sets of individual questions listed on questionnaires. [Based on SDTM and SDTM
Implementation Guide, www.CDISC.org] See also domain, event, intervention, finding.
Compare with special purpose domain.;
NCI Metathesaurus CUI : CL979057;
Origin ID : C165827;
UMLS CUI : C5237468;
Semantic type(s)
- concept_is_in_subset
