Preferred Label : Study Subject Status Code;
NCIt related terms : StudySubject.statusCode;
NCIt definition : A coded value specifying the phase in the lifecycle of the study subject.;
Alternative definition : BRIDG 3.0.3: A coded value specifying the phase in the lifecycle of the study subject.
EXAMPLE(S): candidate, eligible, follow-up, ineligible, not registered, off-study,
on-study, pending on-study, potential candidate, screening, withdrawn. NOTE(S): Please
refer to the Study Subject Status state transition diagram for further details.; BRIDG 5.3: A coded value specifying the phase in the lifecycle of the study subject.
EXAMPLE(S): candidate, eligible, follow-up, ineligible, not registered, off-study,
on-study, pending on-study, potential candidate, screening, withdrawn OTHER NAME(S):
NOTE(S): Please refer to the Study Subject Status state transition diagram for further
details. If in CDISC's SDTM DM.ACTARMCD NOTRT (meaning Not Treated), this is a subject
who passed eligibility, was assigned a treatment but never started, e.g. withdrew
before treatment started, etc., so a PerformedExperimentalUnitAllocation exists for
this subject. If in CDISC's SDTM DM.ACTARMCD NOTASSGN (meaning Not Assigned), this
is a case where DMARM DMACTARM, meaning after eligibility was determined, the subject
may be left over/unneeded, or withdraws, or doesn't pass further eligibility criteria,
or is in a wait period between eligibility/intake and assignment - all are possible
statusCode values. And all those values could be fine grained statuses in a BRIDG-based
system that each roll up into NOT ASSIGNED to be reported in SDTM data sets. In this
case PerformedExperimentalUnitAllocation doesn't exist.;
Origin ID : C94293;
UMLS CUI : C2986461;
Semantic type(s)
- concept_is_in_subset
