Preferred Label : Study Subject Discontinuation;
NCIt synonyms : Clinical Trial Participant Discontinuation;
NCIt related terms : discontinuation; Study Discontinuation; discontinue (participant);
NCIt definition : The act of concluding participation by an enrolled subject prior to completion of
all protocol-required elements in a trial. NOTE: Four categories of discontinuation
are distinguished: a) dropout: Active discontinuation by a subject (also a noun referring
to such a discontinued subject); b) investigator initiated discontinuation (e.g.,
for cause); c) loss to follow-up: cessation of participation without notice or action
by the subject; d) sponsor initiated discontinuation. Note that subject discontinuation
does not necessarily imply exclusion of subject data from analysis. Termination of
subject has a history of synonymous use, but is now considered nonstandard. [After
ICH E3, section 10.1 and FDA Guidance for Industry: Submission of Abbreviated Reports
& Synopses in Support of Marketing Applications, IV A];
Alternative definition : CDISC: The act of concluding participation by an enrolled subject prior to completion
of all protocol-required elements in a study. NOTE: Four categories of discontinuation
are distinguished: a) dropout: Active discontinuation by a subject (also a noun referring
to such a discontinued subject); b) investigator initiated discontinuation (e.g.,
for cause); c) loss to follow-up: cessation of participation without notice or action
by the subject; d) sponsor initiated discontinuation. Note that subject discontinuation
does not necessarily imply exclusion of subject data from analysis. Termination of
subject has a history of synonymous use, but is now considered nonstandard. [After
ICH E3, section 10.1 and FDA Guidance for Industry: Submission of Abbreviated Reports
& Synopses in Support of Marketing Applications, IV A] (CDISC Glossary); CDISC-GLOSS: The act of concluding participation by an enrolled subject prior to completion
of all protocol-required elements in a study. NOTE: Four categories of discontinuation
are distinguished: a) dropout: Active discontinuation by a subject (also a noun referring
to such a discontinued subject); b) investigator initiated discontinuation (e.g.,
for cause); c) loss to follow-up: cessation of participation without notice or action
by the subject; d) sponsor initiated discontinuation. Note that subject discontinuation
does not necessarily imply exclusion of subject data from analysis. Termination of
subject has a history of synonymous use, but is now considered nonstandard. [After
ICH E3, section 10.1 and FDA Guidance for Industry: Submission of Abbreviated Reports
& Synopses in Support of Marketing Applications, IV A] See also withdrawal.; MRCT-Ctr: To remove a study participant from a study. (https://mrctcenter.org/glossaryterm/discontinue-participant/);
NCI Metathesaurus CUI : CL540380;
Origin ID : C142444;
UMLS CUI : C5667165;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
