Preferred Label : Clinical Trial Inspection;
NCIt related terms : inspection;
NCIt definition : The act by a regulatory authority(ies) of conducting an official review of documents,
facilities, records, and any other resources that are deemed by the authority(ies)
to be related to the clinical trial and that may be located at the site of the trial,
at the sponsor's and/or contract research organization's (CRO's) facilities, or at
other establishments deemed appropriate by the regulatory authority(ies). (ICH);
Alternative definition : CDISC-GLOSS: The act by a regulatory authority(ies) of conducting an official review
of documents, facilities, records, and any other resources that are deemed by the
authority(ies) to be related to the clinical trial and that may be located at the
site of the trial, at the sponsor's and/or contract research organization's (CRO's)
facilities, or at other establishments deemed appropriate by the regulatory authority(ies).
[ICH] See also audit.;
NCI Metathesaurus CUI : CL545939;
Origin ID : C142448;
UMLS CUI : C4553631;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
