Preferred Label : Relevant Regulation Applicable Indicator;
NCIt related terms : RelevantRegulation.applicableIndicator;
Alternative definition : BRIDG 5.3: Specifies whether this study must be registered as required by applicable
laws. EXAMPLE(S): OTHER NAME(S): Section 801 Clinical Trial NOTE(S): Under US Public
Law 110-85, Title VIII, Section 801, applicable drug trials include controlled clinical
investigations, other than Phase I investigations, of a drug or biologic subject to
US FDA regulation. Applicable device clinical trials are controlled trials with health
outcomes of devices subject to FDA regulation, other than small feasibility studies,
and pediatric postmarket surveillance.;
NCI Metathesaurus CUI : CL978156;
Origin ID : C165069;
UMLS CUI : C5236860;
Semantic type(s)
- concept_is_in_subset
