Preferred Label : Sponsor-Investigator;
NCIt definition : An individual person who both initiates and conducts, alone or with others, a clinical
trial and under whose immediate direction the investigational product is administered
to, dispensed to, or used by a subject. (FDA);
Alternative definition : CDISC-GLOSS: An individual who both initiates and conducts, alone or with others,
a clinical trial and under whose immediate direction the investigational product is
administered to, dispensed to, or used by a subject. NOTE: The term does not include
any person other than an individual (i.e., it does not include a corporation or an
agency). The obligations of a sponsor-investigator include both those of a sponsor
and those of an investigator. [21 CFR 50.3f] [ICH E6] See also coordinating investigator,
investigator, investigator/institution, principal investigator, site investigator,
sponsor-investigator, sub-investigator.;
NCI Metathesaurus CUI : CL540582;
Origin ID : C142695;
UMLS CUI : C4684779;
Semantic type(s)
- concept_is_in_subset
