Preferred Label : Low-interventional Clinical Trial;
NCIt definition : A clinical trial that is non-interventional by design but includes diagnostic or monitoring
procedures that carry minimal risk or impact on patients.;
Alternative definition : CDISC-GLOSS: A clinical trial which fulfills all of the following conditions: (a)
the investigational medicinal products, excluding placebos, are authorized; (b) according
to the protocol of the clinical trial, (i) the investigational medicinal products
are used in accordance with the terms of the marketing authorization; or (ii) the
use of the investigational medicinal products is evidence-based and supported by published
scientific evidence on the safety and efficacy of those investigational medicinal
products in any of the Member States concerned; and (c) the additional diagnostic
or monitoring procedures do not pose more than minimal additional risk or burden to
the safety of the subjects compared to normal clinical practice in any Member State
concerned. [REGULATION (EU) No 536/2014 Article 2.2.(3)];
NCI Metathesaurus CUI : CL540566;
Origin ID : C142601;
UMLS CUI : C4684707;
Semantic type(s)
- concept_is_in_subset
