Preferred Label : Non-Interventional Study;
Alternative definition : CDISC-GLOSS: A study where the medicinal product(s) is (are) prescribed in the usual
manner in accordance with the terms of the marketing authorization. The assignment
of the patient to a particular therapeutic strategy is not decided in advance by a
trial protocol but falls within current practice and the prescription of the medicine
is clearly separated from the decision to include the patient in the study. No additional
diagnostic or monitoring procedures shall be applied to the patients and epidemiological
methods shall be used for the analysis of collected data. [Clinical Trial Directive
EC/20/2001 definitions];
NCI Metathesaurus CUI : CL540538;
Origin ID : C142615;
UMLS CUI : C4684718;
Semantic type(s)
- concept_is_in_subset
