Preferred Label : Investigational Medicinal Product;
NCIt related terms : Investigational Product; investigational medicine; IMP;
NCIt definition : A pharmaceutical form of an active ingredient being tested or used as a reference
in a clinical trial, including a product with a marketing authorization when used
or assembled (formulated or packaged) in a way different from the approved form, or
when used for an unapproved indication, or when used to gain further information about
an approved use. Reference products and placebos are also considered investigational
medicinal products in a clinical trial. [After E6(R2) Good Clinical Practice (GCP)
-- Step 4 (final), 9 November 2016 -- Glossary];
Alternative definition : CDISC-GLOSS: A pharmaceutical form of an active ingredient being tested or used as
a reference in a clinical trial, including a product with a marketing authorization
when used or assembled (formulated or packaged) in a way different from the approved
form, or when used for an unapproved indication, or when used to gain further information
about an approved use. Reference products and placebos are also considered investigational
medicinal products in a clinical trial. [After E6(R2) Good Clinical Practice (GCP)
-- Step 4 (final), 9 November 2016 -- Glossary] See also authorised investigational
medicinal product, experimental intervention.; MRCT-Ctr: A treatment or drug that is not yet approved for the condition being studied.
(https://mrctcenter.org/glossaryterm/investigational-medicine/); CDISC: A medicinal product which is being tested or used as a reference, including
as a placebo, in a clinical trial. (Regulation (EU) No 536/2014 Article 2 (5));
NCI Metathesaurus CUI : CL1921887;
Origin ID : C202579;
UMLS CUI : C5908626;
Semantic type(s)
- concept_is_in_subset
