Preferred Label : Clinical Development Plan;
NCIt related terms : ClinicalDevelopmentPlan;
NCIt definition : A descriptive record of the clinical investigations to be executed with a particular
treatment, substance or device. This is usually done to obtain marketing approval.;
Alternative definition : CDISC-GLOSS: A document that describes the collection of clinical studies that are
to be performed in sequence, or in parallel, with a particular active substance, device,
procedure, or treatment strategy, typically with the intention of submitting them
as part of an application for a marketing authorization. NOTE: The plan should have
appropriate decision points and allow modification as knowledge accumulates. [from
ICH E9] See also development plan.; BRIDG 5.3: An ordered program of clinical trials, each with specific objectives. This
plan describes the collection of clinical studies that are to be performed in sequence,
or in parallel, with a particular active substance, device, procedure, or treatment
strategy, typically with the intention of submitting them as part of an application
for a marketing authorization. (Adapted from ICH E8, E9) EXAMPLE(S): OTHER NAME(S):
NOTE(S): The plan should have appropriate decision points and allow modification as
knowledge accumulates.;
NCI Metathesaurus CUI : CL540397;
Origin ID : C142424;
UMLS CUI : C4684592;
Semantic type(s)
- concept_is_in_subset
