Preferred Label : Clinical Trial Exemption;
NCIt related terms : clinical trial exemption (CTX);
NCIt definition : A process that allows sponsors to apply for approval for each clinical study while
granting an exemption from the requirement to hold a clinical trial certificate (CTC).;
Alternative definition : CDISC-GLOSS: A scheme that allows sponsors to apply for approval for each clinical
study in turn, submitting supporting data to the Medicines Control Agency (MCA), which
approves or rejects the application (generally within 35 working days). NOTE: Approval
means that the company is exempt from the requirement to hold a clinical trial certificate
(CTC). [UK];
NCI Metathesaurus CUI : CL540378;
Origin ID : C142446;
UMLS CUI : C4684603;
Semantic type(s)
- concept_is_in_subset
