Preferred Label : Phase IIIb Trial;
NCIt synonyms : Trial Phase IIIB;
NCIt related terms : phase 3b; 3B; Trial Phase 3B;
NCIt definition : A type of Phase III trial executed near the time of approval to elicit additional
findings. This type of trial may be required as a condition of regulatory authority
approval.;
Alternative definition : CDISC: Later Phase 3 trial done near the time of approval to elicit additional findings.
NOTE: Dossier review may continue while associated Phase 3b trials are conducted.
These trials may be required as a condition of regulatory authority approval. Phase
3a is in common usage but not reflected in regulatory guidance. (CDISC Glossary); CDISC-GLOSS: Later Phase 3 trial done near the time of approval to elicit additional
findings. NOTE: Dossier review may continue while associated Phase 3b trials are conducted.
These trials may be required as a condition of regulatory authority approval. Phase
3a is in common usage but not reflected in regulatory guidance. See also phase, phase
3.;
Origin ID : C49689;
UMLS CUI : C1706097;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
