Phase IV Trial

Preferred Label : Phase IV Trial;

NCIt synonyms : Phase 4 Study; Phase IV Study; Clinical Trials, Phase IV; Phase IV Clinical Trials;

NCIt related terms : 4; Trial Phase 4; Phase 4;

NCIt definition : A randomized, controlled trial that is designed to evaluate the long-term safety and efficacy of a drug for a given indication. Often they are designed to study side effects that may have become apparent after the phase III study was completed.;

Alternative definition : CDISC-GLOSS: Post-approval studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: Phase 4 studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [after FDA CDER handbook, ICH E8] See also phase.; CDISC: Post-approval studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: Phase 4 studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [after FDA CDER handbook, ICH E8] See also phase. (CDISC Glossary); NCI-GLOSS: After a treatment has been approved and is being marketed, it is studied in a phase IV trial to evaluate side effects that were not apparent in the phase III trial. Thousands of people are involved in a phase IV trial.; ICH: Post-approval trials conducted to further understand the safety and efficacy of the drug in its approved indication. They are not considered necessary for approval but are often important for optimising the drug's use.;

Codes from synonyms : CDR0000045835; ICH M11-Trial Phase;

Details

Origin ID

C15603;

UMLS CUI

C0282462;

Automatic exact mappings (from CISMeF team)
- -4 (qualifier value) [SNOMED CT concept]
- 4 (qualifier value) [SNOMED CT concept]
- Arabic numeral 4 (qualifier value) [Inactive SNOMED CT concept]
- Phase 4 [ICD-11 Extension code]
- Phase 4 (qualifier value) [SNOMED CT concept]
- adenosylhomocysteinase like 1 [HGNC gene]
- clinical trials, phase iv as topic [MeSH Descriptor]
- inositol 1,4,5-triphosphate receptor associated 1 [HGNC gene]
- inositol polyphosphate phosphatase like 1 [HGNC gene]
- inositol polyphosphate-5-phosphatase A [HGNC gene]
- inositol polyphosphate-5-phosphatase B [HGNC gene]
- phase 4 [COVID-19 Thesaurus concept]
- synaptojanin 1 [HGNC gene]
- synaptojanin 2 [HGNC gene]
Currated CISMeF NLP mapping
- clinical trial, phase IV [MeSH concept]
- clinical trial, phase iv [MeSH publication type]
Semantic type(s)
- Research Activity [UMLS semantic type]
UMLS correspondences (same concept)
- clinical trials, phase IV as topic [MeSH concept]
- clinical trials, phase iv as topic [MeSH Descriptor]
concept_is_in_subset
- CDISC Glossary Terminology [NCIt concept]
- CDISC Protocol Terminology [NCIt concept]
- CDISC SDTM Terminology [NCIt concept]
- CDISC SDTM Trial Phase Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]
- ICH M11 Terminology [NCIt concept]
- ICH M11 Trial Phase Value Set Terminology [NCIt concept]
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

Main resources

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