Preferred Name | Clinical Trial | |
Synonyms |
clinical trial Interventional Study Interventional Clinical Trial Clinical Trials, Unspecified Clinical Trials Clinical Trial clinical_trial Trial Trials |
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Definitions |
A research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. |
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ID |
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C71104 |
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ALT_DEFINITION |
A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions. The EU clinical trial regulations include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects in its criterion. [after ICH E6 [R2]; EU CTR 2014] See also clinical study, clinical investigation. A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [After ICH E6 [R2], EU CTR 2014] (CDISC Glossary) A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [After ICH E6 [R2], EU CTR 2014] See also clinical study, clinical investigation, randomized controlled trial (RCT). |
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code |
C71104 |
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Concept_In_Subset |
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C173071 http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C132298 http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61410 |
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Contributing_Source |
CDISC-GLOSS CDISC CTDC |
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DEFINITION |
A research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. |
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FULL_SYN |
clinical trial Interventional Study Interventional Clinical Trial Clinical Trials, Unspecified Clinical Trials Clinical Trial clinical_trial Trial Trials |
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label |
Clinical Trial |
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Legacy Concept Name |
Clinical_Trial_Generic |
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Preferred_Name |
Clinical Trial |
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prefixIRI |
Thesaurus:C71104 |
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Semantic_Type |
Research Activity |
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UMLS_CUI |
C0008976 |
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subClassOf |