loading...| Preferred Name |
Clinical Trial |
| ID |
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C71104 |
| ALT_DEFINITION |
1) 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). 2) A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.(1. modified from ICH E6 Glossary, Directive 2001/20/EC. 2. NIH revised definition 2015) (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. 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] See also clinical study, clinical investigation. |
| code |
C71104 |
| 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 |
| Contributing_Source |
CDISC CDISC-GLOSS CTDC |
| 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. |
| FULL_SYN |
Trial clinical_trial Clinical Trials, Unspecified Trials Clinical Trials Clinical Trial clinical trial |
| label |
Clinical Trial |
| Legacy Concept Name |
Clinical_Trial_Generic |
| Preferred_Name |
Clinical Trial |
| prefixIRI |
Thesaurus:C71104 |
| prefLabel |
Clinical Trial |
| Semantic_Type |
Research Activity |
| UMLS_CUI |
C0008976 |
| subClassOf |