Preferred Name |
Clinical Trial |
|
Synonyms |
clinical trial Clinical Trials, Unspecified Clinical Trials Clinical Trial Trial |
|
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. |
|
ID |
http://purl.obolibrary.org/obo/NCIT_C71104 |
|
ALT_DEFINITION |
A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. 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. 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) |
|
code |
C71104 |
|
Contributing_Source |
CDISC-GLOSS CDISC |
|
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. |
|
has exact synonym |
clinical trial Clinical Trials, Unspecified Clinical Trials Clinical Trial Trial |
|
imported from | ||
in subset |
http://purl.oboInOwllibrary.org/oboInOwl/NCIT_C132298 http://purl.oboInOwllibrary.org/oboInOwl/NCIT_C61410 |
|
label |
Clinical Trial |
|
Legacy_Concept_Name |
Clinical_Trial_Generic |
|
Preferred_Name |
Clinical Trial |
|
prefixIRI |
NCIT:C71104 |
|
prefLabel |
Clinical Trial |
|
Semantic_Type |
Research Activity |
|
UMLS_CUI |
C0008976 |
|
subClassOf |