Study Monitoring

Preferred Label : Study Monitoring;

NCIt related terms : Trial Monitoring;

NCIt definition : The act of overseeing the progress of a clinical trial and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). (ICH);

Alternative definition : CDISC-GLOSS: The act of overseeing the progress of a clinical study to ensure that it is conducted (and that events are recorded and reported) in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [After ICH E6 Glossary] See also monitoring, subject monitoring, medical monitoring, study monitoring, data monitoring, risk based monitoring.; CDISC: The act of overseeing the progress of a clinical study and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and regulatory requirement(s) where applicable. [after ICH E6 Glossary];

NCI Metathesaurus CUI : CL541320;

Details

Origin ID

C142707;

UMLS CUI

C5441921;

Automatic exact mappings (from CISMeF team)
- Monitor, device (physical object) [SNOMED CT concept]
- Monitoring [DeCS]
- Monitoring [ICNP action]
- methamidophos [MeSH Supplementary Concept]
- monitored [Radlex concept]
- monitoring [IUPAC Term]
- monitoring [ICPS Descriptor]
- monitoring [ICPS Descriptor]
Semantic type(s)
- Research Activity [UMLS semantic type]
UMLS correspondences (same concept)
- Monitoring - action (qualifier value) [SNOMED CT concept]
concept_is_in_subset
- CDISC Glossary Terminology [NCIt concept]
- CDISC Protocol Entities Terminology [NCIt concept]
- CDISC Protocol Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

Main resources

You can consult :

recommendations
documents concerning education
documents for patients