Risk Based Monitoring

Preferred Label : Risk Based Monitoring;

NCIt synonyms : Risk-Based Monitoring;

NCIt related terms : Risk Monitoring;

NCIt definition : An approach to clinical trial monitoring that involves identifying, assessing, monitoring and mitigating the risks that could affect the quality or safety of a study.;

Alternative definition : CDISC-GLOSS: Study monitoring that focuses on preventing or mitigating important and likely risks to investigation quality, including risks to human subject protection and data integrity. [After FDA Guidance: A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers, 2019] See also monitoring.; CDISC: Study monitoring that focuses on preventing or mitigating important and likely risks to investigation quality, including risks to human subject protection and data integrity. [After FDA Guidance: A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers, 2019] (CDISC Glossary);

NCI Metathesaurus CUI : CL540599;

Details

Origin ID

C142674;

UMLS CUI

C4684763;

Semantic type(s)
- Governmental or Regulatory Activity [UMLS semantic type]
concept_is_in_subset
- CDISC Glossary Terminology [NCIt concept]
- CDISC Protocol Study Monitoring Attribute 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 :

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