Study on Hold - CISMeF

Preferred Label : Study on Hold;

NCIt synonyms : Clinical Hold; Study Suspended; Study on-Hold; Study on Hold Status;

NCIt related terms : clinical hold (of a clinical trial);

NCIt definition : A clinical study status designating that an order has been issued to a study sponsor to delay a proposed investigation or to suspend an ongoing one. When a proposed study is placed on clinical hold, subjects may not be given the investigational product as part of the study. When an ongoing study is placed on clinical hold, no new subjects may be recruited to the study and placed on the investigational product. Subjects already in the study have to stop receiving therapy involving the investigational agent unless the FDA specifically permits it.;

Alternative definition : CDISC-GLOSS: An order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. NOTE: The clinical hold order may apply to one or more of the investigations covered by an IND. [21 CFR 312.42] See also suspension (of a clinical trial), termination (of a clinical trial), temporary halt (of a clinical trial).;

Details

Origin ID

C70755;

UMLS CUI

C2348572;

Semantic type(s)
- Functional Concept [UMLS semantic type]
concept_is_in_subset
- CDISC Glossary Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

Main resources

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