Regulatory Submission

Preferred Label : Regulatory Submission;

NCIt related terms : Submission; Reg Subm;

Alternative definition : CareLex: An assembly of one or more regulatory submission units supporting a specific regulatory purpose or decision. In most cases, the compilation of the submission units is utilized in the assessment of a regulated medical product quality, safety and/or effectiveness. [NCI]; CDISC: An assembly of one or more regulatory submission units supporting a specific regulatory purpose or decision. In most cases, the compilation of the submission units is utilized in the assessment of a regulated medical product quality, safety and/or effectiveness.;

Details

Origin ID

C70885;

UMLS CUI

C2347939;

Automatic exact mappings (from CISMeF team)
- Submission [LOINC System]
- Submissiveness [ICD-11 Subcategory]
Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- CDISC Define-XML ODM Context Terminology [NCIt concept]
- CDISC Define-XML Terminology [NCIt concept]
- CareLex eTMF 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