TMF-RM Safety Documentation Section

Preferred Label : TMF-RM Safety Documentation Section;

NCIt related terms : Safe Docn Subcat; Safety Documentation Subcategory; Safety Documentation;

NCIt definition : The Trial Master File Reference Model section that contains a collection of documents related to the safety management and reporting for the clinical trial.;

Alternative definition : CareLex: Subcategory name for the eTMF domain containing safety reporting documents for a clinical trial including but not limited to the Safety Management plan.; CDISC: A collection of documents related to the safety management and reporting for the clinical trial.;

Details

Origin ID

C115630;

UMLS CUI

C3899555;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- CDISC TMF Terminology [NCIt concept]
- CDISC TMF-RM Sections Terminology [NCIt concept]
- CareLex eTMF Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

You can consult :

recommendations
documents concerning education
documents for patients