Clinical Trial Notification of Safety or Other Trial Information Documentation

Preferred Label : Clinical Trial Notification of Safety or Other Trial Information Documentation;

NCIt related terms : Notification to Regulatory Authority of Safety/Trial Information; Notification of Safety Information; Safety Report; Notf Safe Info; Notification of Safety or Trial Information;

Alternative definition : CareLex: Notification to Regulatory Authorities of any trial events that could adversely affect the safety of subjects, impact the conduct of the trial or alter the regulatory authority's approval/favorable opinion to continue the trial. Notifications may include but are not limited to Quarterly line listings, suspected unexpected serious adverse reactions (SUSARs), Council for International Organizations of Medical Sciences (CIOMS), MedWatch, Analysis of Similar Events, Serious Breaches, cover letters and/or country-specific reporting forms. [TMF-RM]; CDISC: Documentation submitted to the regulatory authorities pertaining to any events that may impact the safety of subjects or the conduct of the clinical trial.;

Details

Origin ID

C115551;

UMLS CUI

C3889274;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- CDISC TMF Terminology [NCIt concept]
- CDISC TMF-RM Regulatory Zone 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