Preferred Label : Serious Adverse Event Report;
NCIt related terms : SAE Report; SAE Rept;
NCIt definition : Records describing a serious adverse event that occurred during a clinical trial.;
Alternative definition : CareLex: Documentation that describes an adverse event in clinical trial which is
serious, as defined in the protocol. Reports may include but are not limited to specific
regulatory forms and supporting data, reporter correspondence, associated note-to-files,
source documentation, case logs, narratives, case unblinding forms, and/or safety
database case printouts. [Adapted from TMF-RM];
Origin ID : C115587;
UMLS CUI : C3897642;
Semantic type(s)
- concept_is_in_subset
