Preferred Label : Clinical Trial Serious Adverse Event Report Documentation;
NCIt related terms : SAE Report; SAE Rept; Serious Adverse Event Report;
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]; CDISC: Documentation describing a serious adverse event experienced by the subject
in the clinical trial, which is defined by the clinical study protocol.;
Origin ID : C115587;
UMLS CUI : C3897642;
Semantic type(s)
- concept_is_in_subset
