Preferred Label : Clinical Trial Special Events of Interest Documentation;
NCIt related terms : Medical Events of Interest; SEI; Special Events of Interest;
Alternative definition : CareLex: A record of an event experienced by a clinical trial subject and identified
by the protocol as important to monitor. 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 an event of special interest experienced by the subject
in the clinical trial, which is defined by the clinical study protocol.;
Origin ID : C115558;
UMLS CUI : C3897550;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
