Preferred Label : Clinical Trial Expedited Safety Report Documentation;
NCIt related terms : Suspected Unexpected Serious Adverse Reaction (SUSAR); Exped Safe Rept; Investigational New Drug (IND) Safety Report; CIOMS Report; MedWatch; Expedited Safety Report;
Alternative definition : CareLex: Documentation that presents and summarizes the relevant findings and notification
by the sponsor of unexpected serious adverse drug reactions and other safety information,
which is submitted to regulatory authorities, investigators, Institutional Review
Boards (IRBs) and/or Independent Ethics Committees (IECs). Reports may include but
are not limited to CIOMS, MedWatch, Electronic Submission of AE Notification to FDA
Reports, Analysis of Similar Events, cover letters, and/or country-specific reporting
forms. [Adapted from TMF-RM]; CDISC: Documentation describing unexpected serious adverse events experienced by the
subject and other safety information in the clinical trial, which are submitted to
regulatory authorities and Institutional Review Boards or Independent Ethics Committees.;
Origin ID : C115574;
UMLS CUI : C3899591;
Semantic type(s)
- concept_is_in_subset
