Preferred Label : Clinical Trial Notification to Investigators of Safety Information Documentation;
NCIt related terms : Notification to Investigators of Safety Information; Safety Letter; Notf Invstgr Safe Info; SUSAR Notification;
Alternative definition : CareLex: Documentation of prompt notification to investigators of all findings of
a clinical trial, including but not limited to new, important information on serious
adverse events and/or safety concerns that could adversely affect the safety of subjects,
impact the conduct of the trial, or alter the approval/favorable opinion of the Institutional
Review Board (IRB)/Independent Ethics Committee (IEC), 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, cover letters and/or country-specific
reporting forms. [Adapted from TMF-RM]; CDISC: Documentation verifying distribution and receipt of the communications related
to the safety of the clinical trial to the investigators.;
Origin ID : C115663;
UMLS CUI : C3899564;
Semantic type(s)
- concept_is_in_subset
