C115698Level 5
Institutional Review Board Independent Ethics Committee Notification of Safety Information Documentation
**Semantic type:** Intellectual Product
**Definition:** Documentation submitted to the Institutional Review Board or Independent Ethics Committee detailing the safety of subjects in the clinical trial.
**Synonyms:** - Notf IRB-IEC Safe Info - Notification to IRB or IEC of Safety Information - Notification to IRB-IEC of Safety Information - Notification to Institutional Review Board Independent Ethics Committee of Safety Information - Notification to Regulatory Authority of Safety/Trial Information - Safety Report
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