Clinical Trial Expedited Safety Report Documentation

**Semantic type:** Intellectual Product

**Definition:** 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.

**Synonyms:** - CIOMS Report - Exped Safe Rept - Expedited Safety Report - Expedited Safety Report - Investigational New Drug (IND) Safety Report - MedWatch - Suspected Unexpected Serious Adverse Reaction (SUSAR)