Failure to Report or Delayed Reporting of an Adverse Event That Would Require Filing an Expedited Adverse Event (AE) Report

**Semantic type:** Conceptual Entity

**Definition:** A study procedure deviation of failure to report or delayed reporting of an adverse event that would require filing an expedited adverse event (AE) report.

**Synonyms:** - Failure to report or delayed reporting of an adverse event that would require filing an expedited Adverse Event (AE) report