Serious AE Consistency

Consistency Between Tables Check

Introduction 

A serious adverse event (SAE) within a study encompasses any medical incident that:

• Results in death
•  Is life-threatening (immediate risk of death)
•  Requires inpatient hospitalization or prolongation of existing hospitalization
•  Results in persistent or significant disability/incapacity
•  Results in congenital anomaly/birth defect

Purpose

Validates that the total number of subjects with a serious AEs is consistent across all different tables in the project.

Applicability 

Inclusion conditions 

Tables with the following keywords “Serious” and  “SAE”

Exclusion 

• Empty table
• Tables are for “Non serious” AE.

Discrepancies

• A mismatch in values between 2 or more applicable tables.

Discrepancy Example