SAE Reconciliation

Oh Oh! that’s what you hear from the folks who does the Serious Adverse Event Reconciliation.  Fight (and politics) between the DM and PV never could reconcile. So does the SAE Reconciliation.

Hospitalization but Resolved. – DM said

Nooo, it wasn’t. Onset of Renal Failure is after Prior Dose. – PV denied.

Six categories of Serious Adverse Events (SAE)
AECAN -ae cancer
AECONG – ae congenital anomaly or birth defect
AEDIS – ae disability (significant
AEDTH- ae death
AELT – ae life threatening
AEHOSP- ae hospitalized

If AE is marked Serious, it suppose to fall under any these 6 category.

Attachment(s):

Sample SAE Reconciliation Format.

Process workflow