A Quick Dive into SAE Reconciliation

Serious Adverse Event (SAE) reconciliation is a critical aspect of clinical data management, particularly in the context of clinical trials and pharmacovigilance. SAEs are adverse events that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in persistent or significant disability/incapacity, or cause congenital anomaly/birth defect.

At the end of this lesson, we’ll cover:

1. What Sae reconciliation is?
2. Why it is necessary.
3. How it is performed.