What is SAE Reconciliation?

During our CRF development tutorial, we discussed the standard CRFs required for each study. These CRFs include the Adverse Event or AE CRF. The AE CRF is developed to collect data for any untoward medical occurrences or side effects experienced by patients during the trial. For an AE to be considered “serious”, in the view of either the investigator or sponsor, it has to result in any of the following outcomes. The AE has to:

1. Result in death.
2. Be life-threatening.
3. Require prolonged hospitalization or prolongs existing hospitalization.
4. Result in persistent or significant disability/incapacity.
5. Cause a congenital anomaly/birth defect.
6. Require intervention to prevent permanent impairment or damage.

While we collect the AE data, on the AE CRF in the Clinical database, the AE data is also captured in a separate database developed and maintained by the Safety (or Pharmacovigilance) team. To ensure that essential SAE patient data entered in the Clinical database matches the corresponding patient data in the Safety database, we periodically perform a reconciliation between the two databases. This process of reconciling specific fields and variables between the Clinical and the Safety database is called SAE Reconciliation.

Functional Areas affected by this task

• Clinical Data Management
• Safety/Pharmacovigilance