How is the SAE reconciliation performed?

If your team uses programmed listings that compare the specific variables in the two databases, you will receive output based on a predetermined frequency that contains discrepancies between the two databases. Discrepancies are then resolved, and inconsistencies are corrected. Discrepancies are resolved by issuing queries in the clinical and/or Safety databases. Confirm with your team who is responsible for issuing the queries as it falls under the purview of the Safety team at some companies, while DM performs this task at others.

If your team uses manual listings to compare the specific fields between the two databases, you will request/receive listings from the Safety database and compare them to manual listings you generate from the AE dataset of your clinical database and perform the reconciliation that way. In the example above, you will basically be looking at two different listings to make sure the values of the variables identified in the clinical database match the values in the safety database.

File all completed SAE reconciliations and/or emails denoting there was no SAEs for the period under section 10.03.08 of the eTMF.