SAE Reconciliation
SCiAN will develop an SAE Reconciliation plan that identifies the variables to be reconciled between the study DB and the Safety DB. SAE reports, CIOMS or MedWatch reports are manually reviewed against the clinical database or SAE listings from the clinical database. Data discrepancies are immediately posted as queries and applied once resolutions are obtained. When studies utilize SCiAN’s EDCPRO and SAEPRO systems, Sponsors can be assured that SAE reconciliation is performed quickly and efficiently.