SAE Reconciliation
Consistency between Study DB and Safety DB
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.