Serious Adverse Events (SAE) information collected during interventional or non-interventional clinical trials are captured in two distinct databases; a clinical database reflecting adverse event information recorded in the Case Report Form (CRF) and a safety database containing information collected on the SAE Form and their respective follow ups. Making sure that the information pertaining to SAEs is matched in these two databases during the course of the study and particularly at the time of study database lock is a challenge impacting data quality, operations performance and compliance.
The parallel processing of SAEs in two different data sources may create discrepancies that need to be clarified and reconciled before the clinical database is locked. When reconciliation occurs, verbatim descriptions, coding terms, treatment and event onset/resolution dates, causality assessment, seriousness criteria, SAE outcome and other information can be found to be different. Based on each company’s standards, some discrepancies must be resolved and others have a predefined margin of tolerance, but all must be compared, weighted, clarified and, if needed, queried and corrected in either dataset before the clinical database lock at the end of the trial. During the SAE Reconciliation process, a separate set of queries are therefore sent to the sites for clarification of identified discrepancies.
In practice, the routine steps of the reconciliation process consist of retrieving the SAE-related data from each of the two databases, usually exporting the data onto listings or Excel files and subsequently comparing the individual data points by navigating from one file