Sponsor procedure describing how to reconcile a clinical trial database with a pharmacovigilance database.

If you use a clinical trial database and a pharmacovigilance database in your study, it is recommended to regularly reconcile data on serious adverse events and adverse events of special interest (reconcile means compare the information such as SAE term, onset date, outcome...). This ensures data integrity and that no such important event is missed (e.g. outcome fatal in one database and resolved in the other database could mean you missed a death/SAE). If you don't use 2 databases, you don't need to reconcile. In our studies this process was performed at the Sponsor level, but you can adapt to do it at site level instead depending on your organisation. We used the procedure to provide the general structure to the process and a reconciliation plan to document the details that may change during the study (see reconciliation plan PV-TB-D18). You can also choose to have everything in the same document.

Target user: Sponsor (can be adapted to be done by the site)