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Asked: 2023-01-03T10:45:00+00:00 In:

Explain SAE reconciliations

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Explain SAE reconciliations
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    1. SAE reconciliation is a process in which listings from Safety DB (PV) will be reviewed along with AE data listings from the clinical database. To ensure all data reported is consistent across systems.
      Variables Like “AE term” (not an exact match though), “Start date”, “Stop date”, “Ongoing”, “Action taken”, “Casualty”, “Outcome”, etc. are compared AE Vs SAE Listings
      If there is any discrepancy b/w these are raised as queries to the site, based on the response, either Clinical or PV (Argus) is updated.

      Generally, there will be a tracker that will be maintained which is called an SAE tracker which is a corresponding document for communication, and actions that are taken on each SAE case will be reported, and this will be saved as documentation and archived in DMS.

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    2. SAE reconciliation is a process where in clinical database is compared with Safety database. To ensure that the data reported is accurate all the variables like start date, stop date, ongoing, action taken, causality etc are compared between AE and SAE listings. If any discrepancy is found a query is raised to the site. Depending on this query response appropriate communication is made with safety department via safety tracker or SAE tracker, and based on the response, either Clinical or PV (Argus) is updated. This tracker/communication document is saved to DMS.

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