What do you understand by SAE reconciliation and why do we need SAE reconciliation ?
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What do you understand by SAE reconciliation and why do we need SAE reconciliation ?
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SAE reconciliation is done for clinical trial cases. In SAE reconciliation we compare ARGUS
database versus investigators database to find discrepancies in coding of serious adverse events (SAE).
For this we enter the protocol ID or trial drug information in search field.
The purpose of SAE reconciliation is to compare the safety databases like ARGUS database with clinical database for clinical trial cases in order to find out any discrepancy in coding of serious adverse events.
SAE reconciliation is the process of comparison between Clinical trial Database and Drug Safety Database (Argus) to find out the discrepancies in coding Serious Adverse events. In this process we enter Protocol ID and basic drug Information to search.