View audit trail report
The Audit Trail report serves as a comprehensive log of records associated with the approval or rejection of eTMF files. It captures key information such as the user name of those who approved or rejected files, the timestamps of these actions, and so on. This report provides a detailed chronology of events for transparency and traceability, allowing for thorough reviews of system activity during internal audits or external regulatory inspections.
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In the eTMF application header, select the TMF tab.
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In the Study List table that appears, select the needed study.
Figure 1. Selecting study
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In the left pane of the page that opens, select Study Details > Audit Trail.
Figure 2. Audit trail page
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In the Audit Trail table that appears, view the audit trail report.
Figure 3. Viewing audit trail report
Tip
From the table toolbar, you can filter the audit data by study, country, or site.
Figure 4. Sorting audit data
You have viewed the audit trail report for your study. You can also export this report to your computer.