View audit trail of MedDRA synonyms
The Audit Trail feature in the PV application is essential for ensuring regulatory compliance and maintaining the integrity of data. It is a chronological record that provides a short and unalterable history of all activities performed on the PV data. The audit trail serves as an electronic documentation of all actions taken in the system, including data entry, updates, and deletions.
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In the PV application header, select the CONFIGURATION tab.
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In the left pane, select MedDRA Synonym.
Figure 1. Accessing MedDRA synonym configuration
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On the MedDRA Synonym page that opens, do one of the following:
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To view the audit trail of all MedDRA synonyms at once: from the workspace toolbar, select Audit Trail
.
Figure 2. Selecting to view MedDRA synonym list audit trail
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To view the audit trail of a specific MedDRA synonym individually: next to the needed MedDRA synonym, in the Actions column, select More
> Audit Trail .
Figure 3. Selecting to view individual MedDRA synonym audit trail
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In the Audit Trail dialog that opens, view the details of any changes made to the MedDRA synonym(s), including the action performed and its type, the name of the user who made the action, and the date and time at which the action took place.
Figure 4. Viewing audit trail for all MedDRA synonyms
You have viewed the audit trail for all/selected MedDRA synonyms. To obtain more detailed and comprehensive information about the changes made to the MedDRA synonyms, consider accessing the Change History instead.