Learn how to configure your Vault to to support unauthorized Auxiliary Medicinal Products (AxMPs).
About the Feature
With the 25R1 release, Vault provides the ability to generate the CTIS Annual Safety Report in addition to the standard report, both of which meet regulatory requirements from the associated agency. This feature introduces a report-level Submission Format picklist for Annual Safety Report formatting that allows users to choose between the standard DSUR and the CTIS Annual Safety Report. When a user selects CTIS Annual Safety Report for this field value, the generated DSUR includes unauthorized Auxiliary Medicinal Products (AxMPs) in the Interval Line Listings of Serious Adverse Reactions report and hides Subject ID values in the following reports:
- Interval Line Listings of Serious Adverse Reactions
- Appendix: List of Subjects Who Died During the Reporting Period
After you have configured this feature, see Create DSUR Aggregate Reports for more information.
Update the Aggregate Report Object Layout
To update the Aggregate Report object layout, add the Submission Format picklist field to the Aggregate Report object layout after the Datasheet field.
Update the Study Product Object Layout
To update the Study Product object layout, add the Auxiliary Medicinal Product Status picklist field to all Study Product object layouts.
Update the Study Product Country Object Layout
To update the Study Product Country object layout, add the AxMP Status Override picklist field to the object layout.