Learn how to configure your Vault for evaluating the reportability of Investigational Medicinal Products (IMPs) for a specific country.
About the Feature
With the 24R3 release, Vault supports enhanced selection of Investigational Medicinal Products (IMPs) on a country-specific basis. When an investigational product is used exclusively in a particular study country, Vault can evaluate reportability on a Product-Country basis. This prevents over-reporting to health authorities and ensures regulatory compliance.
After you have configured this feature, see Manage Studies for more information on configuring studies with country-specific IMPs.
Update the Study Product Object
To configure the Study Product object, enable the Display in Business Admin option and update the layouts. To complete these procedures, navigate to Admin > Configuration > Objects > Study Product.
Display Study Products in Business Admin
Complete the following steps to display Study Product Countries in the Business Admin area:
- Navigate to the Details tab and select Edit.
- Under Options, select Display in Business Admin.
- Select Save.
Update the Study Product Layouts
Complete the following steps to add the Study Product Countries section to the following layouts:
- Study Product Detail Page Layout
- Biologic Page Layout
- Device Detail Page Layout
- Drug Page Layout
- External Product Page Layout
- Vaccine Detail Page Layout
- Navigate to the Layouts tab and select the appropriate layout.
- Insert the Study Product Country related object section.
- Insert a Detail Form section with the Section Label “Study Product Countries”.
- In the Study Product Countries section, edit the default columns to include:
- Study Product
- Study Registration
- Study Product Role Override
- Select Save.