Learn how to configure your Vault to support creating Study Product Datasheets.
About the Feature
To support clinical trial studies with multiple products and different expected Adverse Events, Vault Safety now includes Study Product Datasheets. When Admins configure Datasheets for individual study products, the system generates Expectedness at a more granular level, removing the need for Case Processors to verify Expectedness manually. In addition, Expectedness evaluations now consider adverse event onset dates for Clinical Trial Study Cases, which enhances support for regulatory and aggregate reporting.
Once you enable this feature, see Manage Datasheets and Auto-Expectedness for more information.
Update the Study Product Layout
Add the Study Product Datasheet field to the Study Product layouts used by your organization. The following steps describe updating the Drug Page Layout, but can be followed for any applicable layout.
- Go to Admin > Configuration > Objects > Study Product > Layouts.
- Select Drug Page Layout.
- In the Details section, add the Study Product Datasheet field.
- Select Save.