Learn how to configure your Vault to generate expectedness for blinded Study Products on blinded study Cases.
About the Feature
With the 24R3 release, you can associate Datasheets with Study Product Placeholders so that Vault can generate expectedness for blinded Study Products. When study Cases are blinded, Vault generates Expectedness records for every Study Product Placeholder Datasheet. Because this feature works in Vaults configured to isolate blinded product information, for unblinded Cases, Vault updates expectedness for both the blinded and unblinded records based on the available information. This feature supports only double-blinded clinical trial studies without study arms.
After you have configured this feature, see Manage Datasheets and Auto-Expectedness and How Case Assessment Expectedness is Generated for more information.
Prerequisites
Before configuring this feature in your Vault, you must contact Veeva Managed Services. In addition, you must configure Clinical Trials: Isolate Blinded Product Information.
Configure the Study Product Placeholder Object
To configure the Study Product Placeholder object, update the layout and add the Generate Study Product Datasheets action. To complete these procedures, navigate to Admin > Configuration > Objects > Study Product Placeholder.
Update the Study Product Placeholder Layout
To update the Study Product Placeholder object layout:
- Navigate to the Layouts tab and select Study Product Placeholder Detail Page Layout.
- Insert the Study Product Placeholder Datasheet > Study Product Placeholder related object section.
- In the Datasheets section, we recommend editing the default columns to include:
- Name
- Label/Brochure
- Country
- Core
- Select Save.
Configure the Generate Study Product Datasheets Action
To configure the Generate Study Product Datasheets action on the Study Product Placeholder object, assign the action to the object and then configure a user action on the applicable states of the Study Product Placeholder Lifecycle object lifecycle.