Learn how to configure your Vault to support PMDA reporting requirements for blinded Study Products.
About the Feature
With the 24R2 release, Vault Safety supports PMDA reporting requirements for blinded Study Products, including evaluating reporting rules. You can now specify the primary blinded investigational Product to substitute for blinded Products. The reporting rule engine then assesses reportability based on the specified Product. In addition, when you generate Case Product Registrations (CPRs) on Localized Cases, Vault considers the primary blinded investigational Product and generates any general and cross reportable investigational CPRs for each blinded Study Product.
Although this feature is Auto-on, some components require additional configuration.
After configuring this feature, see how to specify primary blinded investigational Products in Set Up the Localized Business Admin Library for Japan. For additional details on how this feature works, see Blinded Study Product Reporting in Report to the PMDA.
Update the Study Product Placeholder Layout
Complete the following steps to add the Primary Blinded Investigational Product field to the Study Product Placeholder layout:
- Go to Admin > Configuration > Objects > Study Product Placeholder > Layouts > Study Product Placeholder Detail Page Layout.
- In the Details section, add the Primary Blinded Investigational Product field.
- Select Save.