Learn how to configure your Vault to evaluate the expectedness of adverse events for postmarket products within a clinical trial study.
About the Feature
With the 25R1 release, Vault Safety supports using postmarket datasheets for expectedness evaluations of postmarket products involved in clinical trial studies. You can configure which datasheet type is used in this scenario by agency, giving you flexible and precise evaluations based on differing agency requirements. This is useful for marketed products that have specific datasheets for when that product is used in an investigational study.
After completing the required configuration, learn how to manage Agencies and how Vault prioritizes Datasheets for investigational to marketing scenarios.
Update the Organization Layout
Add the Inv.-Marketed Product Expectedness field to the Organization object layout for the Agency object type.