Learn how to configure your Vault to map adverse event expectedness rationales on Datasheets to Case Assessments and Localized Case Assessments.
About the Feature
With the 24R3 release, Vault Safety supports adding rationales for adverse event expectedness to Datasheets. When populated, Vault copies text in the new Expectedness Justification field on Datasheets and populates the text in the same field on Case Assessments and Localized Case Assessments. This feature supports users when entering expectedness justifications in the J2.11 Other References data element of PMDA E2B(R3) reports.
After you have configured this feature, see the following articles for more information:
- Manage Datasheets and Auto-Expectedness
- Enter Case Data
- Prepare a Localized Case
- Complete Intake and Process Cases for the PMDA
Update Object Layouts
To support this feature, you must add the Expectedness Justification field to the applicable layouts for the following objects:
- Case Assessment Expectedness
- Localized Case Assessment
- MedDRA Criteria for the Datasheet Criteria object type
To add the field:
- Navigate to Admin > Configuration > Objects > [Object] > Layouts > [layout].
- In the Details section, add the Expectedness Justification field.
- Select Save.