Learn how to configure your Vault to include age and sex criteria during Expectedness evaluations.
About the Feature
With the 24R1 release, Vault Safety supports age and sex as qualifiers for Adverse Event Expectedness evaluations during Case processing. These demographic details can be configured on Datasheets for each MedDRA term, when required. This feature eliminates the need for Case Processors to confirm Expectedness evaluations with Datasheets outside of Vault Safety.
After configuring this feature, see Manage Datasheets and Auto-Expectedness: Add Expected Adverse Events (MedDRA Criteria) and Use MedDRA Queries: Add MedDRA Queries to a Datasheet for more information.
With the 24R2 release, Vault considers Datasheet criteria including age and sex demographics when calculating expectedness for some aggregate reports (CIOMS II, DSUR, PBRER, and PSUR).
Update the Datasheet Layout
Update the columns on the Datasheet layout as follows:
- Go to Admin > Configuration > Objects > Datasheet > Layouts > Datasheet Detail Page Layout.
- In the Expected/Unexpected Event Terms section, select Edit Default Columns and add the following columns in this order after the Active Date End column:
- Sex
- Age Range Start
- Age Range Start (Unit)
- Age Range End
- Age Range End (Unit)
- Select Done.
- Select Save.
Update the MedDRA Criteria Layout
Update the fields on the MedDRA Criteria layout as follows:
- Go to Admin > Configuration > Objects > MedDRA Criteria > Layouts > Datasheet Criteria Detail Page Layout.
- In the Details section, add the following fields:
- Sex
Age Range Start- Age Range End
- Select Save.