About the Feature
With 23R3, Vault Safety supports configuring Adverse Event terms on Datasheets and Watchlists at any level of the MedDRA hierarchy. Previously, terms could be coded at the Preferred Term (PT) and Lower Level Term (LLT) levels only. When coding Adverse Events on Cases, any MedDRA LLT is considered a match if it is listed on or falls under the hierarchy of the term on the Datasheet or Watchlist.
This feature is Auto-on, however, Admins may apply optional additional configuration to their Vault.
For organizations that do not use Vault Safety’s aggregate reporting features, you may choose to update the MedDRA Criteria page layout to exclude the Include Lower Levels field. This field is now used to determine whether lower-level MedDRA terms are included only when evaluating expectedness during aggregate reporting (DSUR, PBRER, and PSUR).
For more information about this feature, see Manage Datasheets and Auto-Expectedness: Manage Expected Adverse Events on a Datasheet and Configure Adverse Event Watchlists: Add MedDRA Terms.
(Optional) Update the MedDRA Criteria Page Layout
To remove the Include Lower Levels field, update the following page layouts:
- MedDRA Criteria Detail Page Layout
- MedDRA Query Criteria Detail Page Layout
Complete the following steps to update each page layout:
- Go to Admin > Configuration > Objects > MedDRA Criteria > Page Layouts.
- Select a page layout.
- In the Details section, remove the Include Lower Levels field.
- Select Save.
