Enable Expectedness in Aggregate Reports

Learn how to update your Vault’s configuration to enable expectedness in aggregate reports.

About the Feature

The Vault Safety 21R3 release introduced expectedness in aggregate reports. This feature supports evaluating adverse event expectedness within a specific time period, to accurately identify SUSARs in periodic reports. In a Product Datasheet, you can specify the approval date range for each term. When generating a DSUR, PBRER, or PSUR, you can select the relevant Product Datasheet version to evaluate term expectedness in periodic reports.

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).

To learn more about using this feature once enabled, see the following links:

• Manage Datasheets and Auto-Expectedness
• Mark Unexpected Terms in DSUR Reports
• Mark Unexpected Terms in PBRER Reports
• Mark Unexpected Terms in PSUR Reports

Update the Aggregate Reports Object

1. In the Admin area, go to Configuration > Objects > Aggregate Report.
2. From the Layouts tab, edit the Aggregate Report Detail Page Layout (aggregate_report_detail_page_layout__c) to add the following fields:
   • Indicate Unexpected Term
   • Datasheet
     
3. (Optional) If you always want to indicate unexpected terms in aggregate reports, turn the Indicate Unexpected Term field on by default:
   1. From the Layouts tab, open the Indicate Unexpected Term (indicate_unexpected_term__v) field.
   2. Edit the field to set a Default Value of TRUE.

Update the Layout for Datasheets

1. In the Admin area, go to Configuration > Objects > Datasheet.
2. From the Layouts tab, open the Datasheet Detail Page Layout (datasheet_detail_page_layout__c) for editing.
3. Add the following columns to the Expected Adverse Events section (MedDRA Criteria related object section):
   • Active Date Start
   • Active Date End
     

(Optional) Update the Layout for MedDRA Criteria

The following configuration is optional but recommended:

1. In the Admin area, go to Configuration > Objects > MedDRA Criteria.
2. From the Layouts tab, open the MedDRA Criteria Detail Page Layout (meddra_criteria_detail_page_layout__c) for editing.
3. Add the Active Date Start field to the Details section.

Security

Ensure to grant the appropriate object field permissions for the following new fields:

Object	Fields
MedDRA Criteria	Active Date Start Active Date End
Aggregate Report	Indicate Unexpected Term Datasheet

Grant field permissions by navigating to Users & Groups > Permission Sets, and editing the Object Field Permissions from the Objects tab of a permission set.