Enable Expectedness in Aggregate Reports

Learn how to update your vault's configuration to enable expectedness in aggregate reports.

Last Updated Apr 29, 2022

Note Beginning with 24R1 in April 2024 and for all subsequent releases, the new Vault Safety Help site is the official site for all Vault Safety Help content. This site reflects updates until the 23R3 release only. For the latest information, visit the new site.

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.

This feature is available in vaults deployed in 21R3 (December 2021) or later by default. For vaults deployed before 21R3, an administrator must perform the configuration described on this page.

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

• Manage Product Datasheets: Expectedness in Aggregate Reports
• 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 Page Layouts tab, edit the Aggregate Report Detail Page Layout (aggregate_report_detail_page_layout__c) to add the following fields:
   • Indicate Unexpected Term
   • Datasheet

   

   Updated Aggregate Report Layout

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 Page 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 Page Layout for Datasheets

1. In the Admin area, go to Configuration > Objects > Datasheet.
2. From the Page 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

Updated Datasheet Layout

(Optional) Update the Page 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 Page 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.

Note You do not need to add the Active Date End field to the layout unless approved terms must be unlisted from datasheets at a later date.

MedDRA Criteria Layout

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.

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