Enable Calculations and Statistical Data Creation for FAERS

With the 25R3 release, users can run Signal Calculations, create Statistical Data, and run signal alerts on FDA Adverse Event Reporting System (FAERS) data. After you have configured this feature, see the following resources for next steps: 

26R3 Update: Include Additional FAERS Data

With the 26R3 release, Veeva supports ingesting additional FAERS data from the FDA. See (26R3) Configure Including Additional FAERS Data to configure your Vault for the updated feature.

Update Health Authority Labels 

Update the following health authority labels: 

Update the Health Authority Database Object Label

To update the Health Authority Database object:

  1. Navigate to Admin > Configuration > Objects > Health Authority Database.
  2. Select Edit. 
  3. Update the Object Label field to Signal Source Data.
  4. Select Save.

Update the Health Authority Database Object Lifecycle Label

To update the Health Authority Database Lifecycle object lifecycle label:

  1. Navigate to Admin > Configuration > Object Lifecycle > Health Authority Database Lifecycle. 
  2. Select Edit. 
  3. Update the Label field to Signal Source Data Lifecycle.

Update the Health Authority Record Name

To update the Signal Source object Health Authority record name: 

  1. Navigate to Business Admin > Objects > Signal Sources > Health Authority.
  2. Select Edit.
  3. Update the Name to Regulatory Database.

Update Signal Source Object Records

Activate and update fields on signal source object records. 

Activate Object Records

In Business Admin > Objects, set the following object records to the Active lifecycle state:

  • Signal Sources > Regulatory Database
  • Signal Source Data > FDA - FAERS
  • Signal Source Data > EMA - EVDAS eRMR

Update the Signal Source and Agency on Object Records

In Business Admin > Objects > Signal Source Data, update the Signal Source and Agency fields for the following object records:

Object Record Signal Source Agency Default Workbench Dashboard
FDA - FAERS Regulatory Database FDA Select a Workbench Dashboard from the drop-down or select the Advanced Search (binoculars-icon) icon to use filters and refine your search.
EMA - EVDAS eRMR Regulatory Database EMA This field applies to the FAERS data source only.

Update Object Layouts

Add the Data Source field to the appropriate layouts and then update the following object layouts:

Add the Data Source Field to Object Layouts

To add the Data Source field to the required layouts:

  1. Add the Data Source field to the Details section of the following object layouts: 
    • Workbench View > Workbench View Detail Page Layout
    • Signal Calculation > Signal Calculation Detail Page Layout
  2. On the Signal Calculations Setting object layout, edit the default columns for the Signal Calculations section to include Data Source. 

Update the Signal Product Profile Layout

To update the Signal Product Profile object layout: 

  1. Insert the Signal Product Identifier related object section.
  2. In the Signal Product Identifier section, edit the default columns to include:
    • Data Source
    • Identifier Type
    • Identifier Value

Update the Signal Product Identifier Layout

To update the Signal Product Identifier object layout, add the following fields to the Details section:

  • Signal Product Profile
  • Data Source
  • Identifier Type
  • Identifier Value

Update the Statistical Data Layout

To update the Statistical Data object layout:

  1. Add the following fields to the Details section:
    • Signal Source
    • Health Authority Database
  2. Navigate to the Fields tab and select Display in default lists and hovercards for the above fields.

Update Data Source VQL on Workbench View Object

To update the criteria VQL for the Data Source field on the Workbench View object, follow the steps in Enable Calculations and Statistical Data Creation for VAERS.

Copy & Update FAERS Views

To copy and update FAERS safety views:

  1. Navigate to Business Admin > Objects > Workbench Views. 
  2. Use the table below to copy FAERS safety views so you can customize them according to your business needs. 
  3. On each custom FAERS view, ensure the Data Source field is set to FAERS and update dependent views and SQL as needed.
Safety View API Name
Sample_FAERS – All Product-Event Combinations Principal sample_faers_all_pec_principal__c
Sample_FAERS Interval Filter View sample_faers_fv_interval__c
Sample_FAERS Cumulative Filter View sample_faers_fv_cumulative__c
Sample_FAERS New Counts sample_faers_new_counts__c
Sample_FAERS Cumulative Counts sample_faers_cumulative_counts__c
Sample_FAERS EBGM - Age Group, Gender, Receipt Year Strata sample_faers_ebgm_ag_sex_ryr__c
Sample_FAERS Case Series - New Counts sample_faers_case_series_new_counts__c
Sample_FAERS Case Series - Cumulative Counts sample_faers_case_series_cumulative_counts__c

Grant Permissions

Ensure your permission sets are updated to grant the appropriate level of access for Admins and users to objects, fields, and tabs according to your organization’s process. Manage permissions from Admin > Users & Groups > Permission Sets > [Permission Set].

Update the relevant permission set to grant Read, Create, Edit, and Delete permissions for the Signal Product Identifier object. 

Configure Views & Default Workbench Dashboard

To analyze your FAERS data in Workbench Reports and Workbench Dashboards:

  1. Configure a Principal View that queries FAERS data. You can use the provided FAERS views for reference. Ensure the Data Source is set to FAERS.
  2. Configure Signal Views as needed for analysis. Ensure the Data Source is set to FAERS.
  3. Enable Case series on the FAERS Principal View.
  4. Create a Workbench Dashboard for FAERS.
  5. In Business Admin > Objects, set the Default Workbench Dashboard to the created FAERS dashboard for the following object records:
    • Signal Source Data > FDA - FAERS
    • Signal Product Profile > [FAERS Signal Product Profile] 

(26R3) Configure Including Additional FAERS Data

To run Signal Calculations and create Statistical Data records for the additional data ingested from FAERS, update the SQL in the appropriate safety views as follows: 

  • For the appropriate FAERS safety view with a default Workbench Dashboard, update the SQL to include the additional FAERS fields. This ensures that Vault considers these fields when returning cases.
  • In the Sample_FAERS – All Product-Event Combinations Principal view, update the SQL to replace the age_in_years and computed_patient_age_group_e2b_code CASE statements with the corresponding derived fields as follows: 
    age_in_years_derived__v AS age_in_years, patient_age_group_e2b_code_derived__v AS computed_patient_age_group_e2b_code

    The patient’s age in years (age_in_years_derived__v) and age group E2B code (patient_age_group_e2b_code_derived__v) are calculated at the time of data ingestion from FAERS.