With the 25R3 release, users can run Signal Calculations, create Statistical Data, and run signal alerts on FAERS data. After you have configured this feature, see the following resources for next steps:
Update Health Authority Labels
Update the following health authority labels:
- Health Authority Database object
- Health Authority Database object lifecycle
- Health Authority record of the Signal Source object
Update the Health Authority Database Object Label
To update the Health Authority Database object:
- Navigate to Admin > Configuration > Objects > Health Authority Database.
- Select Edit.
- Update the Object Label field to
Signal Source Data
. - Select Save.
Update the Health Authority Database Object Lifecycle Label
To update the Health Authority Database Lifecycle object lifecycle label:
- Navigate to Admin > Configuration > Object Lifecycle > Health Authority Database Lifecycle.
- Select Edit.
- 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:
- Navigate to Business Admin > Objects > Signal Sources > Health Authority.
- Select Edit.
- 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 (![]() |
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:
- 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
- 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:
- Insert the Signal Product Identifier related object section.
- 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:
- Add the following fields to the Details section:
- Signal Source
- Health Authority Database
- Navigate to the Fields tab and select Display in default lists and hovercards for the above fields.
Copy Standard Safety Views
Navigate to Business Admin > Objects > Workbench Views and use the table below to copy standard safety views so you can customize them according to your business needs:
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.
Next Steps: Configure Views & Default Workbench Dashboard
To analyze your FAERS data in Workbench Reports and Workbench Dashboards:
- Configure a Principal View that queries FAERS data. You can use the provided standard FAERS views for reference. Ensure the Data Source is set to FAERS.
- Configure Signal Views as needed for analysis. Ensure the Data Source is set to FAERS.
- Enable Case series on the FAERS Principal View.
- Create a Workbench Dashboard for FAERS.
- In Business Admin > Objects, set the Default Workbench Dashboard to the created FAERS dashboard for the following records:
- Signal Source Data > FDA - FAERS
- Signal Product Profile > [FAERS Signal Product Profile]
Note: To use Workbench Reports and Workbench Dashboards, you must obtain a Veeva Safety Workbench license.