Enable Multi-Source Signal Data Consolidation

With the 26R1 release, users can now create Statistical Data records to store Product-Event Combination (PEC) data from multiple data sources. After you have configured this feature, see Signal Detection Overview for more information.

Configure Custom Fields on Statistical Data Object

On the Statistical Data object, data fields (such as Case counts and EBGM scores) already exist for the Safety database. You must create similar fields on the Statistical Data object to accommodate data from different sources. To do this: 

  1. Navigate to Admin > Configuration > Objects > Statistical Data > Fields. 
  2. Select Create.
  3. From the Field Type drop-down, select Number.
  4. Use the table below to complete the field information for FAERS, and then repeat this configuration for VAERS and eRMR respectively. For the minimum and maximum values, use the corresponding Safety data field for reference, for example, New All FAERS corresponds with New All. Depending on the field, this range may vary.
  5. Refer to the EVDAS eRMR Data object for additional data fields if you want to add them to the Statistical Data object.   
Label Name
New All FAERS new_all_faers__c
New Spontaneous FAERS new_spontaneous_faers__c
New Fatal FAERS new_fatal_faers__c
New Serious FAERS new_serious_faers__c
Cumulative All FAERS cumulative_all_faers__c
Cumulative Spontaneous FAERS cumulative_spontaneous_faers__c
Cumulative Fatal FAERS cumulative_fatal_faers__c
Cumulative Serious FAERS cumulative_serious_faers__c
EBGM FAERS ebgm_faers__c
EB05 FAERS eb05_faers__c
EB95 FAERS eb95_faers__c

Update Object Layouts

To update object layouts:  

  • For the Signal Calculations Setting object layout, add the Results Output field to the Details section.
  • For the Statistical Data object layout, add the Calculation Data Sources field to the Source section and remove the Source and Health Authority Database fields.
  • For all Workbench View object layouts, add the Data Source field to the Details section.

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.

Configure the Open FAERS and VAERS Case Series in Dashboard Actions

To allow users to analyze and visualize FAERS and VAERS Signal Case Series data in Workbench Dashboards, assign the Open FAERS Case Series in Dashboard and the Open VAERS Case Series in Dashboard actions to the Statistical Data object. Then, add the actions as user actions to the applicable states of the Statistical Data Lifecycle object lifecycle.

Grant Permissions

Update the relevant permission sets to grant Execute permission for the following Statistical Data object actions: 

  • Open FAERS Case Series in Workbench Dashboards
  • Open VAERS Case Series in Workbench Dashboards

Configure EVDAS Views

To return EVDAS data in calculations and store them in Statistical Data records, you must create a Signal View (to be referenced in Signal Calculations) and an associated Principal View:

  1. Navigate to Business Admin > Objects > Workbench Views. 
  2. Use the table below to create EVDAS safety views. 
  3. On each custom EVDAS view, ensure the Data Source field is set to EMA - EVDAS eRMR and update dependent views and SQL according to your business needs.
  4. On the EVDAS Principal View, create a view column for the reporting period with the following information: 
    • Name: Enter Reporting Period ID.
    • API Name: Enter reporting_period_id.
    • Column Type: Select Object.
    • Safety Object Reference: Enter evdas_ermr_data__v.
  5. Create view columns for additional fields according to your business needs.
Safety View Type Name API Name
Principal View EVDAS eRMR - All Product-Event Combinations Principal evdas_ermr_all_product_event_combinations_principal__c
Signal View EVDAS eRMR - Product-Event Combinations evdas_ermr_product_event_combinations__c

The Principal View returns all relevant fields from the EVDAS eRMR Data object for a Signal Reporting Period ID. The Signal View returns the final results, including Product Family ID or Aggregate Reporting Group ID and MedDRA code.

Next Steps: Configure and Assign Default Workbench Dashboard

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

  1. Create a Workbench Dashboard for EVDAS.
  2. Navigate to Business Admin > Objects > Signal Data Source > EMA - EVDAS eRMR. 
  3. Set the Default Workbench Dashboard to the created EVDAS dashboard.
  4. Navigate to Business Admin > Objects > Workbench Views and select the EVDAS safety view being used in the EVDAS dashboard. 
  5. To ensure reporting period, product, and event data will be captured in the EVDAS dashboard, create required filters for the following fields: 
    • Reporting Period ID (the API name must be reporting_period_id)
    • Product Family or Aggregate Reporting Group
    • MedDRA Code

Configure and assign a default Workbench Dashboard for FAERS and VAERS, if one has not been configured already.