Configure Safety Views for Signal Case Series

Learn how to configure safety views to use Signal Case Series.

About Safety Views for Signal Case Series

You can create safety views of the Signal View type to use Signal Case Series. A Signal Case Series is a static list of Case versions that does not change over time and can be used for consistent signal detection and analysis.

After following the configuration on this page, configure Signal Calculations and Signal Product Profiles for Case series.

Prerequisites

Before you can create Signal Case Series-enabled views, you must enable Signal Case Series.

Create Signal Case Series Views

Create Signal Case Series views to obtain the following data:

  • New Case counts
  • Cumulative Case counts
  • Cases with adverse events evaluated as listed or unlisted

To create a Signal View to use Signal Case Series:

  1. Navigate to Business Admin > Objects > Workbench Views.
  2. Select Create.
  3. In the Create Workbench View dialog, select Signal View and then select Continue.
  4. Complete the details and SQL information about the respective Signal View using the following table and then select Save:
Signal View Name API Name Description SQL
Signal Case Series - New Counts PV Case Series - New Counts Enter a unique name for this view, for example, signal_case_series_new_counts__c. Case Series for Product-Event Combinations from the PV Product Family-Event New Counts View SELECT
filter.case_version_id, filter.product_family_id, filter.pt_code, TRUE AS is_all, filter.is_fatal, filter.is_serious, filter.is_postmarket_spontaneous
FROM
${pv_filterview_interval_pec_for_product__c} filter
Signal Case Series - Cumulative Counts PV Case Series - Cumulative Counts Enter a unique name for this view, for example, signal_case_series_cumulative_counts__c. Case Series for Product-Event Combinations from the PV Product Family-Event Cumulative Counts View SELECT
filter.case_version_id, filter.product_family_id, filter.pt_code, TRUE AS is_all, filter.is_fatal, filter.is_serious, filter.is_postmarket_spontaneous
FROM
${pv_filterview_cumulative_pec_for_product__c} filter
Signal Case Series - Listed PV Case Series - Listed Enter a unique name for this view, for example, signal_case_series_listed__c. Case Series for Product-Event Combinations from the PV Product Family-Event Listed View SELECT
filter.case_version_id, filter.product_family_id, filter.pt_code, TRUE AS filter.is_listed
FROM
${pv_filterview_interval_pec_for_product__c} filter

Vault sets the Signal Case Series Enabled checkbox after you configure the View Columns section for the Signal Case Series. Follow the steps in the sections below to add dependent views and view columns.

Add Dependent Views

When creating a new Signal View, this section appears only after saving.

To add a dependent view, expand the Dependent Views section and select Create. Use the following table to add the respective dependent view:

Signal View Dependent View
Signal Case Series - New Counts The dependent view should match that of the corresponding Case count view, for example, PV Filter View - Interval Product-Events for a Product Family.
Signal Case Series - Cumulative Counts The dependent view should match that of the corresponding Case count view, for example, PV Filter View - Cumulative Product-Events for a Product Family.
Signal Case Series - Listed The dependent view should match that of the corresponding Case count view, for example, PV Filter View - Interval Product-Events for a Product Family.

Add View Columns

When creating a new Signal View, this section appears only after saving.

To populate the View Columns section:

  1. In the View Columns section, select Create.
  2. Complete the following fields in the Create Workbench View Column dialog:
    • Name: Enter the Name of the view column.
    • API Name: Enter the API Name of the view column. This value must match the name of the column returned by the SQL query.
    • Column Type: Select a field type option from the drop-down.
    • Optional: Picklist: If you selected the Picklist column type, select a picklist option from the drop-down.
    • Optional: Safety Object Reference: The Safety Object Reference and Safety Object Constraint fields allow you to restrict the values that appear when filtering on this object, for example, restricting the Controlled Vocabulary object to display only Drug Roles. Enter the API name of the object associated with this view column field.
    • Optional: Safety Object Constraint: The Safety Object Reference and Safety Object Constraint fields allow you to restrict the values that appear when filtering on this object, for example, restricting the Controlled Vocabulary object to display only Drug Roles. Enter VQL to configure a reference constraint to restrict the object values.
    • Signal Case Series Key: For all view columns except Case Version ID, enter a Signal Case Series Key. The Signal Case Series Key must match the API name of the Statistical Data field. This field ensures Vault maps the correct data from the Signal Case Series view when users create a Statistical Data record.
    • Case Version Key: For the Case Version ID view column, select Yes.
      When you populate the Signal Case Series Key for all view columns and assign the Case Version ID view column as the Case Version Key, Vault automatically sets the Signal Case Series Enabled checkbox.
  3. Select Save.
  4. Repeat the steps above to add additional columns.
  5. Optional: To delete a field, select the Actions menu next to the field and then select Delete.

Assign the Case Version Key on Principal Views

For Vault to execute your configured Signal Views using Signal Case Series, for each associated Principal View, you must assign the Case Version Key to the Case Version ID view column.