Configure Safety Views in Safety Signal

Learn how to configure safety views for signal detection.

About Safety Views

Use safety views to define the SQL and filters, which Vault references when running calculations to detect Product-Event Combinations (PECs) for pharmacovigilance (PV) data.

Safety Signal includes the following safety views:

• Principal Views: Contain the largest collection of data and preconfigured parameters. For example, a Principal View might include data for all post-market Cases with the Drug product type. Vault derives all Filter Views and Signal Views from a Principal View. Principal Views are important as some statistical methods and calculations require a complete dataset.

• Filter Views: Contain a subset of data from a specified Principal View and filters. For example, a Filter View might filter on a Product Family with a given start date. Vault derives a Filter View from a Principal View. Filter Views offer more specific analyses and can detect adverse events within a Product Family from a given period.

• Signal Views: Contain the most specific subset of data in the view hierarchy. For example, a Signal View might return Case counts for all pediatrics in this quarter. Vault derives a Signal View from a Principal View and a Filter View.

The sections in this article describe the different sections of a safety view and how to complete them.

Create and Access Safety Views

To access a safety view, navigate to Business Admin > Objects > Workbench Views.

Select Create to create a new view. In the Create Workbench View window, specify the type of view you want to create and then select Continue.

Dependent Views

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

Signal Views and Filter Views are always dependent on another safety view, meaning they derive their data and configuration parameters from the specified safety view. The safety view on which the Signal or Filter View is dependent is known as a dependent view. A Signal View is usually dependent on a Principal View, a Filter View, or both. A Signal View can also be dependent on other Signal Views and multiple Filter Views. A Filter View is always dependent on a Principal View.

Principal Views are the basis for Filter and Signal Views to add filters and configuration and, therefore, are not dependent on any views.

The following illustration demonstrates an example of a safety view hierarchy. The hierarchy always starts with a Principal View. In this example, a Principal View leads into two (2) Filter Views. Each Filter View subsequently leads into two (2) Signal Views.

Although a Signal View may not always include a Principal View in the Dependent Views section, a Signal View must ultimately be associated with one (1) unique Principal View through other dependent views. In the above example, Signal Views A.1 and A.2 are not directly associated with the Principal View but are associated with it through Filter View A. If a safety view is not associated with any or is associated with more than one (1) Principal View, Vault prevents you from adding filters to the safety view.

Create a Dependent View

To add a dependent view to a safety view:

1. In the Dependent Views section of the safety view, select Create.
2. In the Create Workbench View Dependency window, select a dependent view.
3. Select Save or Save + Create to add another dependent view.

Result

Vault adds the selected views to the Dependent Views section and generates a name for each.

The current view is now dependent on these selected safety views.

SQL Editor

SQL offers elaborate queries for parsing through data.

Your Veeva Representative provides and inputs the queries in the SQL Editor section in your Vault. The queries are based on Amazon Redshift SQL, which is a subset of PostgreSQL 9.x. For more information on the available SQL functions, refer to Amazon Redshift and PostgreSQL.

Only Principal Views and Signal Views contain SQL. When previewing a Filter View, this view inherits queries from the associated Principal View.

The SQL query provides references for the fields specified in the safety view’s View Columns section. You cannot run a preview of the safety view unless the View Columns are populated according to the SQL.

The safety view can also access parameters of another safety view by referencing the safety view’s API name in the SQL Editor section. For example, select * from ${safety_view_api_name__c}. You must also create a dependent view for the safety view you are referencing.

Limitations

The following lists the safety view SQL limitations:

• Vault does not perform any validation checks when inputting or saving the SQL. Issues are identified through a server error after running the preview.
• Vault does not perform timeout checks when running SQL. Long-running queries will be terminated by Amazon Redshift. Related performance issues are identified through logged server errors.

View Columns

When creating a new safety view, this section appears only after saving.

The fields you add to a safety view’s View Columns section determine the fields to which you can apply filters. The View Columns section is usually populated in the Principal View to inform the filters in the subsequent Filter Views.

The View Columns are required for the safety view’s SQL to run successfully.

Supported field types include:

• Picklist
• Object
• Text
• Date and DateTime
• Number
• Yes/No

Create View Columns

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 window:
   • 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.
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.

Filters

You can configure filters in the Filters section of the safety view. Filters you add to the safety view also appear on associated Signal Calculation Run records.

You can only add safety view filters if the View Columns section is populated. This section can be populated on the current safety view or on the associated Principal View.

For more information, see Add Safety View Filters in Safety Signal.

Run Preview

You can generate a preview of the safety view by selecting Run in the Run Preview section.

After you run the preview, Vault executes the SQL for this safety view and returns a list of up to 100 records. The output is displayed in a table format based on the view columns’s Column Type. Optionally, you can select the column header to sort the records returned by the run.

If the SQL is invalid, the run times out after 60 seconds and Vault returns a server error.