Manage Signal Product Profiles

Signal Product Profiles define the signal detection scope. You can specify the Product Family, the database to which the profile has access and the appropriate Signal Alert Rule Sets that determine whether the Product-Event Combination (PEC) is a potential signal.

Prerequisites

Consider the following prerequisites:

• To use Signal Product Profiles, you must first configure the appropriate layouts and permissions.
• To create Signal Product Profiles at the Aggregate Reporting Group level:
  • Enable Signal Calculations for Product Family Combinations
  • Configure Signal Calculations Settings for Aggregate Reporting Groups
• To support scheduled Signal Reporting Period creation for Signal Product Profiles on a schedule, enable Signal Review Scheduling.
• To support scheduled signal detection, you must enable Scheduling Signal Calculations & Alerts.
  • To define default Calculation Criteria on Signal Product Profiles, you must configure the relevant section on the layout and then add Workbench View Parameters (for example, MedDRA Query ID and/or Subgroup) on the safety views associated with the Signal Calculations Setting.

Create Signal Product Profiles

To create a Signal Product Profile:

1. Navigate to Business Admin > Objects > Signal Product Profiles.
2. Select Create.
3. Complete the applicable fields:
   • Profile Name: Enter a name for the Signal Product Profile.
   • Signal Detection Plan: To define the signal detection methodology for the Product Family or Aggregate Reporting Period, select a Signal Detection Plan from the drop-down or select the Advanced Search () icon to use filters and refine your search. Alternatively, you can create a Signal Product Profile directly on a Signal Detection Plan.
   • Product Family: Select a Product Family from the drop-down or select the Advanced Search icon to use filters and refine your search.
   • Aggregate Reporting Group: Select an Aggregate Reporting Group from the drop-down or select the Advanced Search icon to use filters and refine your search.
   • Source: Select a Source from the drop-down or select the Advanced Search icon to use filters and refine your search.
   • Calculations Setting: Select a Calculations Setting from the drop-down or select the Advanced Search icon to use filters and refine your search.
   • Default Workbench Dashboard: This field references a Workbench Dashboard that is enabled for Signal Case Series. Select a Workbench Dashboard from the drop-down or select the Advanced Search icon to use filters and refine your search.
   • Organization: Select an Organization from the drop-down or select the Advanced Search icon to use filters and refine your search.
4. Select Save or Save + Create to save the Signal Product Profile and create another.

After saving the record, the sections below appear. Follow the steps in the sections to complete the Signal Product Profile depending on your business needs.

Calculation Criteria

You can define the default values for MedDRA Queries and/or Signal Subgroups directly on the Signal Product Profile for Signal Calculation runs. For bulk manual and scheduled Signal Calculation runs, Vault looks at the Calculation Criteria on the Signal Product Profile, if available, to specify parameters for the Signal Calculations.

To create a Calculation Criteria record: 

1. In the respective Signal Product Profile, expand the Calculation Criteria section.
2. Select Create. 
3. In the Create Calculation Criteria dialog, select a value for the available parameters (for example, MedDRA Query only, Subgroup only, or MedDRA Query and Subgroup). The parameter fields that appear on the Calculation Criteria record depend on the Workbench View Parameters on the safety views associated with the Signal Calculations Setting. 
   For each available parameter field and field combination, Vault displays a Calculation Criteria card; for example, for MedDRA Query only criteria, Subgroup only criteria, and MedDRA Query and Subgroup combination criteria.
4. Select Save. 
5. Select + Row at the bottom of the respective Calculation Criteria card to define additional parameter values for the Signal Product Profile.

Calculation Criteria must be unique in that only a single record can exist for any single parameter field or parameter field combination. For example, if a Calculation Criteria with a MedDRA Query value of Arthritis and Subgroup value of Age Group already exists, you cannot create another Calculation Criteria record with these parameter values.

Schedule

This section is for scheduled Signal Reporting Period creation and indicates the following:

• Schedule: This field is required for scheduled reporting period creation. To define the cadence of creation and review, select a Schedule from the drop-down or select the Advanced Search icon to use filters and refine your search.
• Schedule Start Date: This field is required for scheduled reporting period creation. To define the start date on which Vault runs the scheduled reporting period creation, use the calendar to select the Schedule Start Date or enter the date manually.
• Schedule Initiated By: Vault populates the user who ran the Schedule Signal Review action and updates this field each time the action is initiated.
• Schedule Initiated Date/Time: Vault populates the date and time of the Schedule Signal Review action initiation and updates this field each time the action is initiated.
• Schedule Terminated Date/Time: Vault populates the date and time of the scheduled signal review cancellation.

Alert Rule Sets

Signal alerts determine whether a PEC qualifies as a potential signal. To add Signal Alert Rule Sets to the Signal Product Profile:

1. In the respective Signal Product Profile, expand the Alert Rule Sets section.
2. Select Add.
3. In the Signal Alert Rule Set dialog, select the applicable Signal Alert Rule Sets or select Create to create new ones. You can also use the search bar and filters to refine your search.
4. Select OK.

To learn about how signal alerts work, see Run & Review Signal Alerts.

Signal Product Identifiers

Vault uses Signal Product Identifiers to map products from external databases (for example, FAERS) to safety views referenced in Signal Calculations. Vault looks at the Signal Product Identifiers and returns the Cases meeting those specifications. To add Signal Product Identifiers to a Signal Product Profile:

1. In the Signal Product Profile, expand the Signal Product Identifier section.
2. Select Create.
3. In the Complete Signal Product Identifier dialog, complete the following information: 
   • Data Source: Select a Data Source from the drop-down or select the Advanced Search icon to use filters and refine your search.
   • Identifier Type: Select an Identifier Type from the drop-down.
   • Identifier Value: Depending on the Identifier Type, enter the respective value for which Vault will search in the source’s database. For example, if you select faers_product_brand_name__brand_name as the Identifier Type, enter the brand name of the product.
4. Select Save or Save + Create to save this record and create another.

If Signal Product Identifiers with the same Identifier Type exist for the Signal Product Profile, Vault looks for Cases that match at least one corresponding Identifier Value. For example, if the product profile includes multiple identifiers of the faers_product_brand_name__brand_name type, Vault returns FAERS cases matching on one of the specified product brand names. If there are product identifiers with different Identifier Types, Vault looks for cases that match on all the Identifier Values. For example, if the product profile includes an identifier of the vaers_product__vaccine_name type and an identifier of the vaers_product__manufacturer type, Vault returns VAERS cases matching on both the vaccine name and the manufacturer.

Signal Reporting Periods

This section includes the created Signal Reporting Periods for this Signal Product Profile.