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

Before performing the configuration on this page, you must first configure the appropriate layouts and permissions.

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 following information:
    • Profile Name: Enter a name for the Signal Product Profile.
    • Product Family: Select a Product Family 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 (binoculars-icon) 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.

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. 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 (for example, FAERS) from the drop-down or select the Advanced Search (binoculars-icon) icon to use filters and refine your search.
    • Identifier Type: Select an Identifier Type from the drop-down. The options include FAERS product brand names, generic names, or substance names. 
    • Identifier Value: Depending on the Identifier Type, enter the brand, generic, or substance name of the product. This value corresponds to the product’s brand, generic, and substance name, respectively, to be searched in the FAERS database.
  4. Select Save or Save + Create to save this record and create another.

Signal Reporting Periods

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