Edit a signal configuration

You can edit signal configurations if you have the Manage Signal Configurations permission.
  1. In the left navigation pane, click the Settings icon (Settings icon).
  2. In the Configure System section, click Manage Signal Configurations.
  3. Click the Row Action menu (Row Action menu icon) for the signal configuration, and then click Edit.

    If the signal configuration Type is Interactive, an Interactive Signal Configuration Properties section appears in the Edit Signal Configuration page.

  4. Edit the fields according to the table below.
  5. Click Save.

    Oracle Empirica Signal validates the signal configuration, and any errors are displayed at the top of the page.

Field descriptionsEdit Signal Configuration page
Fields marked with an asterisk (*) in the table are available only for interactive signal configurations.
Field Description

Name

Signal configuration name. This name appears on the Signal Review page, above the product-event combination table.

Description

Description of the signal configuration.

Topic workflow configuration

Name of the topic workflow configuration that is integrated with the signal management configuration. When this integration exists, users can associate topics with product-event combinations using the Submit Review dialog box, and topics are stored in this topic workflow configuration.

Note:

If product-event combinations have associated topics, you cannot change the associated topic workflow configuration until you remove the associated topics. The Signal History maintains a log of all changes.

Note:

If you do change the integrated topic workflow configuration, exit the application and log in to the application again.

Topic Product Field

Names of products in product-event combinations associated with topics. You can use the Topic Product Field filter when browsing for existing topics from the Submit Review dialog box.

Disable review period

Select to disable the Review Period column and Review Period filter on the Manage Signal Views page.

Disable private comment

Select to disable private comments for product-event combinations.

Data configuration for all reports *

Name of the data configuration or an alias used when you perform a data mining run against all safety reports.

Use the drop-down list to select a configuration or alias. Use Browse to select a configuration.

Data configuration for 2D runs *

Name of the data configuration or an alias used to execute two-dimensional data mining runs. Typically, this data configuration excludes reports from studies and literature.

Use the drop-down list to select a configuration or alias. Use Browse to select a configuration.

Data configuration for 3D runs *

Name of the data configuration or an alias used to execute three-dimensional data mining runs. Typically, this data configuration includes concomitant products.

Use the drop-down list to select a configuration or alias. Use Browse to select a configuration.

Drug variable *

Drug Variable used in data mining runs, for example, Product Generic Name or Preferred Product Name.

Event variable for 2D runs *

Event Variable used in two-dimensional data mining runs, for example, PT (Preferred Term) or SMQs (Standardised MedDRA Queries).

Event variable for 3D runs *

Event variable used in three-dimensional data mining runs, for example, PT (Preferred Term). Typically, this variable does not include SMQs due to the size of the data mining results table.

For three-dimensional data mining runs, the Drug variable is also used.

Stratification variables *

Stratification variables used in data mining runs.

Subset variable for signal history *

For data mining runs, subset variable that provides results in the View Signal History page.

Subset variable for Nsince counts *

For data mining runs, subset variable that provides results in the Nsince column on the Product-Event Combinations page.

Project for data mining runs *

Name of the project used to store data mining runs that are part of a refresh.

Publish data mining runs *

Select to publish the data mining runs created when a user refreshes the signal management configuration.

By default, the runs are published to the same login group that the signal configuration is published to. A user can manually publish the data mining runs to additional login groups.

Allow reviewers to manage their product's reference data *

Select to enable all reviewers of a product to configure Targeted Medical Events and Listed Events for the product in the Products table on the Signal Review page.

If deselected, only superusers and reviewers with the Manage Signaling Terms user permission can configure Targeted Medical Events and Listed Events.