Editing a signal configuration

Name

Signal configuration name. When more than one signal configuration is published to a user, this name appears on the Signals tab, above the drug-event combination table. 

Description

Description of the signal configuration.

Default signal view

Name of the signal view that is used when you select the Signals tab, then select Drug-Event Combinations, and select -- from the Drug drop-down list. The application also uses the default signal view as the default view for drugs that do not have a default view selected.

Note: To specify a default view for a drug, on the Drug Overviews page, click for a drug, and then click Edit.

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 drug-event combinations using the Document Review dialog box, and topics are stored in this topic workflow configuration.

Note: If drug-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.

Topic Product Field

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

Disable default view

Select to disable the default view on the Drug-Event Combinations page.

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 drug-event combinations.

Data configuration for all reports*

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

Browse for a configuration or select one from the drop-down list.

Data configuration for 2D runs*

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

Browse for a configuration or select one from the drop-down list.

Data configuration for 3D runs*

Name of the data configuration used to execute three-dimensional data mining runs. Typically, this data configuration includes concomitant drugs.

Browse for a configuration or select one from the drop-down list.

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 Drug-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 drug's reference data*

Select to enable all reviewers of a drug to configure Targeted Medical Events and Listed Events for the drug on the Drug Overviews page.

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