Oracle Health Sciences Empirica Signal

Quick Start for Interactive Signal Management Configuration

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Set up or update an Interactive Signal Management (ISM) configuration

Oracle Empirica Signal offers an analysis environment for exploring post-marketing safety data. The source data may be public, such as the data in the FDA Adverse Event Reporting System (AERS) and Vigibase, or your organization's proprietary Oracle Argus product-safety database.

Prerequisites:

For new cloud implementations:

If these activities are not complete, contact Oracle.

An Interactive Signal Management configuration is available:

If these activities are not complete, contact Oracle.

If you are performing a periodic update of your Interactive Signal Management configuration, start with Step 2.

You can adjust the settings as needed.

  1. In the left navigation pane, click the Settings icon ().
  2. In the Configure System section, click Manage Signal Configurations.
  3. Select the Interactive Signal Management configuration, click the configuration's Row Action menu (), and then click Edit.
  4. If you also use the Oracle Empirica Signal Topic Management feature and would like to associate this signal configuration with a topic workflow configuration, select values for Topic workflow configuration and Topic product field.
  5. Accept or modify the default values on the page. Except for fields mentioned in Step 4, the defaults are appropriate for most organizations.

A custom term is a pseudo-value that is added in data mining to split terms into more specific sub-items, or group together similar terms for products or events. Use custom terms to better identify your own products in public data sets; for example, the generic name may be too broad and you want to add criteria such as indication or route of administration, or implement Company/Custom MedDRA Queries (CMQs).
Tip: Create all of your custom terms before proceeding so they are available when you add Designated Medical Events (DMEs) and products.

To add custom terms:

  1. In the left navigation pane, click the Signal Review icon ().
  2. If necessary, select the signal configuration from the Signal Review drop-down list.
  3. From the Manage Reference Data menu () on the top right, click Manage Custom Terms.
  4. On the top left, click Create Custom Term.
  5. In the Name field, enter a name for the custom term. Oracle Empirica Signal automatically appends "Custom Term" to the name when it displays the product.
  6. From the Item variable drop-down list, choose Drug or Event.
  7. Click Create Using Query Wizard to create a query for the custom term.
  8. Follow the Query Wizard's instructions, beginning on the Define Query page, then return to the Create Custom Term page.
  9. (Optional) Click the Hierarchy Path link, select a value, and then click OK.
  10. Click OK.

The custom terms are saved and are applied when you refresh the signal configuration.

A custom term is a pseudo-value that is added in data mining to split terms into more specific sub-items, or group together similar terms for products or events. Use custom terms to better identify your own products in public data sets; for example, the generic name may be too broad and you want to add criteria such as indication or route of administration, or implement Company/Custom MedDRA Queries (CMQs).
Tip: Create all of your custom terms before proceeding so they are available when you add Designated Medical Events (DMEs) and products.

To edit custom terms:

  1. In the left navigation pane, click the Signal Review icon ().
  2. If necessary, select the signal configuration from the Signal Review drop-down list.
  3. From the Manage Reference Data menu (), on the top right, click Manage Custom Terms.
  4. To change a custom term, select the custom term's Row Action menu (), then click Edit.
  5. Edit the fields as necessary.
  6. Click OK.

A designated medical event (DME) is an adverse event that your organization wants to monitor closely. DMEs are not associated with particular products.

  1. In the left navigation pane, click the Signal Review icon ().
  2. If necessary, select the signal configuration from the Signal Review drop-down list.
  3. From the Manage Reference Data menu () on the top right, click Manage Designated Medical Events.
  4. Add or edit events by selecting terms from the MedDRA hierarchy browser, from a list of values available in the data (including event Custom Terms), or from a saved list.
  5. Click Save.
    The DMEs are saved and are applied when you refresh the signal configuration.

Your organization chooses the products to monitor.

  1. In the left navigation pane, click the Signal Review icon ().
  2. If necessary, select the signal configuration from the Signal Review drop-down list.
  3. From the Manage Reference Data menu (), in the upper right corner, select Add Product.
  4. To add a product, click the Select Available Value link to choose a product from those available for this Signal Configuration. Custom terms you created also appear with "Custom Term" appended to the term.
  5. Click OK.
  6. On the Add/Edit Product page, specify properties for the product. Product properties, such as Review Period, Complexity level, and Birthdate, can be used in alert calculations. Other product properties, such as Category, Organization, Product group, and Reviewers, are used to organize products into categories on the Signal Review page.
  7. Click Save.
  8. Repeat these steps for each product you want to monitor.

A TME is an adverse event that you want to monitor closely for a particular product.

  1. In the left navigation pane, click the Signal Review icon ().
  2. If necessary, select the signal configuration from the Signal Review drop-down list.
  3. Click the product's Row Action menu () and select Manage Targeted Medical Events.
  4. Click Select MedDRA Terms, Select Available Values, or Select Saved List.
  5. Add or edit events by selecting terms from the MedDRA hierarchy browser, from a list of values available in the data (including event Custom Terms), or from a saved list.
  6. Click OK.
  7. Click Save.
    The TMEs are saved and are applied when you refresh the signal configuration.

A listed event is an adverse event that is listed on the product label.

  1. In the left navigation pane, click the Signal Review icon ().
  2. If necessary, select the signal configuration from the Signal Review drop-down list.
  3. Click the product's Row Action menu () and select Manage Listed Events.
  4. Add or edit events by selecting terms from the MedDRA hierarchy browser, from a list of values available in the data (including event Custom Terms), or from a saved list.
  5. Add or edit a listed event for the product by adding values to or deleting values from the Selected Values list.
  6. Click OK.
  7. Click Save.
    The listed events are saved and are applied when you refresh the signal configuration.

After a refresh, alerts are raised on product-event combinations based on rules configured in the alert type definitions. Total alert counts for products and product-event combinations are displayed in the tables and graphs provided on the Signal Review pages. There are two types of alerts:

  • Tracked: Alerts for which product-event combinations require an initial signal review in the current period. Oracle Empirica Signal monitors the review progress of tracked alerts with Reviewed/Total counts.
  • Informational: Alerts for which product-event combinations do not require review. For these alerts, Oracle Empirica Signal provides a Total count.

Although alert types are configurable, the default alert types, or those defined in your migrated scripted signal configuration, may suit your needs. Review these before modifying existing or adding new alert types.

  1. In the left navigation pane, click the Settings icon ().
  2. From the Configure System menu, select Manage Signal Configurations.
  3. Click the configuration's Row Action menu (), then click Edit Alert Types. Review the alert types shown.
    We recommend that you run a refresh and review the alert results before changing or adding alert types.

The result of a successful refresh includes updates to the Products table and Product-Event Combinations table on the Signal Review page. During a refresh, Oracle Empirica Signal incorporates any changes made so far and validates the signal configuration.

Tip: To double check the changes made, follow steps 1 and 2, below, click the Manage Refreshes link, then select View Refresh Details from the configuration's Row Action menu ().

  1. In the left navigation pane, click the Settings icon ().
  2. In the Configure System section, click Manage Signal Configurations.
  3. Click the configuration's Row Action menu (), then click Refresh.
  4. Specify when to perform the refresh:
    • Run as soon as possible—The refresh is executed immediately.
    • Do not run until—The refresh is executed on the date and time that you specify.
  5. To receive an email notification when the refresh is complete:
    1. Select the Email me when complete check box.
    2. Type one or more email addresses using a comma to separate each address.
  6. Click Submit.
  7. Click Continue.

Now that you have refreshed the ISM, you can optionally edit and add, activate, and deactivate alert types. Oracle recommends that you initially keep all alert types as Informational. Follow this process:

  1. Make the alert type edits and additions.
  2. Run a refresh.
  3. Review the impact of the changes.
  4. Repeat as necessary.
  5. Once you are satisfied with the alert type definitions, then edit selected alert types to make them tracked alerts.

Note: The alert type rules are based on a Product-Event Combination view. If you plan on changing an existing alert type's rule or you want to add a new alert type, you need to first create and save the view. When your views are completed, use the Alert Type rule action menu option, *Import from View*, to convert the saved view into an alert type rule.

Edit an alert type

  1. In the left navigation pane, click the Settings icon ().
  2. From the Configure System menu, select Manage Signal Configurations.
  3. Find the configuration, click the configuration's Row Action menu (), then select Edit Alert Types.
  4. To edit an alert type, click the alert's Row Action menu (), then select Edit.
  5. Make your changes.

  6. (Optional) To make an alert type tracked, select the Tracked alert checkbox, provide a one-letter abbreviation, and then select a color to associate with the alert type. The abbreviation and color appear on the Product-Event Combinations table as the tracked alert's icon.

Now that you have refreshed the ISM, you can optionally edit and add, activate, and deactivate alert types. Oracle recommends that you initially keep all alert types as Informational. Follow this process:

  1. Make the alert type edits and additions.
  2. Run a refresh.
  3. Review the impact of the changes.
  4. Repeat as necessary.
  5. Once you are satisfied with the alert type definitions, then edit selected alert types to make them tracked alerts.

Note: The alert type rules are based on a Product-Event Combination view. If you plan on changing an existing alert type's rule or you want to add a new alert type, you need to first create and save the view. When your views are completed, use the Alert Type rule action menu option, *Import from View*, to convert the saved view into an alert type rule.

Add an alert type

Note: Oracle recommends that you create new alert types as Informational, run a refresh, and review results before changing the alert type to tracked.

  1. In the left navigation pane, click the Settings icon ().
  2. From the Configure System menu, select Manage Signal Configurations.
  3. Find the configuration, click the configuration's Row Action menu (), then select Edit Alert Types.
  4. In the top left corner, click Add Alert Type.
  5. Enter values for Label and Description.
  6. Do one of the following:
    1. Select a value for Alert rules based on table.
    2. Import a view and convert it into an alert type rule by selecting Import from View from the view's Row Action menu ().
  7. Click Save.

Now that you have refreshed the ISM, you can optionally edit and add, activate, and deactivate alert types. Oracle recommends that you initially keep all alert types as Informational. Follow this process:

  1. Make the alert type edits and additions.
  2. Run a refresh.
  3. Review the impact of the changes.
  4. Repeat as necessary.
  5. Once you are satisfied with the alert type definitions, then edit selected alert types to make them tracked alerts.

Note: The alert type rules are based on a Product-Event Combination view. If you plan on changing an existing alert type's rule or you want to add a new alert type, you need to first create and save the view. When your views are completed, use the Alert Type rule action menu option, *Import from View*, to convert the saved view into an alert type rule.

Activate or deactivate an alert type

You can designate an alert type to be active or not for the next refresh.

  1. In the left navigation pane, click the Settings icon ().
  2. From the Configure System menu, select Manage Signal Configurations.
  3. Find the configuration, click the configuration's Row Action menu (), then select Edit Alert Types.
  4. Click the alert type's Row Action menu (), then select Activate or Deactivate.
  5. Repeat Step 4 as needed.

Once you are satisfied with the ISM, make it available to login groups and users by publishing it.

Tip: Because the condition of the alert type rule is derived from views, your views must be set up before you can perform these steps. You do this when investigating product-event combinations.

  1. In the left navigation pane, click the Settings icon ().
  2. In the Configure System section, click Manage Signal Configurations.
  3. Select the configuration, click the configuration's Row Action menu (), and then click Publish.
  4. To grant permissions for the configuration to your login group, if you are a superuser, select it from the Publish to Login Groups list.
  5. Click Publish.
Find out more about Oracle Empirica Signal

Get more information

See the Oracle Empirica Signal documentation library on the Oracle Help Center.

Other resources

Watch short training videos on the Oracle Help Center.

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For assistance, contact Health Sciences Cloud Support.

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