Maintain a list of targeted medical events

For interactive and multisource configurations, you can maintain a list of targeted medical events (TMEs) for each product. A TME is an adverse event that your organization wants to monitor closely for a particular product. For example, you might add Hepatic failure as a TME for Product A.

Before you begin

• You must have the Manage Signaling Terms permission to manage TMEs.
• The Data Configuration for 2D Runs specified for the signal configuration must be present and valid.
• The Event Variable for 2D Runs and Drug Variable for 2D Runs specified for the signal configuration must exist in the Data Configuration for 2D Runs.
• You define TMEs at the hierarchy level specified in the Event Variable for 2D Runs field for the signal configuration. For example, if the Event Variable for 2D Runs is (Event) PT, you define TMEs using preferred terms.
• You cannot add or delete a targeted medical event while a signal configuration refresh is in progress.
• You must refresh the signal configuration for your changes to take effect.

If you are working from a multisource signal configuration:

• TMEs are shared between the multisource signal configuration and the lead configuration, as well as any other connected configuration. Modifications made in one configuration will be saved to all.
• You cannot add or delete TMEs in a multisource signal configuration if the lead configuration or any connected configuration is undergoing a refresh.

1. In the left navigation pane, click the Signal Review icon ().
2. (Optional) From the Products By drop-down list, select a product grouping, then select a card to filter the Products table.
3. Click the product's Row Action menu () and select Manage Targeted Medical Events.
4. Add a TME for the product using one of the following methods:
   • Select < hierarchy > terms.
   • Select available values.
   • Select a saved list of values.
   • Type the values.

   Note:

   To prevent spelling and capitalization errors, we recommend that you select rather than type values.
5. (Optional) Select the Validate list when saving checkbox.
6. Click Save.
   • The TMEs are saved and are applied when you refresh the signal configuration.
   • If you are working with a multisource signal configuration, you must refresh the underlying lead configuration first, then refresh the multisource signal configuration for changes to take effect.
   • In the Product-Event Combinations page, the TME column identifies product-event combinations that are associated with a TME.