Add a designated medical event

For interactive signal configurations, you can maintain a list of designated medical events (DMEs). A DME is an adverse event that your organization wants to monitor closely. DMEs are not associated with particular products.

Before you begin, consider the following:

• 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 designated medical events (DMEs) 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 DMEs using preferred terms.
• You cannot add or delete DMEs while a signal configuration refresh is in progress.
• You can add a maximum of 2000 values as DMEs.
• You must refresh the signal configuration for your changes to take effect.
• You must have the Manage Signaling Terms permission to manage DMEs.

1. In the left navigation pane, click the Signal Review icon ().
2. From the Manage Reference Data menu (), on the top right, click Manage Designated Medical Events.
3. Specify the DMEs to add using one of the following methods:
   • Select <hierarchy> terms.
   • Select available values.
   • Select a saved list of terms.
   • Type the terms.

   Note:

   To prevent spelling and capitalization errors, we recommend that you select rather than type values
4. (Optional) Select the Validate list when saving checkbox.

   If you select the checkbox, Oracle Empirica Signal checks whether the terms that you specified are in the source data. If the terms are not in the source data, an error message appears and the invalid terms are moved to the end of the list.

5. Click Save.
   • The DMEs are saved and are applied when you refresh the signal configuration.
   • In the Product-Event Combinations page, the DME column identifies product-event combinations that are associated with a DME.