Add a designated medical event
You can maintain a list of designated medical events (DMEs) for interactive and multisource configurations. A DME is an adverse event that your organization wants to monitor closely. DMEs are not associated with particular products.
Before you begin
- 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.
If you are working from a multisource signal configuration:
- DMEs are shared between the multisource signal configuration and the lead configuration, as well as any other connected configurations. Modifications made in one configuration will be saved to all.
- You cannot add or delete DMEs in a multisource signal configuration if the lead configuration or any other connected configuration are undergoing a refresh.
Adding a designated medical event
Parent topic: Manage events and custom terms