Manage signal configuration reference data

Just below your user name in the upper right corner of the Products and Product-Event Combinations pages is the Manage Reference Data menu ():

These menu choices apply to the signal configuration and require permissions to specify or change them:

• Add Product: Your organization chooses the products to monitor. For non-interactive signal configurations, Oracle creates the list of monitored products during preparation of the signal management data. You must have the Manage Signaling Terms permission to add to and to edit the product list.
• Auto-Assign to Reviewers: You must have the Manage Signaling Terms permission to automatically assign reviewers to products. You must have the Allow Automatic Assignment of Reviewers permission to auto-assign reviewers.
• Modify Automatic Assignments: There is one reviewer per product. The Modify Automatic Assignments page provides information about products that have been assigned automatically to a reviewer. This page does not show assignments that were made manually (when the drug was added or edited). You must have the Administer Signal Management permission to modify automatic review assignments.
• Manage Designated Medical Events: 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 associated with particular products. You must have the Manage Signaling Terms permission to manage DMEs.
• Manage Custom Terms: You can create custom terms to represent a pseudo-value for a product or event. You must have the Manage Signaling Terms permission to manage custom terms.
• Manage Views: You can rename, publish, delete, or reorganize saved views. You must have the Manage Signal Views permission to manage Views.