New in AERS Signal Management for the Oracle Empirica Signal 9.0 Release
After upgrading AERS Signal Management 8.x for use with Oracle Empirica Signal 9.0, signal configurations will support configurable alert types.
Configurable alert types are based on Review period or Complexity level/ periodicity. This allows for the scheduling of an alert based on the product properties of review period, complexity level, and birthdate.
Alert types can be informational or tracked. The Signal Review page measures the user’s tracked alert review progress with review/total counts and graphical displays. When the user completes Submit Review on a product-event combination for which there is at least one un-reviewed alert, the tracked alert reviewed counts and alert graphs update to reflect that the tracked alert(s) have been reviewed. Informational alerts counts are static and do not contribute to the product’s alerts reviewed progress. By default, all standard alerts are review-period-based and informational. The standard set of configurable alerts types can be modified and permissioned users can configure new alert types.
New standard product properties are available: Display name, Category, Complexity level, Birthdate, and Organization. Complexity level and Birthdate contribute to Complexity level-based alert types. Signal administrators define acceptable values for: Category, Complexity level, and Organization.
After upgrading AERS Signal Management 8.x for use with Oracle Empirica Signal 9.0, the view category, Drug Overview Alerts, will be referred to as Product Alerts.
- 20002214 - Open views reference Pending Case Review
Previously, the "Open signals" and "Open signals - new cases" views referenced an obsolete comment type, "Pending Case Review," in the SQL WHERE clause. - 28931081 - Only first review period views are populated
Previously, views were only populated for the signal configuration’s first review period. This made it difficult to enable and use the Review Periods feature. - 29319493 - Distinguish between Comments & Private Comment Column Types
Previously, in the AERS signal configuration, the Drug-Event Columns table referenced column type Note for both Comments and Private Comments and column type Note Date for both Comment Dates and Private Comment Dates.
Parent topic: FDA AERS Signal Management Release Notes