These release notes describe PMDA JADER Interactive Signal Management for use with Oracle Empirica version 9.2.3 with JADER data 202409 or later.

The Oracle Empirica software is a web-based analysis environment for generating statistical scores or combinations of drugs and events in a drug safety database, and for detecting unexpected associations of drugs and events (signals).

If your organization subscribes to Oracle Empirica Topics for Signal Management Cloud Service and the Empirica Signal PMDA JADER Database, you can use the Signal Management feature in Oracle Empirica Signal on JADER data. If your organization has not used JADER Signal Management before, contact Life Sciences Support to enable the feature in your environment. The feature facilitates ongoing monitoring of safety signals by allowing users to perform statistical analysis on successive releases of the data.

Interactive signal management allows configuring and refreshing signal management from the user interface rather than using scripts. This release also makes use of the configurable alerts feature introduced in Oracle Empirica 9.0.

JADER Interactive Signal Management requires JADER data 202409 or later but can be used with any 9.x release of Oracle Empirica. R and RGPS packages must be installed on the Empirica Signal application server and RGPS must be configured in Oracle Empirica Signal.

For more information on a monthly JADER data release, please refer to the JADER Database Release Notes.pdf file distributed with the release. That document describes the preparation of JADER data for use with Oracle Empirica Signal, including Oracle tables and table views, record counts, duplicate removal, standard data configurations, and a complete data mining table schema.