Introduction

These release notes describe Vigibase Interactive Signal Management for use with Oracle Empirica Signal version 9.x with Vigibase data 2018Q2 or later.

The Oracle Empirica Signal software is a web-based analysis environment for generating statistical scores for 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 Oracle Empirica Signal WHO UMC Vigibase Extract Cloud Service, you can employ the Signal Management feature in Oracle Empirica Signal on Vigibase data. If your organization has not used Vigibase Signal Management before, contact Oracle Support to enable the feature in your environment. The feature facilitates ongoing monitoring of safety signals by enabling users to perform statistical analyses on successive releases of the data.

A scripted form of Vigibase Signal Management was originally released in 2005. In scripted Vigibase Signal Management, quarterly refreshes are initiated by running shell scripts on the server. Scripted Vigibase Signal Management can be used with Oracle Empirica Signal versions 7.3.x and above.

Vigibase Interactive Signal Management is being introduced in Oracle Empirica Signal 9.1.0.4. 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 Signal 9.0. If scripted Vigibase Signal Management was used previously, there is an optional conversion process to copy information from the old scripted Vigibase Signal Management into a newly installed Vigibase Interactive Signal Management.

Vigibase Interactive Signal Management requires Vigibase data 2018Q2 or later but can be used with any 9.x release of Oracle Empirica Signal.

For more information on a quarterly Vigibase data release, please refer to the Vigibase Data Release Notes.pdf file distributed with the release. That document describes the preparation of Vigibase 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.