Introduction

These release notes describe interactive FDA AERS Signal Management for use with Oracle Empirica Signal version 9.2.x.x with FDA AERS data 2017Q3 or later.

Interactive FDA AERS Signal Management is the Signal Management feature of Oracle Empirica Signal as used with the FOI (Freedom of Information) FDA spontaneous adverse event reports (FAERS) database. Oracle refers to this data as AERS. The AERS database includes all SRS (pre-1997) and AERS data for all medical products licensed for marketing in the US and is updated and released quarterly by the FDA.

Oracle prepares quarterly AERS data for use with Oracle Empirica Signal. Each quarter, your system administrator installs the new AERS data and runs a set of MGPS data mining runs to refresh the statistics reported by Signal Management, including report counts (N) and EB05, EBGM, and EB95 scores. These release notes describe the database restrictions that identify subpopulations or types of cases within the AERS database, the data mining runs that are used to produce scores reported by Signal Management, and the options you have for displaying the AERS data and generated statistics in Signal Management.

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