New in FDA AERS Database for the Oracle Empirica Signal 9.2.2.1 Release

The default Subset variable for FDA AERS signal history has been changed from FDA_Quarter to FDA_Quarter_Init.

Prior to the change, the default subset variable was FDA_QUARTER. FDA_Quarter represents the quarter year corresponding to the FDA receipt date. This value changes with a case follow-up. This change could make it difficult to locate a case from one refresh to the next, since the case’s subset value may have changed.

For new FDA AERS signal configuration installations, the default subset variable is now FDA_Quarter_Init. FDA_Quarter_Init represents the quarter year corresponding to initial FDA receipt date. This value does not change. Therefore, a case remains in the same subset with each refresh.

For existing FDA AERS signal configuration installations, the subset variable for signal history can be modified by editing the signal configuration.