PMDA JADER for Signal Management is new for Oracle Empirica 9.2.3

This topic describes the PMDA JADER for Signal Management that is new for Oracle Empirica 9.2.3.

PMDA JADER (Japanese Adverse Drug Event Report) for Signal Management is now available for subscribers in Oracle Cloud.

With JADER Signal Management, you can:

Monitor a drugs and signaling terms from within Oracle Empirica.
Initiate a refresh from within Oracle Empirica.
Add alerts.
Define review periods.
Configure JADER in English or Japanese.
Update the JADER data on a quarterly basis covering three months of update data.

Also, starting from this release, defining a Serious alert will be unavailable. In JADER, the Seriousness field does not exist.

None of the .features or fixes we have applied the 9.2.3 release affect the user workflow or the application's functionality.

This database includes all data from 2004 through January 2023, as released by the Japanese authority PMDA (Pharmaceutical and Medical Devices Agency). Oracle refers to this data set as JADER 3.0.0.1.100. The purpose of these release notes is to describe the procedures taken by Oracle to prepare the JADER data for use with Empirica Signal version 9.2.3 and above. The standard configurations delivered with the data and the recommended parameters for periodic data mining runs are also described.

The use of the JADER adverse event data is subject to the PMDA terms of use, as well as the Oracle Empirica Signal Cloud Service Description available at www.oracle.com/contracts. The PMDA web site can be viewed at www.pmda.go.jp (limited information available in English).

Parent topic: PMDA JADER Signal Management Release Notes