Signal management is an optional feature in Empirica Signal. You use signal management to continually monitor safety signals using disproportionality analysis statistics for successive updates of safety data.
Oracle prepares signal management from the combined results of multiple data mining runs. While preparing the data, Oracle defines signal sets. A signal set is a compilation of signals from data mining runs that have a particular characteristic in common. For example, Oracle might define a signal set named Foreign to include only signals from foreign reports.
Empirica Signal displays signal management data on the Signals tab, where you can:
To view the Signals tab, you must have the View Signal Management user permission, and a signal configuration must be associated with your login group.
The following additional features might also be available if your organization enabled them:
Use topics to follow up on potential signals. For more information, see About topics.
Use drill down to perform manual reviews of case reports. Case reports can help you perform clinical assessments or determine event causality.
Use review periods to review safety signal data for the period of time that is most appropriate for each drug.
Public comments can be viewed by all users. Private comments can be viewed by the comment author or a superuser, or by all users if the comment is associated with a drug-event combination that is attached to a topic.