Ability to convert an AERS signal configuration from scripted to interactive

A mechanism for converting a scripted signal configuration to a new interactive signal configuration is available.

The conversion will preserve:

  • Monitored drug list.
  • Keep under review (KUR) events, which are referred to as Targeted Medical Events (TMEs) in interactive Signal Management.
  • Listed (labeled) events.
  • Designated medical events.
  • Custom drug and event terms.
  • Reviewer assignments for drugs and drug-event combinations.
  • Custom comment types.
  • Comment history (both public and private) for drug-event combinations.
  • Associated topics for drug-event combinations.
  • Drug notes.
  • Custom views for the Drug-Event Combinations page including publication status.
  • Signal configuration properties including name, description, integrated topic workflow configuration and topic product field, default view, and properties for runs including the drug variable, event variables for 2D and 3D runs, stratification and subset variables, and the project for runs.

The conversion will not preserve:

  • Customizations to Drug Overviews column labels, tooltips, or to associated views.
  • Customizations to Drug-Event Combinations column labels or tooltips.
  • Information that distinguishes "Ongoing" from "**NEW**" alerts.

    Following the first refresh after conversion, all alerts appear as "**NEW**". The Oracle Empirica Signal application makes the distinction between "Ongoing" and "**NEW**" for subsequent refreshes.

  • KUR Only events.

    Interactive AERS Signal Management cannot limit the events monitored for a drug to only those that are in the Keep Under Review list. All events will be monitored.

  • Any changes not yet processed in a refresh of your scripted AERS Signal Management. For example, drugs to add, rename, or delete, or changes to listed (labeled), designated medical, or KUR events.

For more information, see AERS Signal Management for User with Empirica Signal 9.0 Installation Instructions .