Overview

ExtraView 7.0.3 or greater is required to support the functionality of the Adverse Events solution. The out-of-the-box Adverse Events solution has the following ExtraView basic configuration:

  • Business areas named Incident, CAPA, Adverse Event
  • Layouts within the business areas to add and update Adverse Events, and layouts for built-in reports. There are also layouts that assist with the selection of incident summaries, device details, pharma details, and CAPAs to add to the incidents. In the initial configuration, you will choose whether to use layouts associated with pharma compounds or with medical devices
  • A set of fields that belong to and support these business areas
  • A "usercustom" JavaScript class named UserJavaScript.js that contains some customized functionality on which the solution depends. This is installed with the solution
  • A demonstration MedDRA dictionary. This is fully integrated with ExtraView.
     
    Note that the MedDRA dictionary is licensed independently of ExtraView. You must maintain a subscription license with the MedDRA MSSO. The adverse event solution ships with a subset of the MedDRA database for demonstration purposes
  • A set of reports to use with the solution.

The Add and Edit layouts are used by end users of the solution, to enter and to update information. Incident specifics such as the Patient Details, Reporter Details, and Incident Summary are entered directly into the Incident business area. When an incident exists in the Incident business area, the details of that case can be seen directly within the issue that is created.

One or more Adverse Events is attached to any Incident. Adverse Events can be added at the time you create the initial Incident or when you update the Incident. When creating or updating an Adverse Event, you may search the inbuilt MedDRA database and attach the relevant MedDRA terms to the Adverse Event.

One or more CAPAs may be attached to any Incident. These may be entered when you are updating the Incident. CAPAs may also be created independently of Incidents.

The default solution provided will work for many companies, but it is straightforward for your administrator to change this to suit your company. Alternatively, ExtraView's Professional Services team can assist with this task.

ExtraView Adverse Event Add Screen