Performing Case Triage and Assessment

Triage in Safety means prioritizing and processing the case for completeness of information for reporting to authorities.  The information is assessed, classified and prioritized according to the key regulatory criteria and business process, to submit timely reports to the authorities. The management of such information is very critical and essential for the pharmaceutical companies. 

In the Triage and Assessment screen, ARISg facilitates to store information on Drug, Case Seriousness criteria, Event information, Latency, SUSAR notification, Causality, and Labeling information. In addition to Triage and Assessment screen, the above mentioned fields are available in Full Data Entry also. When you enter information or modify any of the above mentioned fields, the corresponding field is updated in the other location.

1. Click Forms > Triage and Assessment. Alternatively use CTRL+ALT+H to open the Triage and Assessment screen.
   The Triage and Assessment screen appears.
2. Enter Drug information. The following fields are available in Forms > General > Product tab also.

• Product Description

• Product flag

• Product class

• Therapy Start date

• Therapy End date fields

3. Click the greater than sign button to enter multiple product records.

4. Enter Case Seriousness criteria. Click to enter Other AE characteristics. In addition to Triage and Assessment screen, the Case Seriousness is available in Forms > Event tab also. (For field description, refer to the section Capturing Event Information)

5. Add a study record with code broken as Yes.

6.  Enter Event information. The fields are available in Forms > General > Event tab also. Click the greater than sign button to enter multiple reaction records.

7.  Enter information in Verify Action Taken With Drug section. The fields synchronize with  Full Data Entry > Causality > icon for the respective Product-Event combination.

8. Enter the Latency information for the Product-Reaction combination. Use the manual checkbox to change the values. The changes are displayed in the product reaction combination of other screens. (For field description, refer to the section Full Data Entry > Causality > AER Causality)

9. The SUSAR Notification is displayed from Full Data Entry > General screen. If required, use the Manual checkbox to change the values.
The Assessment  and Causality information grid displays the following:

• Reported Term from FDE > Event screen

• Time flag from FDE > Event screen

• Reporter Seriousnes from FDE > Event screen

• Company Seriousnes from FDE > Event screen

• Reporter Causality from  FDE > Causality screen

• Company Causality FDE > Causality screen

10. The Labeling information grid displays the information from Full Data Entry > Labeling tab. Alternatively you can use Add and Delete buttons to enter and delete the labeling information from the grid.( (For field description, refer to the section Full Data Entry > Labeling)

11. Save the case.