Bulk End-of-Study Unblinding (EOSU) Web Interface

Summary

Argus Unblinding integration with Argus Safety for Bulk End-of-Study Unblinding (EOSU) (Enh 35522165)

Description

End-of-Study Unblinding (EOSU) is the process in which a blinded study is unblinded after the study ends and investigators and/or participants are informed which treatment the participant is receiving. When the study is unblinded in the clinical system, the safety cases for same must be unblinded in the safety system. This activity is usually performed in bulk for all the cases belonging to the study.

Currently, Argus supports the functionality of End-of-Study Unblinding via Argus Unblinding, a client-server integration module available only from the web server and not from the Argus Safety user interface.

Argus 8.4.3 is enhanced to integrate the functionality of bulk End-of-Study Unblinding through an intuitive web interface in Argus Safety.

The new interface can be accessed from Argus > Utilities > Argus Unblinding. This interface is available for the users that belong to a user group with menu access to Argus Unblinding.

Argus Unblinding web application provides two options to perform unblinding of cases.

• Unblinding Lite: This feature is same as the existing End of Study functionality available under the Utilities menu but renamed to Unblinding Lite. It enables you to perform unblinding on cases by case basis.
• Unblinding Advanced: This new feature allows you to create, maintain, and track End-of-Study Unblinding profiles and view profile status. It also enables you to generate a Study Case Report for a Profile/Study ID, which details the cases present in Argus Safety for that study.

To perform Advanced (Bulk) End-of-Study Unblinding, you need to:

1. Create a new End-of-Study Unblinding profile and configure it with the necessary settings as described in the following steps.
2. Select the Study ID from available look up.

   Bulk unblinding can be performed on cases belonging to a specific study that is configured in Argus Safety and is eligible for unblinding.

3. Load the patient randomization data [PRD] file in a prescribed format.

   A PRD template is provided out of the box, which can be downloaded and used to create the PRD file. When the PRD file is successfully uploaded, a loading report is available for download. The PRD files can be overwritten with new files in the same profile.

   Note:

   Randomization data must be obtained from the Clinical system, and refined as per the PRD template provided in Argus before loading it in the Unblinding tool.
4. Optionally, select or create a new advanced condition to filter the cases that are to be unblinded.
5. Map the treatment codes to the study drug to be used for unblinding. Multiple study drugs can be mapped for one treatment code.

   Optionally, dosages can be configured too. There are multiple dosage options available that enables you to add a new dosages, replace the existing dosages, or delete the existing dosages.

6. Optionally, add a narrative text that is appended to the case after unblinding. The default narrative text appears as Case unblinded due to end of study, and is editable.
7. If no expedited reports have been scheduled by the unblinding procedure, select a workflow state into which the unblinded case is to be moved. By default, the workflow state, Closed archives the case after unblinding.
8. You can run reporting rules on the unblinded case by checking the Run Reporting Rules check box.

   This enables auto-scheduling of the reports based on the existing reporting rules. When this option is checked, select the Reporting workflow state and Expedited reports group to assign the unblinded cases with the scheduled reports to a workflow state and the report to a reporting group.

9. After all the configurations are completed, the unblinding process can be executed in any one of the following modes:
   • Dry Run mode: This is the default mode. This mode acts as a preview for the unblinding execution. It produces the execution log files and exception log files without actually unblinding the cases and saving the changes to the database.
   • Update Mode: This mode commits all the changes done during the unblinding process to the database. The execution and exception logs are generated with details.

The unblinding execution is carried out by a new out-of-the-box AG service task, End Of Study Unblinding. As the unblinding execution process happens in the backend, you can navigate out of unblinding and perform other tasks in Argus.

The unblinding process performs below actions on each valid case that qualify for unblinding based on the profile configuration.

• Create significant followup.
• Set case blinding status as Unblinded, and sets Unblinding Date to system date and time.
• Set the study product and update dosage.
• Append narrative.
• Re-lock the case and re-assess listedness.
• Update the case audit log and create a new revision of the case.
• Schedule reports as per the auto-scheduling algorithm, if reporting is enabled for the profile.
• Assign the case to a workflow state as configured in the profile.
• Archive the case, if the workflow state is set to Closed.

After completion of the unblinding execution, process log and execution logs are generated that can be downloaded for review.