Argus Unblinding Advanced updates

Summary

Argus Unblinding Advanced updates (Enhancements 36621715, 36673888, 36708518, 36615481, and 36752028)

Description

The following Argus Unblinding Advanced features are enhanced:

Capture follow-up receive and Safety receive date for every PRD file

For a precise due date calculation, you can manually set the following two new fields in the End Of Study Unblinding (EOSU) profile:

• File Generated Date—Date when the randomization file was generated in the Clinical system (Follow-Up received Date)
• File Received Date—Date when the randomization file was received by Safety system (Safety Received Date)

It is optional to set these dates. If the dates are not set, the EOSU profile execution date is used.

Ability to download PRD file from EOSU profile

You can download the latest Patient Randomization Data (PRD) file that was loaded in the EOSU Profile.

The existing Download button, which previously downloaded the PRD Loading report, now downloads both the PRD file and the Loading report as a zipped file.

Note:

The PRD files loaded before Argus 8.4.4 upgrade are not downloadable. For these files, the Download button only downloads the .txt loading report.

Allow blank reporting group

You can configure and execute an EOSU Profile without assigning an Expedited Reports Group, even if the option to run reports is selected. In such cases, the responsible group remains blank in the scheduled report.

If the reporting rule includes a Responsible Group, that group is allocated to the report.

Restrict automatic archiving of unblinded cases without reports

For greater flexibility to process the unblinded cases without reporting, the cases are not automatically archived. Unblinded cases with no reports are assigned a workflow state based on the current functionality, but are not archived unless the workflow state is Closed. Cases with workflow state as Closed are archived automatically.

Deprecated Argus Unblinding Client-Server tool

The Argus Unblinding client-server module for End-of-Study Unblinding is deprecated from this release. The existing profiles, setup parameters, and logs will reflect in the Utilities > Unblinding Advanced screen.