Blinded or forced distribution

The system enables you to configure the Blinding Study option for products in the case.

  • When you check this checkbox, the system blinds the study products for the report being sent to the reporting destination in a manner similar to the Bulk Reporting dialog box option.
  • If you select either of the Blind Study product options (Reporting Rules or Bulk Reporting), the system blinds the study product information on the report form.
  • The system blinds only active blinded studies. It does not blind the following case reports even if the Blind Study product is selected.
    • Open Label Studies
    • Study is eligible for unblinding - If the Study is Unblinding checkbox is not kept as unchecked in study configuration, the user will be able to see the complete case data even if he/she has protection enabled.

      When the case contains a blinded study, for the user who has access to unblinded data, the report scheduling screen displays the product name and licenses only as a placeholder product based on the primary license. This is done to support the report scheduling framework that requires a product and license. This is not the true product that the patient received yet.

      For restricted user, Argus does not allow reporting scheduling and displays the message as Case must have a Company Suspect Product to view reports.

In cases where expedited reports are due, the system permits the user to force-distribute the reports based on user-defined reporting rules, even if case processing is incomplete.

When you select the Force Distribution rule, the following occurs:

  • If a case encounters a rule where a due report is locked, the system schedules the report based on the rule and does the following:
    • Generates the report on the due date.
    • Dynamically replaces the current case comment with the force distribution case comment.
    • Transmits the report based on the preferences defined by the reporting destinations.
    • Displays the status in the Worklist Bulk Transmit/Transmit ICSR dialog box.
  • The AG Service Force Reporting process for expedited reports completes the process by:
    • Checking the reports required for force distribution
    • Locks the case (if it's not already locked)
    • Generates the reports and makes sure it is ready for transmission
  • The notes for the Case Locking/Unlocking are the same as those defined as the common profile value for the Forces Distribution option; the system is the user.

Parent topic: What components are affected by the expedited reporting rules algorithm?