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.

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.