Expedited Reporting Rules Algorithm

The expedited reporting rules algorithm affects the following:

• Suppression of Duplicate Reports
• Blinded/Forced Distribution
• Letter Placeholder for the IND Cover Letter

Suppression of Duplicate Reports

You can suppress duplicate expedited reports to be scheduled at the reporting destination level by using the Suppress Duplicate Reports option.

This option:

• Determines the system to use the following attributes to determine whether the reports are duplicates of other reports:
• • Report Form
  • Reporting Destination
  • Aware Date

• Only applies to drug reports. It does not apply to device reports.
• Does not reduce the number of reporting rules the system evaluates. However, it does prevent the system from scheduling and generating expedited reports that match the duplication criteria.

Blinded/Forced Distribution

You can configure the Blinded Study option for products in a study to blind the products for the report being sent to the reporting destination. The functionality is similar to the corresponding option from the Bulk Reporting dialog box.

• If you select either of the Blinded 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 report is due 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 boxs.
  • 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; SYSTEM is the user.