PMDA device paper reports for a legacy case

The old Form 8 and Form 10 paper report was generated using editable word template provided by PMDA having form fields. Hence, the labels were not editable, and the data were editable. In Oracle Argus Safety the enhanced report is fully editable.

Any existing report in state generated or above, old layout of Form 8 and Form 10 continue to work. So it is recommended that you do not have any reports in scheduled or new data available state prior an upgrade to avoid errors.

If Form 8 or Form 10 paper report is submitted prior to an upgrade, having the old reporting category and data, after the upgrade AG service auto-schedules the follow-up report. If you try to generate an already auto-scheduled follow-up report after unlocking and selecting new reporting category and data, the application returns an error message since the case had old data when the service was auto-scheduled. This is due to the old reporting category which is no longer an allowed value. It is recommended that you delete the auto-scheduled follow-up report for the paper report after the upgrade and allow the service to auto-schedule again after updating the case data as required for the updated paper reports.