1. Release Notes—What's New
  2. What's New
  3. Enhancements to Oracle Argus Safety Japan
  4. Enhanced PSR and ReSD reports

Enhanced PSR and ReSD reports

As per the latest MHLW (parent agency of PMDA) guidance, MAH can submit the PSR and ReSD reports to PMDA as per the updated format. The following has been enhanced:

  • Renamed ReSD Form 4 to Form 10 (Table).
  • Renamed ReSD Form 5 to Form 11 (Listing).
  • Added new ReSD Form 9 (Unlisted Events Table), ReSD Form 13 (Status of Overseas Measures Report), and ReSD Form 14 (Status of Study Report).
  • Deprecated existing ReSD Form 7, Form 8, and Form 9.
    • If any of these reports are in the Submitted state, the user can open it without any errors.
    • If any of these reports are in any other state than Submitted, the application validates if the reports are generated successfully after the upgrade. As these reports are marked as deprecated, in the report output, the application fetches the existing data only.
  • Impacted PSR Form 3 (Tables) and PSR Form 4 (Listing) due to changes in the ReSD Forms:

For more information, see: