Enable Japan One Last Time Reporting

Learn how to configure your Vault to provide One Last Time (OLT) reporting for Japan.

About the Feature

With the 24R1 release, Vault Safety added One Last Time (OLT) reporting for Japan for Submissions to the Pharmaceuticals and Medical Devices Agency (PMDA). This extends the OLT Reporting for All Destinations feature that Vault Safety introduced in the 23R2 release.

Follow the steps below to enable Japan OLT reporting in your Vault.

Prerequisites

Configure One Last Time Reporting for Japan

  1. Go to Admin > Settings > ICSR Reporting Settings and select Edit.
  2. From the One Last Time Reporting for Japan dropdown, select one of the following three (3) options, depending on how you want Japan/PMDA OLT reporting configured in your Vault:
    1. (blank): Vault uses the One Last Time Reporting ICSR setting as described in Enable One Last Time Reporting for All Destinations.
      If the One Last Time Reporting ICSR setting is set to blank, Vault uses Case-level OLT reporting using the Safety Rule Engine only which does not apply to LRD-level Submissions.
    2. ACK Accepted/Completed: Vault uses the Rules in option 1 and creates additional Japan/PMDA OLT reporting in the ACK Accepted or Completed Transmission states1.
    3. All Transmission States: Vault uses the Rules in option 1 and creates additional Japan/PMDA OLT reporting destinations in all Transmission states1.
  3. Enter a number in the Due in Days for Local OLT Submissions field. Vault uses this value to populate the Due in Days field for all Local OLT Submissions1. This field only appears if you selected a non-blank option in step 2.
  4. Save your changes.