Enable PMDA Submission Rule Parameter Updates

Learn how to configure your Vault with the latest rule parameter updates for PMDA Submissions.

Last Updated

Note Beginning with 24R1 in April 2024 and for all subsequent releases, the new Vault Safety Help site is the official site for all Vault Safety Help content. This site reflects updates until the 23R3 release only. For the latest information, visit the new site.

About the Feature

In 23R1, Vault Safety introduced support for multiple PMDA Submissions from a single Case, with the plan to update the associated Reporting Rule Parameters in a later release. With 23R2, the PMDA Rule Parameters now leverage the new and changed fields, including Registration Type, Infection, and Special Report Classification. In addition, this release introduces the Previously Localized Rule Parameter. These updates support PMDA requirements for calculating due dates.

After configuring this feature, see Reporting Rule Parameter Reference for more information.

Update the Active PMDA ICSR Reporting Rule Set

Complete the steps below to update the active rule version on the PMDA ICSR Reporting Rule Set:

  1. Go to Business Admin > Objects > Safety Rule Sets > PMDA ICSR Reporting Rule Set.
  2. Select Edit
  3. In the Active Rule Version field, enter "2".
  4. Select Save.