Enable EMA Clinical Trial Submissions: Non-Study Suspect Products

Learn how to configure your Vault to support submitting Clinical Trial Cases to the EMA with the Spontaneous Report Type.

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

With the 23R3 release, Vault Safety supports submitting Clinical Trial Cases with the Spontaneous Report Type. This feature aligns with the European Union (EU) Good Vigilance Practice (GVP) Module VI guidelines, particularly for Clinical Trial Cases involving adverse events related solely to non-investigational medicinal products available in the EU. To accomplish this, a new Report Type Override field on Transmissions enables overriding the Report Type at the Transmission level. This feature enhances compliance with regulatory requirements.

Once you have configured the feature, see Create a Submission and E2B Generation Data Mapping: EMA E2B(R3) for more details.

Add Report Type Override to Transmission Page Layouts

Complete the following steps to add the Report Type Override field to the Transmission object:

  1. Go to Admin > Configuration > Objects > Transmission > Page Layouts > Submission Detail Page Layout.
  2. In the Details section, add the Report Type Override field.
  3. Select Save.