Enable Show Unmasked Open-Label Products on Blinded Forms

Learn how to configure your Vault to unmask open-label Products within blinded Studies on blinded CIOMS I and FDA 3500A forms.

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 22R2 release, Vault Safety introduced the option to always unmask open-label Products within blinded Studies on blinded CIOMS I and FDA 3500A forms. The feature was originally introduced with Support-enablement. In 23R3, the feature is enabled through an Admin Checkbox.

Enabling this option does not impact previously generated reports, which must be re-generated to be updated.

If this behavior is not turned on, blinded reports continue to mask open-label Products within blinded Studies by default.

Note If Veeva Support previously enabled this feature in your Vault, you do not need to take any action. In your Vault’s Submission and Distribution Settings, the Display Unmasked Open-label Products on Blinded CIOMS and MedWatch 3500A checkbox is automatically selected.

For more information on these reports, see CIOMS I Generation Data Mapping and FDA 3500A Generation Data Mapping.

Turn On Unmasked Open-Label Products on Blinded Forms

Complete the following steps to turn on the Unmasked Open-Label Products on Blinded Forms feature in your Vault:

  1. Go to Admin > Settings > Submission and Distribution Settings.
  2. Select Edit.
  3. Select the Display Unmasked Open-label Products on Blinded CIOMS and MedWatch 3500A checkbox.
  4. Select Save.