Learn how to configure your Vault to unmask open-label Products within blinded Studies on blinded CIOMS I and FDA 3500A forms.
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:
- Go to Admin > Settings > Submission and Distribution Settings.
- Select Edit.
- Select the Display Unmasked Open-label Products on Blinded CIOMS and MedWatch 3500A checkbox.
- Select Save.