Enable Clinical Trials: Isolate Blinded Product Information

Learn how to configure your Vault to isolate blinded Product information.

About the Feature

The Clinical Trials: Isolate Blinded Product Information feature lays the foundation for Vault Safety’s most advanced approach to protecting blinded information for Clinical Trial Study Cases. We recommend adopting this feature to ensure optimal processing of your blinded Clinical Trial Study Cases from start to finish. This feature offers the following significant advantages over other methods of managing Case blinding:

  • Dual records preserve all of the information from before and after unblinding for all global and localized records
  • Support for independent assessments of unblinded Case Products during the Medical Review process
  • Blind protection supports overall clinical trial integrity when distributing SUSARs to ethics committees and study sites
  • Accurate reporting to both regulatory and non-regulatory health authorities
  • A clear user interface to help users easily differentiate blinded from unblinded information

For more information about using this feature, see Isolate Blinded Clinical Trial Information.

Prerequisites

To enable the Clinical Trials: Isolate Blinded Product Information feature in your Vault, your Admin must contact Veeva Support.

In addition, consider the following prerequisites for using this feature:

  • Your Vault must use Inbox Items.
  • Your Vault must have Case Access Group Security configured.
  • Your Vault must use Action Layouts.
  • For existing Clinical Trial Study Cases, your Admin must generate the Blinding Type and Blinded Reference details.
  • (If applicable) You must update Narrative Templates with merge fields or tokens that return blinded information so that the Blinding Type returns in the same merge field or token.
  • (If applicable) You must review custom reports for potential impact.

Recommendations

In addition to the prerequisites, we recommend the following setup for working with the Clinical Trials: Isolate Blinded Product Information feature: