Vault Disclosures gives sponsors the ability to centralize and streamline the clinical disclosure management process by accelerating registry submissions and improving compliance across global regulations.
Note: Vault Disclosures is an add-on application to Vault CTMS and is a part of the Clinical Operations application family. You must have Vault CTMS and Vault eTMF to use Vault Disclosures. Contact your Veeva representative for more information.
Vault Disclosures stores and manages information required for clinical trial disclosures while also allowing users to prepare, review, approve, and submit trial disclosures within the unified Vault ecosystem.
Vault Disclosures provides the following capabilities:
- Store and manage information required for clinical trial disclosure
- Display data in an easy-to-review format
- Provide workflows for review and approval
- Manage the schedule of required registry updates
- Alert to key milestones impacting the need for registry updates
- Export disclosure to XML for US Registrations
Vault Disclosures is part of the Vault Clinical Operations family of applications. Within a single Vault, your organization can have one (1), two (2), or all of the Clinical Operations applications. These applications share a common data model, but each provides additional functionality to help manage the clinical trial process.
Disclosures Data Model and Object
Disclosure shares common data model components with CTMS, eTMF, and Study Startup Vaults. These shared components allow organizations to consolidate data for all Clinical Operations applications in a single Vault while continuing to execute business processes defined for existing applications.
Disclosure Object
In addition to the shared data model, the Disclosures application has an additional object to house data, Disclosures (disclosures__v). The Disclosures object tracks information related to the disclosure of a study, including Study, Authority, Disclosure Type, Due Date, and Study Design Type.
Disclosures Roles
The Disclosures process requires the collaboration of many individuals with separate responsibilities. Vault Disclosures represents these individuals via the following roles:
Disclosure Specialist
This user creates and completes new disclosures. Vault Disclosures notifies and assigns Disclosure Specialists to newly created and updated disclosures. This user enters disclosure data, initiates the review process, and submits disclosures to the applicable registries.
Disclosure Reviewer
This member is involved in the review and approval process of new disclosures. This user can review and comment on assigned disclosures prior to approval and submission.