Vault Disclosures Overview

Vault Disclosures allows sponsors the ability to centralize and streamline the clinical disclosure management process by accelerating registry submissions and improving compliance with global regulations.

Vault Disclosures stores and manages information required for clinical trial disclosures, 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
• Generate and submit disclosure files 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 Roles

The clinical trial disclosure 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 before approval and submission.