Veeva Disclosures allows sponsors the ability to centralize and streamline the clinical disclosure management process by accelerating registry submissions and improving compliance with global regulations.
Note: Veeva Disclosures is an add-on application to Veeva CTMS and part of the Clinical Operations application family. You must have Veeva CTMS and Veeva eTMF to use Veeva Disclosures. Contact your Veeva representative for more information.
Veeva 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.
Veeva 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 US registrations
- Generate and submit US study results and documents
Veeva Disclosures is part of the Veeva Clinical Operations family of applications. Within a single Vault, your organization can have one, two, 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. Veeva Disclosures represents these individuals via the following roles:
Disclosure Specialist
This user creates and completes new disclosures. Veeva 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.
About Disclosure Types
Vault utilizes Disclosure Types to allow you to create and submit the required disclosures to supported regional authorities. The Authority you select when creating a Disclosure determines the available Disclosure Type options. Vault currently supports the ClinicalTrials.gov regional authorities, EU CTIS authorities, and the Other authority to allow you to create generic Disclosure records not tied to any specific authority.
US Protocol Registration
The US Protocol Registration disclosure type allows you to enter the required information to register a clinical trial protocol on the ClinicalTrials.gov registry. In the Disclosure Subtype field, you can select the Initial Protocol Registration or Protocol Registration Update disclosure subtype based on the stage of your study and protocol. When creating a US Protocol Registration, select a Protocol record to prepopulate data into the Disclosure record. Vault validates the data in the US Protocol Registration record based on ClinicalTrials.gov requirements before generating and submitting the submission file to ClinicalTrials.gov.
US Results
The US Results disclosure type allows you to enter the study results tables, listings, and figures in a Disclosure record that users can edit, review, and approve. Vault validates the data in the US Results Disclosure record based on the ClinicalTrials.gov requirements before generating and submitting the submission file to ClinicalTrials.gov.
US Delayed Results
The US Delayed Results disclosure type allows you to enter details for reporting delayed results in a Disclosure record that users can edit, review, and approve. In the Disclosure Subtype field, you can select the Certification of Initial Approval or New Use or Extension disclosure subtype based on the stage of your study. Vault validates the data in the US Delayed Results Disclosure record based on the ClinicalTrials.gov requirements before generating and submitting the submission file to ClinicalTrials.gov.
EU Applications (CTAs - Clinical Trial Applications)
The EU Application disclosure type allows you to compile required clinical data and supporting documents for Clinical Trial Application submissions aligned with EU CTIS requirements. Vault supports initial filings as well as modification Disclosures. Users have these options available in the Disclosure Subtype field:
- Initial Application: Captures initial application data and documents.
- Substantial Modification: Drafts modification applications by automatically copying study data and supporting documents from initial filings to prevent manual duplication.
- Non-Substantial Modification: Captures minor modifications and automatically hides sections not required for non-substantial updates.
- Additional Member State Concerned (MSC): Drafts applications to add member states while copying relevant trial data from initial filings.
EU Notifications
The EU Notification disclosure type allows you to track when to log updates in the CTIS Portal for Recruitment Status changes, Start, Halt, Restart, and End dates, as well as Unexpected Event notifications. Form data directly aligns with EU CTIS requirements.