Vault Disclosures allows you to create and edit Disclosure records to store and manage information for clinical trial disclosures, and generate disclosure submission files for supported registries. Vault Disclosures is configured and usable upon deployment; however, Admins can configure the application to reflect their company’s processes.
Note: Veeva Support must enable Vault Disclosures in your Vault. 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 Components
Vault includes the following components for configuring Vault Disclosures:
- Disclosure Object (
disclosure__v): Contains the key clinical trial disclosure information used for submission to clinical registries - Disclosure Object Lifecycle (
disclosure_lifecycle__v): Allows you to move Disclosure records through the lifecycle states to reflect the creation, editing, approval, and submission of the record - Disclosure Rules: Contains rules that trigger the creation of a Disclosure record for supported registries
About the Disclosure Object
The Disclosure object has the Disclosure Overview and Disclosure Form layouts that store the disclosure information used for clinical registry submissions. Admins can configure the Disclosure Overview page layout. We recommend adding the Content Last Modified By and Content Last Modified fields to the System Details section of the Disclosure Overview page layout.
About the Disclosure Lifecycle
Vault Disclosures includes the standard Disclosure Lifecycle for the Disclosure object. This lifecycle includes the following states:
- Draft: The initial state of Disclosure records. Users are updating the Disclosure record in this state.
- In Review: Vault Disclosure users, like the Disclosure Reviewer, are reviewing the record.
- Ready for Approval: Reviewers have approved the Disclosure record.
- Approved: All necessary members have approved the record. As originally configured, the Disclosure record must pass the Validate Disclosure entry action to enter this lifecycle state.
- Submitted: A user submitted the Disclosure record to a registry.
- Inactive: The Disclosure record is inactive and is not currently moving through the Disclosure Lifecycle.
Configuring Disclosure Lifecycle Entry Actions
The Disclosure Lifecycle has three unique entry actions: Unlock XML, Lock XML, and Validate Disclosure. The Unlock XML and Lock XML entry actions enable and disable the Generate Disclosure XML user action. The Validate Disclosure entry action runs a validation check on the Disclosure record to ensure all supported registry validations are resolved before entering the lifecycle state. Admins can configure the Unlock XML, Lock XML, and Validate Disclosure entry actions on any lifecycle state.
About Disclosure Rules
Disclosure Rules control the user actions that trigger Vault to create Initial Protocol Registration and Protocol Registration Update records for supported registries. Admins can change the Due Date Shift value on a rule to add additional days before the compliance due date and change the Status of any rule to Inactive for rules they do not want Vault Disclosures to use. To configure Disclosure Rules, navigate to Admin > Configuration > Clinical Configurations > Disclosure Rules.
Configuring Disclosure Workflows
The Disclosure Lifecycle and Disclosure Rules use workflows to assign tasks and notify users of changes made to Disclosure records. Admins can configure workflows to customize the users that Vault notifies and the tasks that Vault assigns. These workflows control the review process of Disclosure records as they move through the lifecycle.
Related Permissions
You can complete all steps in this article with the standard Business Admin, System Admin, or Vault Owner profile. The following permissions control the ability to configure Vault Disclosures components within Vault. If your Vault uses custom security profiles, your profile must have the following permissions:
| Permission Type | Permission | Controls |
|---|---|---|
| Security Profile | Admin: Object Lifecycles: Read, Edit | Ability to configure the Disclosure Lifecycle and the Unlock XML, Lock XML, and Validate Disclosure entry actions |
| Security Profile | Object: Disclosures: Create, Edit, Delete | Ability to create, update, and delete Disclosure records and the Disclosure page layouts |
| Security Profile | Admin: Object Workflows: Read, Create, Edit | Ability to view, create, and configure object workflows |
| Security Profile | Admin: Disclosure Rules: Read, Edit | Ability to view Disclosure Rules |
| Security Profile | Application: API: Metadata API | Ability to edit Disclosure Rules |