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. You can use Vault Disclosures 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.
Configuration Overview
- Add the Content Last Modified By and Content Last Modified fields to Disclosure Overview page layout.
- Add the Unlock XML, Lock XML, and Validate Disclosure entry actions to the appropriate Disclosure Lifecycle lifecycle states.
- Configure a workflow for the Disclosure Lifecycle.
- Optional: Configure Disclosure Rules to trigger Disclosure record creation.
- Configure the connection to ClinicalTrials.gov Protocol Registration and Results System (PRS).
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 add the Unlock XML, Lock XML, and Validate Disclosure entry actions to Disclosure Lifecycle lifecycle states.
Configuring Disclosure Rules
Disclosure Rules control the user actions that trigger Vault to create Disclosure 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 ClinicalTrial.gov Disclosure Submission Connection
Vault supports the submission of US Disclosure records directly to ClinicalTrials.govs Protocol Registration and Results System (PRS). US Disclosures will have the Generate and Submit action in the All Actions menu once an Admin configures the ClinicalTrials.gov PRS connection.
To configure the connection to ClinicalTrials.gov PRS:
- Navigate to Admin > Connections.
- Select Create and select External from the dropdown list.
- Enter the Name.
- Enter the API Name.
- Enter the URL for the ClinicalTrials.gov website. For a test connection, enter the https://prstest.clinicaltrials.gov URL. For a production connection, enter the https://prs.clinicaltrials.gov URL.
- Click into the Authorization field and select Create Connection Authorization.
- Select Basic Auth from the dropdown list.
- In the Create Basic Auth, enter any Name for the Connection Authorization.
- Enter your ClinicalTrials.gov Username in the Username field.
- Select Save.
- Open the All Actions menu for the Basic Auth and select Set Password.
- Enter your ClinicalTrials.gov Password.
- Select Save for Set Password.
- Enter the Organization Name associated with your ClinicalTrials.gov PRS account. If you do not see the Organization Name field, add the Organization Name field to the page layout.
- Select Save for External Connection.
Once you configure the ClinicalTrial.gov connection, you can select the Generate and Submit user action on US Disclosures in the Approved state to submit the Disclosure.
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 |
| Security Profile | Application: Manage Connections | Ability to view and configure Connections |