Vault Disclosures allows sponsors 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 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.
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 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.
Disclosure Records
Vault Disclosures separates Disclosure records into two layouts: a Disclosure Overview layout and a Disclosure Form layout. To navigate between layouts, use the layout picker: the drop-down menu to the left of the screen.
Disclosure Overview
All Disclosure records include the Disclosure Overview layout, which consists of the Details, Related Documents, Attachments, Workflow Timeline, and System Details sections. These sections allow you to add disclosure details unrelated to a specific registry.
Vault shows the information you used to create the Disclosure record in the Details section. When editing the Disclosure record after creation, update the expected Due Date. Once Vault or a user submits a Disclosure record, update the Submission Date.
You can add and view any documents related to the Disclosure in the Related Documents section. Click Add in the upper left corner of the section to link new documents. Vault displays the documents you link to the record in this section and the Related Documents section of the Disclosure Form layout, if available. We recommend adding all additional files needed for the Disclosure record to this section.
The Attachments section allows you to view and access all generated versions of the Disclosure record submission files and any API responses from submitting the disclosure.
Disclosure Form
Note: Only users with a layout profile including Disclosure can view the Disclosure Form layout on Disclosure records.
The Disclosure Form layout is only available for supported registry Disclosure records and allows you to add the information needed for specific registry submissions. The available sections will vary per registry and disclosure type.
When you or Vault create a Disclosure record, Vault prepopulates fields in the Disclosure Form layout. Vault does not update the prepopulated fields when Vault or a user updates the associated CTMS objects.
Protocols
The Protocol (protocol__v) object allows you to save time and improve efficiency by capturing key study protocol details, tracking changes between protocol versions, and populating consistent data into all Disclosure records.
Create new Protocol records by navigating to Business Admin > Objects > Protocols and clicking Create. You can also view and create a Protocol from a Study. Add the Protocol application section to the Study page layout to view and create Protocol records for a Study. When creating Protocol records, you can link the record to existing Protocol Documents.
Once you create a Protocol record, you can create a new Disclosure record referencing that Protocol record. When you select the Protocol record for a new Disclosure record, upon creation, Vault prepopulates the new Disclosure record with data from the Protocol record.
Note: Data in Protocol records data will only populate into US Protocol Registration disclosures.
Creating Disclosures
Vault supports the manual and automatic creation of Disclosure records. Vault will automatically create Disclosure records when a user triggers an active Disclosure Rule.
Manual Disclosure Creation
Sponsors must register study trials globally and make study disclosures throughout the study. In Vault Disclosures, you can create new disclosures from the Disclosures object tab, if available, and the Disclosures section of a Study record.
Note: To create a new US Disclosure for a Study record, you must select the Yes radio button for the Disclose Study on ClinicalTrials.gov field in the ClinicalTrials.gov Disclosure section on the Study record.
To create a new Disclosure (disclosures__v) record:
- Navigate to the Disclosures tab or the Disclosures section of the Study record you want to disclose and click Create.
- Enter the Disclosure Name.
- Search for and select a study in the Study field. When you create a new Disclosure record from the Disclosure section of a Study record, Vault populates the Study field with the selected Study.
- Select the Authority from the drop-down menu. The selected Authority determines the options for the Disclosure Type and Disclosure Version fields.
- Select the Disclosure Type from the drop-down menu. The selected Disclosure Type determines the options for the Disclosure Subtype and Disclosure Version fields.
- Select the Disclosure Subtype from the drop-down menu.
- Select the Disclosure Version from the drop-down menu.
- Enter a date in the Due Date field.
- Optional: Search for and select a country in the Study Country field. The countries from the Study populate this field as options.
- Select the Study Design Type from the drop-down menu. If left blank, this field populates with the Study Design Type.
- Optional: Enter a Comment. Users can use this field to comment on the Disclosure during the review process or to leave other comments about the Disclosure.
Creating a new Disclosure record completes the Disclosure Overview section of the record. To continue editing and adding data to the Disclosure record, navigate to the Disclosure tab, open the Disclosure record you created, and click Edit.
Automatic Disclosure Creation
Vault automatically creates Disclosure records using Disclosure Rule. Disclosure Rules store and use conditions for supported registry authorities to automatically notify users of changes in the CTMS site and study data related to disclosure key date updates and upcoming milestones that require disclosure. Admins can view and configure Disclosure Rules from Admin > Configuration > Disclosure Rules.
Note: Vault Disclosures only creates automatic Disclosure records for supported registries.
Disclosure Data Prepopulation
Vault Disclosures utilizes CTMS, eTMF, and Study Startup Vaults shared objects to prepopulate fields within the Disclosure Form layout of Disclosure records. These prepopulated fields ensure data is consistency across objects during the disclosure process for manually and automatically created Disclosure records.
Note: Vault prepopulates fields on the Disclosure Form when a user or Vault creates the Disclosure record. The prepopulated fields remain unchanged unless manually updated, even if the original data changes.
Validating Disclosures
By default, Vault validates Disclosure records for supported registries when users move them to the Approved state. Vault runs specific validation checks based on the selected supported registry. Vault indicates validation errors in the Disclosure record using the error icon. Admins can configure when the validation step occurs in the workflow.
Creating a Submission File
Vault Disclosures allows you to generate a downloadable submission file of the Disclosure record for manual submission only for registries that support submission files by selecting Generate Disclosure XML.
Vault runs a validation check on the Disclosure record when you select Generate Disclosure XML. The Disclosure record must pass the validation check for users to generate the submission file. Vault uses the error icon to indicate which Disclosure record fields failed the validation check. Vault creates an error file in the Errors Found notification.
Once the Disclosure record passes the validation check, Vault creates the submission file in the Attachments section of the Disclosure Overview. Users can download the submission file and submit it to the appropriate registry. You can generate multiple versions of a Disclosure record submission file throughout the Disclosure Lifecycle, except in the Submitted workflow state. Admins can configure the Disclosure Lifecycle to edit the states where users can generate submission files.
Submitting a Disclosure Submission File
Vault supports the submission of US Disclosure records directly to ClinicalTrials.gov. The Generate and Submit action is available once an Admin configures a ClinicalTrials.gov connection. By default, the user action is only available for Disclosures in the Approved lifecycle state.
When you select Generate and Submit, **Vault attempts to submit the Disclosure submission file to ClinicalTrials.gov. Once Vault attempts to submit the Disclosure submission file, Vault displays a response status message and attaches a response XML file to the Disclosure record. The PRS Upload Results section in the Disclosure Overview layout shows all submission statuses and related attachments.
If the Disclosure submission is successful, Vault displays the “New Study created on PRS” status message.
Note: Once Vault successfully submits the Disclosure submission file, you must manually upload any related documents to ClinicalTrials.gov.
Vault will not submit the Disclosure XML file if the Disclosure record contains validation errors or the lifecycle locks the record from editing. Vault displays a status message to describe the reason for the failed submission attempt. To learn more about the specific error, click View Attachments on the status message. You can select Generate and Submit on the Disclosure record once you resolve the errors and resubmit the Disclosure submission file.
Admins can configure configure the Disclosure record lifecycle to edit the states where users can submit submission files.