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 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.
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 custom 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 selected Study populate this field as options.
- Select the Study Design Type from the drop-down menu.
- 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 Rules. 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.
The following changes trigger the automatic creation of a new Initial Protocol Registration Disclosure record via Disclosure Rules:
- A user updates the Site Activated milestone Finish Date field for the first time.
- A user plans the First Study Subject In milestone Finish Date for the first time.
- A user plans the Last Study Subject In milestone Finish Date for the first time.
The following changes trigger the automatic creation of a new Disclosure Protocol Registration Update record, provided that a user submitted a previous Disclosure:
- A user adds a new Study Site to a Study record.
- A user updates The Start Date for a Study Site.
- A user updates the First Study Subject In milestone date for a study.
- A user updates the Last Study Subject In milestone date for a study.
- A user changes the Start Date for a Study record.
- A user changes the Study Number for a Study record.
- A user changes the Site Recruitment Status of a Study Site record.
- A user updates the Total Planned Enrollment for a Study record.
If a Disclosure record is open and not yet submitted, Vault notifies Disclosure Specialists of any of the above changes and assigns them a task to review the Disclosure.
Important: An error occurs when Disclosure Rules trigger the creation of a Disclosure record and no Disclosure Specialists are defined within Vault. To avoid these errors, Admins must assign at least one (1) user to the Disclosure Specialist role.
Disclosure Records
Vault Disclosures separates Disclosure records into two tabs: a Disclosure Overview tab and a Disclosure Form tab. To navigate between tabs, use the drop-down menu to the left of the screen.
Disclosure Overview
All Disclosure records include the Disclosure Overview tab, which includes the Details, Related Documents, Attachments, Workflow Timeline, and System Details sections. These sections allow you to add disclosure details unrelated to a specific registry.
The Details section of the Disclosure record shows the information used by Vault or a user to create the record. 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.
In the Related Document section, you can add and view any Vault documents related to the disclosure. Vault Disclosures displays documents linked in this section in the Related Documents section of the Disclosure Form for supported registry records. Click the Add button in the upper left corner of the Related Documents section to link new documents. 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. Select the Generate Disclosure XML option from the All Actions menu to create a Disclosure record submission file.
The System Details section provides information about the creation, editing, and lifecycle state of the Disclosure record. This section automatically displays the Last Modified Date and Last Modified By fields, which reference the latest modification of the Disclosure Overview tab. The Disclosure Overview layout does not automatically display the Content Last Modified Date and Content Last Modified By fields, which reference the latest modification of the Disclosure Form tab. Admins must configure the Disclosure Overview page layout to include the Content Last Modified Date and Content Last Modified By fields.
Disclosure Form
Note: Only users with a layout profile inluding Disclosures can view the Disclosure Form object section on Disclosure records.
The Disclosure Form tab is only available for supported registry Disclosure records and allows you to add additional information needed for specific registry submissions.
For example, for US registration, the Disclosure Form tab includes the Study Details, Study Plan, More Info, and Documents. These sections will vary per registry and disclosure type. The Study Details, Study Plan, and More Info sections in a US Protocol Registration allow you to add additional information to the US Disclosure Form record.
Vault pre-populates fields in the Disclosure Form record when the disclosure is created. Vault Disclosures does not update the section fields when users update associated CTMS objects.
The Documents section displays all linked Vault documents related to the disclosure for Disclosure Reviewers to view when reviewing the record. You can access linked documents in this section. To link new Vault documents, you must navigate to the Related Documents section of the Disclosure Overview tab.
Data Pre-population
Vault Disclosures utilizes CTMS, eTMF, and Study Startup Vaults shared objects to pre-populate fields within the Disclosure Form of the Disclosure records. These pre-populated fields ensure that data is consistent across objects during the disclosure process for manually and automatically created Disclosure records.
Note: Vault pre-populates fields on the Disclosure Form when a user or Vault creates the Disclosure record. Once the record is created, the pre-populated fields remain unchanged unless manually updated, even if the original CTMS data changes.
Vault pre-populates specific Disclosure Form fields with values from CTMS fields based on the selected Study record or its related Metric record. The table below lists the pre-populated Disclosure Form fields and the CTMS field the data populates from. For example, Vault will populate the Protocol Identification Number field using the value from the Study Number field on the selected Study record.
| CTMS Object | CTMS Field | Pre-populated US Disclosures Field |
|---|---|---|
| Study | Study Number | Protocol Identification Number |
| Study | Protocol Title | Official Title |
| Study | Study Design Type | Study Type |
| Study | Study Start Date | Study Start Date |
| Metrics | Planned Total Enrollment | Enrollment |
Site List
Vault populates the Site List section with Study Sites data from the selected Study. The Study Sites data is not editable in the Site List section. You can locate the Site List in the More Info section of the Disclosure Form.
Study Sites populate into the Site List based on the sites marked as Include for Disclosure. Vault automatically selects the Include in Disclosures checkbox on all new Study Site objects. To have a Study Site populate into the Disclosure record, ensure the Include in Disclosures checkbox is selected while creating or editing a Study Site.
Principal Investigator data for disclosed Study Sites also populates into the Site List. Unlike Study Sites, Vault does not automatically select the Include in Disclosure checkbox on the Study Person record for the selected Principal Investigator. Select the Include in Disclosures checkbox when editing the Study Person record for the Principal Investigator to ensure Vault populates the data in the Disclosure record.
Vault populates the Site List section from CTMS records. The following table lists the populated Disclosure Form record fields and the CTMS object and fields from which the data populates:
| CTMS Object | CTMS Field | Pre-populated US Disclosures Field |
|---|---|---|
| Study Site | Site ID | Site ID |
| Study Site | Recruitment Status | Site Status |
| Organization | Name | Study Site Name |
| Primary Study Site Location | Town/City | Town/City |
| Primary Study Site Location | State/Providence/Region | State/Providence/Region |
| Primary Study Site Location | Postal/Zip Code | Postal/Zip Code |
| Primary Study Site Location | Country | Country |
| Principal Investigator Study Person | First Name | First Name |
| Principal Investigator Study Person | Last Name | Last Name |
| Principal Investigator Contact Info | Phone Number | Phone Number |
| Principal Investigator Contact Info |
Validation
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. A Disclosure record cannot move to the Approved state of the workflow until it passes the validation checks. 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 XML submission files. Select the Generate Disclosure XML option from the All Actions menu to create the Disclosure record submission file.
When you select Generate Disclosure XML, Vault runs a validation check on the Disclosure record. 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. If additional errors are found, Vault creates an error file you can access in the Errors Found notification.
Once the Disclosure record passes the validation check, Vault creates the submission file for download and saves the file to the Attachments section in the Disclosure Overview. Users can download the submission file from the Attachments section to manually submit the file to the appropriate registry. You can generate multiple versions of a Disclosure record submission file throughout the Disclosure record workflow, except in the Submitted workflow state. Admins can configure the Disclosure record workflow to edit the states in which users can generate submission files.