Vault Disclosures gives sponsors the ability 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 are required to register study trials globally and make study disclosures throughout the study. In Vault Disclosures, you can create new disclosures from both 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 either the Disclosures tab or to 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. Vault pre-populates the Study field with the selected study when you create a new Disclosure record from the Disclosure section of the Study.
- Select the Authority from the drop-down menu. The selected Authority determines the available options for the Disclosure Type and Disclosure Version fields.
- Select the Disclosure Type from the drop-down menu. The selected Disclosure Type determines the available 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 record pre-populate as options for this field.
- Select the Study Design Type from the drop-down menu.
- Optional: Enter a Comment. This field can be used 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.
Note: US Disclosures records also contain a Disclosure Form section where you can add additional data by disclosure type. Only users with a layout profile including Disclosures can view the Disclosure Form related object section on Disclosure records.
Automatic Disclosure Creation
In addition to creating new Disclosure records manually, Vault can automatically create Disclosure records using Disclosure Rules. Disclosure Rules store and utilize conditions by registry authority 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 Disclosure Rules from Admin > Configuration > Disclosure Rules.
Note: Vault Disclosures currently only creates automatic Disclosure records for US protocol registration.
The following changes trigger the automatic creation of a new 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 update Disclosure record, provided that a previous Disclosure has been submitted:
- 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.
When users make the above changes, the following behaviors trigger within Vault Disclosures:
- If a Disclosure record was never created for the study, Vault creates a new US Initial Protocol Registration.
- If a Disclosure Specialist already submitted the Disclosure record, Vault creates a new US Protocol Update. A Disclosure update creates a copy of the latest submitted disclosure.
- If an open Disclosure record already exists, Vault notifies Disclosure Specialists that new changes have occurred and assigns them a task to review the Disclosure.
Important: An error occurs when Disclosure Rules trigger the creation of a Disclosure record and there are no Disclosure Specialists defined within Vault. To avoid these errors, Admins must assign at least one (1) user to the Disclosure Specialist role.
Data Pre-population
Vault Disclosures utilizes the shared object with CTMS, eTMF, and Study Startup Vaults to pre-populate fields within the Disclosure records. These pre-populated fields ensure that data is consistent across objects during the disclosure process for both manually and automatically created Disclosure records.
Note: Vault only pre-populates fields on the Disclosure record once when it’s created. After that, they remain unchanged unless manually updated, even if the original CTMS data changes.
Vault pre-populates specific Disclosure record 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 record fields and the CTMS field the data populates from. For example, Vault may populate the Protocol Identification Number field with the same value as that of 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
The Site List is available in the More Info section of the Disclosure Form. Site List is the only non-editable section on Disclosures. Instead, Vault automatically populates it with the Study Sites listed within the selected Study.
Note: Study Sites populate into the Disclosures object based upon the sites approved for disclosure. To have a Study Site and its associated data populate in the Disclosure record, ensure the Include in Disclosures checkbox is checked when creating or editing the Study Site.
Vault pre-populates the following CTMS data on the Disclosure record based on disclosed Study Sites:
- The Site ID field populates from the Site ID field on the Study Site object.
- The Site Status field populates from the Recruitment Status field on the Study Site object.
- The Study Site Name field populates with the Name field from the Organization object.
- The primary Study Site Location object populates the Town/City, State/Providence/Region, Postal/Zip Code, and Country fields.
- The Study Person object and Contact Info object for the primary investigator populate the First Name, Last Name, Phone Number, and Email fields.