Vault automatically creates Disclosure records when changes trigger Disclosure Rules. Disclosure Rules store and use conditions for supported registry authorities (such as ClinicalTrials.gov and EU CTIS) to automatically notify users of changes to the site and study data related to key disclosure date updates and upcoming milestones that require disclosures.
Vault uses two types of Disclosure Rules: Scheduled and Event Based. Scheduled Disclosure Rules are triggered based on the Compliance Date listed on the Disclosure record while Event Based Disclosure Rules are triggered based upon the completion of an event.
Note: To allow for automatic US Disclosure creation for a Study, the Registration record associated with the Study and Authority must have a Disclosure Scope other than Not Disclosed. For US Studies, you must also set the Disclose Study on ClinicalTrials.gov field on the Study record to Yes.
When a Disclosure record is open and not yet submitted, Vault notifies the Disclosure Specialists of any of the changes below 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 user to the Disclosure Specialist role.
You cannot create new Disclosure Rules. However, you can view and configure the active rules by navigating to Admin > Configuration > Disclosure Rules.
Registration Record Auto-Creation
Vault automatically creates a Registration record before any Disclosure Rules trigger when you create a Study Country record for a Study:
- US: When you create a US Study Country record
- EU: When you create an EEA (European Economic Area) Study Country record
Note: When configured by an admin, Vault automatically creates a Registration record when you create a US Study Country record that an Admin has related to the appropriate US country code, or an EEA Study Country record related to the appropriate EEA (European Economic Area) Jurisdiction record.”
Disclosure Rules for US Protocol Registration Creation
Initial Registration
For studies where no Disclosure records exist, the first occurrence of any of the following changes will trigger the creation of a new Initial Protocol Registration record via Disclosure Rules:
Event-Based
- Site Activated Milestone has Date: A user enters or updates the Site Activated milestone Planned or Actual Finish Date.
- First Study Subject In Milestone has Date: A user enters or updates the First Study Subject In milestone Planned or Actual Finish Date.
- Last Study Subject Out Milestone has Date: A user enters or updates the Last Study Subject Out milestone Planned or Actual Finish Date.
- First Subject Screened Milestone has Date: A user enters or updates the First Subject Screened milestone Planned or Actual Finish Date.
- New Protocol Approved: When a user approves a new protocol record.
Registration Updates
A user must submit a Disclosure record before Vault automatically creates a Protocol Registration Update record. The following changes trigger the creation of a new Protocol Registration Update:
Scheduled
- Update Annually: 365 (Start Date Shift) days have passed since the Submitted Date of the latest US Protocol Registration disclosure.
Event-Based
- Individual Site Status Change: A user adds a new Study Site to a Study or changes the Site Recruitment Status of a Study Site.
- Site Activated Milestone Date is Updated: A user updates the Start Date for a Study Site.
- First Study Subject In Milestone Date is Updated: A user updates the First Study Subject In milestone Planned or Actual Finish Date.
- Last Study Subject Out Milestone Date is Updated: A user updates the Last Study Subject Out milestone Planned or Actual Finish Date.
- First Subject Screened Milestone Date is Updated: A user updates the First Subject Screened milestone Planned or Actual Finish Date. (inactive by default)
- Study Data Changed: A user changes the Study Start Date or Study Number for a Study.
- Enrollment Change: A user updates the Total Planned or Total Actual Enrollment for a Study.
- New Protocol Approved: When a user approves a new protocol record, Vault automatically creates a Protocol Registration Update Disclosure record by copying data from the initial registration or most recent registration.
Disclosure Rules for EU Application Creation
For European Union clinical trial applications, Vault automatically creates or updates Disclosure records based on the following changes:
Event-Based
Initial Application:
- New EEA Country Added: When a user creates a Study Country record located in the European Economic Area (EEA), Vault automatically creates an Initial Application Disclosure record (if none exists).
Application Updates:
- New Protocol Approved: When a user approves a new Protocol record, Vault automatically creates a Substantial Modification Disclosure record by copying data from the initial application or most recent substantial modification.
- New Country Added to Existing Trial: When a user adds a new EEA country to an active Study, Vault automatically creates an Additional Member State Concerned (MSC) Disclosure record by copying data from the initial application or latest modification.
Disclosure Rules for EU Notifications
Vault creates EU Notification disclosures when a user enters or updates the Planned Finish Date or Actual Finish Date on Country Milestone records in CTMS. If an open Notification Disclosure of that type already exists for the Study, Vault initiates a review workflow for the assigned Disclosure Specialist instead of creating a duplicate record.
Event-Based
- Recruitment Period Milestones: A user enters or updates the Planned Finish Date or Actual Finish Date for recruitment milestones (such as First Subject Screened) on a Study Country record.
- Trial Period Milestones: A user enters or updates the Planned Finish Date or Actual Finish Date for trial period milestones (such as First Subject In and Last Subject Out) on a Study Country record.
Disclosure Rules for US Results Creation
The following changes trigger the automatic creation of a new US Results record:
Scheduled
- 1 Year After Last Subject Out: 365 (Start Date Shift) days have passed since the Last Study Subject Out milestone Planned or Actual Finish Date.
- 1 Year After Primary Completion Milestone: 365 (Start Date Shift) days have passed since the Primary Completion Date milestone Planned or Actual Finish Date.
Disclosure Rules for EU Results Creation
Vault automatically creates EU Results disclosures based on the study completion date and whether the trial involves pediatric participants:
Scheduled
- 1 Year After Trial Completion: Vault creates an EU Results disclosure record 365 - Start Date Shift days after the Last Study Subject Out milestone completion date for non-pediatric studies.
- 6 Months After Trial Completion: Vault creates an EU Results disclosure record 180 - Start Date Shift days after the Last Study Subject Out milestone Planned or Actual Finish date when the Pediatric Trial field on the Study record is set to Yes.