Vault automatically creates Disclosure records when changes trigger Disclosure Rules. Disclosure Rules store and use conditions for supported registry authorities to automatically notify users of changes to the CTMS site and study data related to key disclosure date updates and upcoming milestones that require disclosures.
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.
Disclosure Rules for Initial US Protocol Registration Creation
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:
- 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.
Disclosure Rules for US Protocol Registration Update Creation
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:
- 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.
- 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.
- Update Annually: 335 days have passed since the Submitted Date of the latest US Protocol Registration disclosure.
Disclosure Rules for US Results Disclosure Creation
The following changes trigger the automatic creation of a new US Results record:
- 1 Year After Last Subject Out: 335 days have passed since the Last Study Subject Out milestone Planned or Actual Finish Date.
- 1 Year After Primary Completion Milestone: 335 days have passed since the Primary Completion Date milestone Planned or Actual Finish Date.