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 Protocol Registration Creation
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.
Disclosure Rules for Protocol Registration Update Creation
A user must submit a Disclosure record before Vault will automatically create a Protocol Registration Update disclosure. The following changes trigger the creation of a new Protocol Registration Update 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.
- 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 disclosure:
- 335 days have passed since the Last Study Subject Out milestone Finish Date.
- 335 days have passed since the Primary Completion Date milestone Finish Date.