**Source URL:** https://clinical.veevavault.help/en/lr/826042/index.md

# Using Disclosure Rules

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 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.


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      <p><strong>Note</strong>:  To allow for <a href="/en/lr/780440/#automatically-creating-disclosures">automatic</a> <em>US Disclosure</em> creation for a <em>Study</em>, you must select <strong>Yes</strong> for the <strong>Disclose Study on ClinicalTrials.gov</strong> field in the <em>ClinicalTrials.gov Disclosure</em> section on the <em>Study</em> record and select either <strong>Registration only</strong> or <strong>Registration and Results</strong> for the <em>Disclosure Scope</em> on the <a href="/en/lr/899718/#creating-registrations"><em>Registration</em> record</a>.</p>
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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. 

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      <p><strong>Important</strong>: An error occurs when <em>Disclosure Rules</em> trigger the creation of a <em>Disclosure</em> 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.</p>
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You cannot create new _Disclosure Rules_. However, you can view and [configure](/en/lr/793399/) 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_:

### 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_.

## 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_:

### Scheduled
* **Update Annually**: 335 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_.
* **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_.

## 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**: 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_.