**Source URL:** https://clinical.veevavault.help/en/lr/793399/index.md

# Configuring Disclosures

Veeva Disclosures allows you to create and edit _Disclosure_ records to store and manage information for clinical trial disclosures, and generate disclosure submission files for supported registries. You can use Veeva Disclosures upon deployment; however, Admins can configure the application to reflect their company's processes.

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      <p><strong>Note</strong>: 
Veeva Support must enable Veeva Disclosures in your Vault. Veeva Disclosures is an add-on application to Vault <a href="/en/lr/40009/">CTMS</a> and is a part of the <a href="/en/lr/44699/">Clinical Operations</a> application family. You must have Veeva CTMS and <a href="/en/lr/4660/">Veeva eTMF</a> to use Veeva Disclosures. Contact your Veeva representative for more information.</p>
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## Configuration Overview
* Add the **Content Last Modified By** and **Content Last Modified** fields to the _Disclosure Overview_ page layout.
* Add the **Disclosures**, **Protocols**, and **Registrations** sections to the _Study_ page layout.
* Add the [**Unlock XML** and **Lock XML** entry actions][1] to the appropriate _Disclosure Lifecycle_ lifecycle states.
* Optional: Configure the [**Validate Disclosure**](/en/lr/793399/#entry-actions) entry action on the _Disclosure Lifecycle_.
* Configure a workflow for the _Disclosure Lifecycle_. This Vault validation creates a CSV of errors, which differs from the user-facing, US-only _Validate_ action that displays errors on-screen.
* Optional: Configure [**Disclosure Rules**][2] to trigger _Disclosure_ record creation.
* Optional: [Map custom fields][3] for custom _Disclosure_ XML files.
* [Map document types][4] to add related documents to _Disclosure_ records.
* Optional: Configure the **Download Formatted Output** user action on the appropriate _Disclosure Lifecycle_ states.
* Optional: Configure the [**Generate Document from Formatted Output**](/en/lr/793399/#document-generation-action) entry action and user action on the appropriate _Disclosure Lifecycle_ states.
* Configure the [connection to ClinicalTrials.gov Protocol Registration and Results System (PRS)][5].
* Optional: Configure the **Validate** user action on the appropriate _Disclosure Lifecycle_ states.
* Optional: Configure the _Validate_ connection to ClinicalTrials.gov Protocol Registration and Results System (PRS) Test for use by the _Validate_ action.
* Configure a [workflow](/en/lr/33553/) or an action trigger to create a task to review the ClinicalTrials.gov comments once they are posted.
* Optional: Import disclosure records for existing Studies from ClinicalTrials.gov.
* Optional: Inactivate custom values on the _Protocol_ object's **Study Phase** (`study_phase__v`) picklist and activate the following standard values:
  * _N/A (Not Applicable)_ (`na__v`)
  * _Early Phase I_ (`early_phase_1__v`)
  * _Phase I_ (`phase_1__v`)
  * _Phase I/II/III_ (`phase_1_2_3__v`)
  * _Phase I/II_ (`phase_1_phase_2__v`)
  * _Phase I/III_ (`phase_1_3__v`)
  * _Phase Ia_ (`phase_1a__v`)
  * _Phase Ib_ (`phase_1b__v`)
  * _Phase II_ (`phase_2__v`)
  * _Phase II/III_ (`phase_2_phase_3__v`)
  * _Phase IIa_ (`phase_2a__v`)
  * _Phase IIb_ (`phase_2b__v`)
  * _Phase III_ (`phase_3__v`)
  * _Phase IIIa_ (`phase_3a__v`)
  * _Phase IIIb_ (`phase_3b__v`)
  * _Phase IV_ (`phase_4__v`)
  * _Phase V_ (`phase_5__v`)

##  Configuring Disclosure Lifecycle Entry Actions {#entry-actions}
The _Disclosure Lifecycle_ has three unique entry actions: _Unlock XML_, _Lock XML_, and _Validate Disclosure_.

The _Unlock XML_ and _Lock XML_ entry actions enable and disable the _Generate Disclosure XML_ user action. The _Validate Disclosure_ entry action runs a validation check on the _Disclosure_ record to ensure all supported registry validations are resolved before entering the lifecycle state. 

Admins can add the **Unlock XML**, **Lock XML**, and **Validate Disclosure** entry actions to _Disclosure Lifecycle_ lifecycle states.

##  Configuring Disclosure Rules {#config-disclosure-rules}
[_Disclosure Rules_](/en/lr/826042/) control the user actions that trigger Vault to create Disclosure records for supported registries. To configure **Disclosure Rules**, navigate to **Admin > Configuration > Clinical Configurations > Disclosure Rules**.

Admins can change the **Due Date Shift** and **Start Date Shift** value on _Disclosure Rule_ to allow Vault to trigger the rule  prior to the _Compliance Date_ on the Disclosure record. The Due Date Shift determines the number of days or months prior to the Compliance Date that the Disclosure update is due. The Start Date Shift determines the number of days or months prior to the Compliance Date that the Disclosure update should begin. Admin can also change the **Date Shift Units** to either days or months. The Date Shift Units value applies to both the Due Date Shift and Start Date Shift. 

Admins can change the **Status** of any rule to _Inactive_ for rules they do not want to use.

## Mapping Custom Fields {#mapping-custom-fields}
To include custom fields on custom _Disclosure_ XML files, an Admin must first [create and add the field](/en/lr/15057/#how_to_add_object_fields) to the _Disclosure Overview_ page layout of the _Disclosure_ object. Once the field exists on the _Disclosure Overview_ page layout, an Admin must map the field to include it on the custom _Disclosure_ XML. 

To map custom fields for custom _Disclosure_ XML files:

1. Navigate to **Admin > Configuration > Disclosure XML Field Mappings**. 
2. Click **Create**. 
3. Enter a **Name** for the custom field. The _Name_ can only include lowercase letters, numbers, and one consecutive underscore. The _Name_ cannot begin or end with an underscore. For example, `therapeutic_area`.  
4. Select **Disclosure** in the _Object_ field. 
5. In _Field_, enter the **Field Name** for the field added to the _Disclosure Overview_ page layout. You must precede the _Field Name_ with `Field.`. For example, `Field.theraputic_area__c`. 
6. Enter an **XML Field Name**. Vault displays the _XML Field Name_ as the label for the field in the custom _Disclosure_ XML file. 
7. Click **Save**. 

Once mapped, Vault includes the _Generate Disclosure Custom XML_ action on _Disclosure_ records. When you run the **Generate Disclosure Custom XML** action, Vault displays the custom field on the custom _Disclosure_ XML file. Vault does not include custom fields on the _Disclosure_ submission file sent to supported registries or the _Disclosure_ XML file generated by running the _Generate Disclosure XML_ action.

## Mapping Related Documents {#mapping-related-documents}
For users to post _Related Documents_ associated with a _Disclosure_ record to ClinicalTrials.gov, configure and map the document types that users can select. An Admin must add the _Disclosure_ (`disclosure__v`) [shared field to the document type](/en/lr/4884/#use-shared-field) and then map the document type for the _Disclosure_ object. 

To map document types for the _Disclosures_ object:

1. Navigate to **Admin > Configuration > Disclosure XML Doctype Mappings**. 
2. Click **Create**. 
3. Add a **Name** for the document type mapping. The _Name_ can only include lowercase letters, numbers, and one consecutive underscore. The _Name_ cannot begin or end with an underscore. For example, `protocol_mapping`.
4. Select an **eTMF Document Type**.
5. Select the **ClinicalTrials.gov Document Type**. This specifies how Vault classifies _Related Documents_ of this _eTMF Document Type_ when the system submits the document to ClinicalTrials.gov via the submission connection. 
6. Click **Save**. 

Once configured, you can select documents in the [_Related Documents_](/en/lr/780440/#related-documents-section) section of the _Disclosure Overview_ to be posted to ClinicalTrials.gov.

## Configuring the ClinicalTrial.gov Submission Connection {#clinicaltrials-connection}

Vault supports the submission of _US Disclosure_ records directly to ClinicalTrials.gov Protocol Registration and Results System (PRS). _US Disclosures_ will have the _Generate and Submit_ action in the _All Actions_ menu once an Admin configures the ClinicalTrials.gov PRS connection. 

To configure the connection to ClinicalTrials.gov PRS:

1. Navigate to **Admin > Connections**.
2. Select **Create** and select **External** from the dropdown list.
3. Enter the **Name**.
4. Enter the **API Name**.
5. Enter the **URL** for the ClinicalTrials.gov website. For a test connection, enter the **https://prstest.clinicaltrials.gov** URL. For a production connection, enter the **https://register.clinicaltrials.gov** URL. 
6. Click into the **Authorization** field and select **Create Connection Authorization**.
7. Select **Basic Auth** from the dropdown list. 
8. In the _Create Basic Auth_, enter any **Name** for the _Connection Authorization_. 
9. Enter your ClinicalTrials.gov **Username** in the _Username_ field. 
10. Select **Save**. 
11. Open the _All Actions_ menu for the _Basic Auth_ and select **Set Password.** 
12. Enter your ClinicalTrials.gov **Password**.
13. Select **Save** for _Set Password_. 
14. Enter the **Organization Name** associated with your ClinicalTrials.gov PRS account. If you do not see the _Organization Name_ field, add the **Organization Name** field to the page layout.
15. Select **Save** for _External Connection_. 

Once you configure the ClinicalTrial.gov connection, you can select the **Generate and Submit** user action on US Disclosures in the _Approved_ state to submit the Disclosure.

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      <p><strong>Important</strong>: To use the <em>Validate</em> action, you must configure both the test and production connections to ClinicalTrials.gov Protocol Registration and Results System (PRS).</p>
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## Importing Existing Study Disclosure Records

In Vaults with the ClinicalTrial.gov Submission Connection configured, an Admin can import existing Studies and the related data. To import existing Study data from ClinicalTrials.gov, navigate to **Admin > Connections** and select the **Import Existing Studies** user action from the _All Action Menu_ on the _ClinicalTrial.gov_ connection. Selecting this user action open

To import existing Study disclosure data from the ClinicalTrials.gov connection:

1. Navigate to **Admin > Connections**.
2. Click the **All Actions Menu** to the right of your Vault's ClinicalTrials.gov connection _Name_ field. 
3. Select the **Import Existing Studies** user action. 
4. In the _Import Existing Studies_ dialog, enter a **Completed Date**. The date can be no earlier than two years prior to today. This is the date the submission was completed on or after. 
5. Click **Import**.

Once you click **Import**, the system automatically creates _Registration_ and _Disclosure_ records for all Studies with matching _Study_ records in your Vault that do not have those existing records. 

## Configuring the Document Generation Action {#document-generation-action}
You must configure the _Generate Document From Formatted Output_ action as a user or entry action on any applicable _Disclosure_ lifecycle state. 

While the configured action automatically determines a document _Owner_, you can use DAC to grant access to other roles as necessary. 

1. Navigate to the _User Actions_ or _Entry Actions_ section of the applicable _Disclosure_ lifecycle state details page and click **Edit**.
2. Select **Always** or **Perform with conditions** as appropriate for your process. 
3. Select the **Generate Document From Formatted Output** action from the drop-down.
4. Select the **Print Disclosure** formatted output from the _Formatted Output Template_ drop-down.
5. Select a **Document Type**. You can choose from any document type in your Vault. We recommend creating a dedicated document type for _Disclosure_ records.
6. Select a **Document Lifecycle** for the document type.
7. Select a **Document Field On Object**. The selection is limited to outbound document reference fields available on the object.  After the action executes, Vault populates this field with a link to the newly generated document.
8. Enter an **Action Label**. This is only required for user actions. 
9. Click **Save**.

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      <p><strong>Note</strong>: Users must be in a document role that grants <em>View Document</em> permission for the selected <em>Document Type</em> to see the configured action on the <em>Disclosure</em> object.</p>
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Once configured, users can generate the _Disclosure_ document so that it can be routed for review, saved to eTMF, or cross-linked into RIM.

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      <p><strong>Note</strong>: When the <em>Generate Document From Formatted Output</em> action runs, if the target object already has a document referenced in the specified <em>Document Field On Object</em> field, Vault generates a new version of the existing document. If the associated formatted output template has a different document output format than the existing document, Vault updates the format on the new document version.</p>
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## Related Permissions
You can complete all steps in this article with the standard Business Admin, System Admin, or Vault Owner profile. The following permissions control the ability to configure Veeva Disclosures components within Vault. If your Vault uses custom security profiles, your profile must have the following [permissions](/en/lr/22824/): 

| Permission Type | Permission | Controls    |
| --------------- | ---------- | ----------- |
| Security Profile | Admin: Object Lifecycles: Read, Edit | Ability to configure the _Disclosure Lifecycle_ and the _Unlock XML_, _Lock XML_, and _Validate Disclosure_ entry actions |
| Security Profile | Object: Disclosures: Create, Edit, Delete | Ability to create, update, and delete _Disclosure_ records and the _Disclosure_ page layouts |
| Security Profile | Admin: Object Workflows: Read, Create, Edit | Ability to view, create, and configure object workflows |
| Security Profile | Admin: Disclosure Rules: Read, Edit | Ability to view _Disclosure Rules_ |
| Security Profile | Application: API: Metadata API | Ability to edit _Disclosure Rules_ |
| Security Profile | Application: Manage Connections | Ability to view and configure Connections|
| Security Profile | Admin: Configuration: Document Types: Read, Create, Edit | Ability to view, create, and configure document types.|

[1]: #entry-actions
[2]: #config-disclosure-rules
[3]: #mapping-custom-fields
[4]: #mapping-related-documents
[5]: #clinicaltrials-connection