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.

Configuration Overview

Configuring Disclosure Lifecycle 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

Disclosure Rules control the user actions that trigger Vault to create Disclosure records for supported registries.

Admins can change the Due Date Shift value on a rule to add additional days before the compliance due date and change the Status of any rule to Inactive for rules they do not want Veeva Disclosures to use. To configure Disclosure Rules, navigate to Admin > Configuration > Clinical Configurations > Disclosure Rules.

Mapping Custom Fields

To include custom fields on custom Disclosure XML files, an Admin must first create and add the field 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.

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 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 section of the Disclosure Overview to be posted to ClinicalTrials.gov.

Configuring the ClinicalTrial.gov Submission 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://prs.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.

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:

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