# Using Disclosures Veeva Disclosures allows sponsors to centralize and streamline the clinical disclosure management process by accelerating registry submissions and improving compliance across global regulations.
## About Disclosure Records Veeva Disclosures separates _Disclosure_ records into two layouts: _Disclosure Overview_ and _Disclosure Form_. To navigate between layouts, use the layout picker drop-down menu to the left of the page. Disclosure Record Layout Picker ### Disclosure Overview Layout All _Disclosure_ records include the _Disclosure Overview_ layout. The layout displays the information you or the system used to create the _Disclosure_ record in the _Details_ section. The system generates a _Compliance Date_ based on the [_Disclosure Rule_](/en/lr/826042/) that triggers the creation of a new _Disclosure_ record. The _Compliance Date_ is a read-only field and displays the date the disclosure is due according to registry requirements. You can enter a **Due Date** when editing the _Disclosure_ record. The _Due Date_ field represents an internal date defined by your company processes in order to meet the registry required _Compliance Date_. When you submit the _Disclosure_ record, we recommend you update the **Submission Date**. Vault updates the _Submission Date_ for all _Disclosure_ records submitted via the [ClinicalTrials.gov submission connection](/en/lr/793399/#clinicaltrials-connection). #### Related Documents {#related-documents-section} When [configured](/en/lr/793399/#mapping-custom-fields), you can [add documents][7] to _Disclosure_ records in the _Related Documents_ section of the _Disclosure Overview_. You can view documents linked to the _Disclosure_ both in this section and the _Related Documents_ section of the _Disclosure Form_, if available. Once added, you can also submit the documents to ClinicalTrials.gov with the [ClinicalTrial.gov submission connection](/en/lr/793399/#clinicaltrials-connection) by selecting the _Post/Update Documents_ user action. #### Attachments Vault links all generated versions of the [_Disclosure_][5] and API responses from [submitting the _Disclosure_ record][6] in the _Attachments_ section. Select the files in this section to view and download them. ### Disclosure Form Layout
The _Disclosure Form_ layout is only available for supported registry _Disclosure_ records and allows you to add the information required for specific registry submissions. The available sections will vary per registry and [disclosure type](/en/lr/780439/#disclosure-type). When you or Vault create a _Disclosure_ record, Vault [prepopulates specific fields][6] in the _Disclosure Form_ layout. Vault does not update the data in the prepopulated fields when Vault or a user updates the associated Clinical Operations objects. While Vault does not update prepopulated fields, you can [check for updates][4] to the data that Vault uses to prepopulate the fields. ## Creating Disclosures {#creating-disclosures} Vault supports the manual and automatic creation of _Disclosure_ records. Vault automatically creates _Disclosure_ records when a user triggers an active [_Disclosure Rule_](/en/lr/826042/). All _Disclosure_ records, whether created manually or automatically, require a _Registration_ record. You can [create _Registration_ records](/en/lr/899718/#creating-registrations) before or during the _Disclosure_ record creation process. ### Manually Creating Disclosures Sponsors must register study trials globally and make study disclosures throughout the duration of the study. To create a new **Disclosure** record: 1. Navigate to the **Disclosures** tab or the **Disclosures** section of the _Study_ record you want to disclose. 2. Click **Create**. 3. Enter the **Disclosure Name**. 4. Search for and select a **Study**. When you create a new _Disclosure_ record from the _Disclosure_ section of a _Study_ record, Vault populates the _Study_ field with the selected _Study_. 5. Select the **Authority** from the drop-down menu. The _Authority_ determines the available options for the _Disclosure Type_ and _Disclosure Version_ fields. 6. Select the **Disclosure Type** from the drop-down menu. The _Disclosure Type_ determines the available options for the _Disclosure Subtype_ and _Disclosure Version_ fields. 7. Select the **Disclosure Subtype** from the drop-down menu. 8. Select the **Disclosure Version** from the drop-down menu. 9. Optional: Select a [**Protocol**](/en/lr/899718/#protocol) record. 10. Optional: Enter a **Due Date**. 11. Optional: Search for and select a **Study Country**. Vault only displays the countries in the selected _Study_ record. 12. Select the **Study Design Type** from the drop-down menu. If left blank, this field populates with the _Study_'s _Design Type_. 13. Optional: Enter a **Comment**. Users can use this field to comment on the _Disclosure_ during the review process or to leave other comments about the _Disclosure_. 14. Select a **Registration** record. If no _Registration_ record exists for your desired study and authority, [create a **Registration** record](/en/lr/899718/#creating-registrations). 15. Click **Save**. Creating a new _Disclosure_ record completes the _Disclosure Overview_ section of the record. To continue editing and adding data to the *Disclosure* record, navigate to the **Disclosure** tab, open the _Disclosure_ record you created, and click **Edit**. ### Automatically Creating Disclosures {#automatically-creating-disclosures} Vault automatically creates _Disclosure_ records using [_Disclosure Rules_](/en/lr/826042/). *Disclosure Rules* store and use conditions for supported registry authorities to automatically notify users of changes to _Site_ records and study data related to key disclosure dates and upcoming milestones that require disclosure. Vault saves the _Disclosure Rule_ label in the _Reason Created_ field on the _Disclosure_ record. Admins can view and [configure](/en/lr/793399/) _Disclosure Rules_ by navigating to **Admin \> Configuration \> Disclosure Rules**.
## Using Disclosure Data Prepopulation Veeva Disclosures utilizes CTMS, eTMF, and Study Startup Vaults shared objects to [prepopulate fields](/en/lr/826043/) within the _Disclosure Form_ layout of _Disclosure_ records. These prepopulated fields ensure data is consistent across objects during the disclosure process for manually and automatically created _Disclosure_ records.
### Updating Prepopulated Disclosure Fields {#updating-disclosure-form-fields} When you or Vault create a _Disclosure_ record, Vault prepopulates specific fields in the _Disclosure Form_ layout with data from associated Clinical Operations object records. When the system or a user updates the data in one of these records, Vault does not update the data in the prepopulated fields. To check for updates to the data corresponding to the prepopulated fields, click the **Check for Updates** button in the _Disclosure Form_. Disclosure Prepopulated Fields Icon When you click the **Check for Updates** button, Vault opens a _Check for Updates_ page in a new tab. This page displays one column with all the current _Disclosure Version_ data and one column with the _Newer Version_ data. The page includes sections for each Clinical Operations object within the Disclosure sections with any updated data that does not match the existing data in the associated prepopulated _Disclosure Form_ field with the _Source_ object and the date it was most recently updated in the column header.  The _Check for Updates_ page is view-only. To include the most recent data in your _Disclosure Form_, you must manually update the prepopulated fields with the most recent information. Once the data for all the prepopulated fields corresponding to a single Clinical Operations object match the data in the object, that section is no longer displayed on the _Check for Updates_ page once refreshed. Disclosure Check fo Updates Page ## Commenting on Disclosures The _Add a comment_ icon on the Disclosure Form subsections allows users with the correct permissions to add, _Edit_, _Delete_, _Resolve_, and _Reopen_ comments on the _Disclosure_ record. Users with _View_ permissions, such as Disclosure Reviewers and Specialists, can add, _Edit_, _Delete_, _Resolve_, and _Reopen_ your own comments. In addition to managing your own comments, Disclosure Specialists can also view, _Resolve,_ and _Reopen_ all comments left on the record by any users. You can only edit or delete your own comments. Once you delete your comment, you can not retrieve it.  Vault displays an orange _Unresolved_ comments icon in the header and side navigation for each subsection with open comments. A subsection can have a maximum of 100 open comments and 200 comments in total, including resolved comments. When all comments for a subsection are resolved, Vault displays a green _Resolved_ comments icon.  In configured _Disclosure_ lifecycles, you can not move a _Disclosure_ record with open comments to the _Approved_ state. ## Editing Disclosures After you or Vault create a _Disclosure_ record of any type, you can make changes to the record during any unlocked lifecycle stage prior to submission. ### Populating US Results Tables When editing a _US Results_ type _Disclosure_ record, click the **Fill Arm/Group from Registration** button in the _Arms/Groups_ section header to populate the _Arm/Group Information_ table. Click the **Fill Outcome Measures from Registration** button in the _Define Outcome Measures_ section header to populate the different Outcome Measure tables. Vault only displays these buttons when the corresponding table is empty.  The _Fill Arm/Group from Registration_ and _Fill Outcome Measures from Registration_ buttons populates these tables with the data from the most recently submitted _Registration_ record associated with the _Study_. When multiple Registration records exist for the Study associated with the _US Results_ record, Vault uses the _Registration_ record in the _Approved_ or _Submitted_ lifecycle state with the most recent _Submission Date_ value. When no record with a submission date exists, Vault uses the _Registration_ record with the most recent _Last Content Modified Date_. ### Reordering Arm/Group Tables for US Results Select **Move Up** or **Move Down** in the _Action Menu_ to the right of the _Arm/Group Title_ field to reorder the existing rows in the _Arms/Groups_ subsection. Once you reorder the rows and click **Save and Proceed**, Vault reorders the columns of corresponding tables in the _Disclosure_ record. ### Copying US Results Table Rows You can copy rows in the _Outcome Measures_ and _Adverse Event tables_ by navigating to the row in the table and clicking the **Action** menu to the right of the first cell in the row and selecting the **Copy Row** action. This action duplicates the row in the table directly below the selected row. You can update and make changes to the rows in the table. Once done, click **Save and Proceed** to save changes and update corresponding tables with the new information.  ### Importing Adverse Events for US Results Selecting the **Import Results XML** user action allows you to upload a file containing data that Vault populates into the _Adverse Events Reporting_ section of the _US Results_ type _Disclosure_ record. Select **Upload and Overwrite** to confirm that you want the data on the uploaded file to overwrite any existing data in the section. Vault displays an error message and notifies you if any errors occur with the uploaded XML file. Once you successfully upload the new file, refresh your page to view the imported data. ## Validating Disclosures By default, Vault validates _Disclosure_ records for supported registries when users move them to the _Approved_ state. Vault runs specific validation checks based on the selected supported registry. Vault indicates validation errors in the _Disclosure_ record using the error icon, or in an error file generated at validation. Admins can configure when the validation step occurs in the [workflow](/en/lr/33498/). ## Generating Disclosure Submission Files {#creating-disclosure-file} Veeva Disclosures allows you to generate a downloadable submission file of the _Disclosure_ record for manual submission to supported registries by selecting **Generate Disclosure XML**. Vault runs a validation check on the _Disclosure_ record when you select **Generate Disclosure XML**. The _Disclosure_ record must pass the validation check for users to generate the submission file. Vault uses the error icon to indicate which _Disclosure_ record fields failed the validation check. Vault creates an error file in the _Errors Found_ notification. Once the _Disclosure_ record passes the validation check, Vault creates the submission file in the _Attachments_ section of the _Disclosure Overview_. Users can download the submission file and submit it to the appropriate registry. You can view previous versions of the submission file in the attachment's [version history](/en/lr/58613/#working-with-attachments). You can generate multiple versions of a _Disclosure_ record submission file throughout the _Disclosure Lifecycle_, except in the _Submitted_ workflow state. Admins can configure the _Disclosure_ _Lifecycle_ to edit the states where users can generate submission files. ### Generating Custom Disclosure Files Admins can [configure custom fields](/en/lr/793399/#mapping-custom-fields) for the _Disclosure object to include on custom Disclosure XML files_. Once configured, these fields appear in the _Disclosure Overview_ section of the _Disclosure_ record. These custom fields do not appear on _Disclosure_ submission files sent to supported registries or generated by the _Generate Disclosure XML_ action. To include custom fields on _Disclosure_ submission files, select **Generate Disclosure Custom XML**. Vault provides the newly generated custom _Disclosure_ XML file attachment in the _Custom XML_ field in the _Disclosure Overview_ section of the _Disclosure_ record to be downloaded. This file can support processes to publish study information to custom public websites. ## Submitting a Disclosure to ClinicalTrials.gov {#submitting-disclosure-file} Vault supports the submission of US _Disclosure_ records directly to ClinicalTrials.gov. The _Generate and Submit_ action is available once an Admin configures a [ClinicalTrials.gov connection](/en/lr/793399/#clinicaltrials-connection). By default, the user action is only available for _Disclosures_ in the _Approved_ lifecycle state.  When you select **Generate and Submit**, Vault attempts to submit the _Disclosure_ submission file to ClinicalTrials.gov. Once Vault attempts to submit the _Disclosure_ submission file, Vault displays a response status message and attaches a response XML file to the _Disclosure_ record. The _PRS Upload Results_ section in the _Disclosure Overview_ layout shows all submission statuses and related attachments.  If the _Disclosure_ submission is successful, Vault displays the "New Study created on PRS" status message.
Vault will not submit the _Disclosure_ XML file if the _Disclosure_ record contains validation errors or the lifecycle locks the record from editing. Vault displays a status message to describe the reason for the failed submission attempt. To learn more about the specific error, click **View Attachments** on the status message. You can select **Generate and Submit** on the _Disclosure_ record once you resolve the errors and resubmit the _Disclosure_ submission file.  Admins can [configure](/en/lr/793399/) the _Disclosure_ record [lifecycle](/en/lr/30683/) to edit the states where users can submit submission files. ## Adding & Submitting Related Documents {#adding-submitting-related-documents} You can add Vault documents to a _Disclosure_ record by clicking **Add** in the _Related Documents_ section of the _Disclosure Overview_. We recommend filtering documents by _Study_ when selecting them. Once an Admin [configures and maps the document types](/en/lr/793399/#mapping-related-documents), you can submit the documents in the _Related Documents_ section to [ClinicalTrial.gov via the submission connection](/en/lr/793399/#clinicaltrials-connection) by selecting the **Post/Update Documents** action. You can only submit documents in the _Steady_ state. The _Post/Update Documents_ action opens a dialog that indicates which related documents will be posted. ## Viewing Protocol Registration & Results System (PRS) Details Once you submit your first _US Disclosure_ record to ClinicalTrials.gov via the [submission connection](/en/lr/793399/#clinicaltrials-connection), Vault updates the fields nightly in the _PRS Details_ section of the [_Registration_ record](/en/lr/899718/#creating-registrations) with the available information from ClinicalTrials.gov PRS. The _Check CTG PRS for Study Updates_ job runs nightly to update the _PRS Details_ section for all US _Registration_ records, allowing you to view the latest status of your _Study_'s disclosure process through its corresponding ClinicalTrials.gov _Registration_ record rather than requiring you to visit ClinicalTrials.gov PRS.  An Admin can [configure](/en/lr/793399/) Vault to notify you once the _Comments Posted_ field has the _Yes_ value. Admin can also configure a task for you to review the posted comments on ClinicalTrials.gov PRS. The _Review Comments Date_ displays the deadline for your review. [1]: #related-documents-section [2]: #creating-disclosures [3]: #automatically-creating-disclosures [4]: #updating-disclosure-form-fields [5]: #creating-disclosure-file [6]: #submitting-disclosure-file [7]: #adding-submitting-related-documents