# Configuring Japanese Clinical Trial Notifications (CTN)

This article describes the Japanese configurations that Admins must perform to submit [Clinical Trial Notifications (CTN)](/en/lr/62051/) to the Japanese Health Authority (PDMA).

The PDMA requires that CTNs cannot contain characters outside of JIS Level 1 and Level 2 character sets. Vault prevents you from configuring CTN-related objects and records with invalid characters to ensure compliance with this requirement.

## Enabling Japanese Clinical Trial Notifications
To enable Japanese Clinical Trial Notifications, navigate to **Admin > Settings > Application Settings** and, under _CTMS Features_, select the **Enable Japanese CTN Feature** checkbox.

To allow Vault to automatically create CTN Data / 治験届関連情報 records for all existing _Study Organizations_, _Study Persons_, and _Study Sites_ that have _Japan_ in the _Study Country_ field, also select the **Create CTN Data for Japanese Study Country** checkbox.

You can manually create _CTN Data_ records via [Vault Loader](/en/lr/26607/).

Once these options are enabled, they cannot be disabled.

You can navigate to **Business Admin > Picklists** and edit the _CTN Version_ picklist to remove English language strings. This ensures that Vault generates the XML and DTN documents according to PDMA standards.

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      <p><strong>Note</strong>: After enabling this feature, later disabling it may result in some elements becoming hidden or inactivated. To avoid this, we recommend removing any unnecessary records and configuration related to Japanese CTN before disabling the feature.</p>
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## CTN Lifecycle States

The _CTN Lifecycle_ has five predefined states:

  * **Draft**: The initial state of a CTN or the state a CTN returns to if changes are needed after submission. The XML file can be generated and reviewed in this state.
  * **In Review**: CTN fields are typically locked and can no longer be edited.
  * **Ready for Submission**: The _Review Workflow_ is complete and the files are typically locked.
  * **Submitted**: The Health Authority returned the CTN Receipt. If changes are needed, the CTN can be put back to Draft state after being submitted.
  * **Accepted**: PMDA accepted the first or subsequent CTN.

Configure the CTN lifecycle states to update according to the requirements of your organization.

## Configuring the Generate CTN Action {#generate-ctn-items}

Configure the user action to generate CTN items in the _Draft_ state of the _CTN Lifecycle_:

  1. Navigate to **Admin > Configuration > Object Lifecycles > CTN Lifecycle**.
  2. Open the **Draft** lifecycle state.
  3. **Edit** the _User Actions_ section, then click **Create Rule**.
  4. Select the **Always** radio button.
  5. Select **Generate CTN** from the picklist.
  6. Select the appropriate **Document Type** and **Document Lifecycle**.
  7. Enter an **Action Label** and click **Save**.

## Configuring the Generate Global Change Log Immediately Action

Vault schedules the _Change Log_ [job instance](/en/lr/24762/) to run when changes are made to a _CTN Data / 治験届関連情報_ record if the _Include in CTN / 届出書記載_ field is set to _Yes_ on the related _Study Person_ and _Study Organization_ records.

You can give users the ability to trigger the job to run immediately with the _Generate Global Change Log Immediately_ user action. This action is available as a standard action on the _CTN Data / 治験届関連情報_ object. To add it as a user action to specific lifecycle states:

  1. Navigate to **Admin > Configuration > Object Lifecycles > CTN Data Lifecycle**.
  2. Open the applicable lifecycle state.
  3. **Edit** the _User Actions_ section, then click **Create Rule**.
  4. Select the **Always** radio button.
  5. Select **Generate Global Change Log Immediately** from the picklist.
  6. Enter an **Action Label** and click **Save**.

## Configuring the CTN Review Workflow

When a CTN enters the _In Review_ state, the generated CTN items should go through a review workflow. [Document review workflows](/en/lr/50498/#update-field) for managing CTN submission may be configured to support the requirements of your organization.

## Updating Object Page Layouts

Object page layouts must be configured in a specific way to support CTN generation. Contact Veeva Services for information about modifying CTN-related layout sections.