# Using Japanese Clinical Trial Notifications (CTN)

For CTMS customers that run clinical trials in Japan, Vault provides the ability to generate and submit Clinical Trial Notifications (CTN) to the Japanese Health Authority (PDMA). Vault provides the ability to fulfill J-GCP requirements by generating and managing Japanese CTN with other clinical trial activities through a set of functions.

Note that your Admin must have [configured Japanese Clinical Trial Notifications](/en/lr/62049/) for these options to appear in your Vault.

## Related Objects

  * **Clinical Trial Notification / 治験届**: Stores CTN information. The data in this object is in Japanese.
  * **CTN Data / 治験届関連情報**: Stores CTN related information for existing objects, such as _Organization_, _Person_, _Product_, _Site_, _Study Organization_, and _Study Person_.
  * **CTN Site IP/ 治験施設治験薬情報**: Stores Investigational Product distribution information for each site.
  * **CTN IP Name / 治験薬名称**: Stores the Investigational Product name, study, and study country.
  * **CTN Data Change Log**: Keeps track of changes made to the information stored in the CTN.
  * **CTN Attached Document / 届出書添付資料**: Stores attachment information for a specific CTN.
  * **CTN Remarks / 備考**: Stores remarks for a specific CTN.
  * **Clinical Regulatory Vocabulary:** Stores values used in the CTN such as _Administration Code_, _Dosage Form Code_, and _Medical School Code for Investigators_.
  * **CTN Combination Equipment / 併用する機械器具等**: Stores information about Combination Equipment included in the CTN.
  * **CTN Combination Product / 治験使用薬等**: Stores information about Combination Products included in the CTN.
  * **CTN Reference CTN / 参照する治験届出情報**: Stores information about other CTNs related to the current CTN.

## Organization & Person Management

You can manage Japanese person and organization information by selecting either the **CTN Organization for Japan** or **CTN Person for Japan** checkboxes on an _Organization_ or _Person_ record.

This allows you to store CTN related information for Japanese sites and investigators.

## Creating the Clinical Trial Notification

The CTN contains clinical trial information and associated documents that clinical trials must submit to the PDMA. You can generate the notification using the data captured in the _Clinical Trial Notification_ object and in other objects related to study. To do this:

  1. Create Japan as a study country under the study related to the clinical trial and add relevant organization and person information such as Candidate Sites, PI, and CRO.
  2. Execute the **Country Selected** option on the country from the **Actions** menu to change the state to _Initiating_.
  3. Once in the _Initiating_ state, a CTN section will appear on the _Country_ record. Click **Create** to create a new CTN, and choose a type, for example, _Protocol Notification_.
  4. Enter all required CTN information. Vault automatically populates the _Study Site_ field on _Study Organization_ and _Study Person_ types of CTNs based on the related _Study Site Person_ or _Study Site Organization_.
  5. Optional: If [configured](/en/lr/62049/) you can set the **Use Study Specific Info / 試験固有の情報を使用** field to **Yes** on _Study Organization_, _Study Person_, and _Study Site_ types of _CTN Data / 治験届関連情報_ records. This prevents the study-level details on the CTN from changing if those organization- and person-related details change after the CTN is generated.
  6. Optional: Execute the **Select Site** option on sites to enter CTN information.
  7. Select the option to generate CTN items from the **Actions** menu of the CTN object to generate the notification for review. Vault prepares the notification in the schema required by the PDMA and exports it as a Microsoft Word document.

If Vault identifies any validation errors, it displays the _CTN Generation Errors_ window. From here, you can review the errors and determine how to proceed. If you select **Cancel and Correct**, Vault does not generate the CTN and sends you back to the CTN record to correct the errors. If you select **Generate Anyway**, Vault bypasses the identified errors and creates the CTN. Selecting **Generate Anyway** results in a CTN that may contain errors and require manual correction before submission. In addition, Vault captures the **Generate Anyway** action in the Audit Train along with the user who performed the action.

When the _Generate CTN_ action is sucessful, Vault generates three files:

  * Notification content Microsoft Word document.
  * Administration information Microsoft Word document attachment.
  * XML attachment attachment.

Vault stores the administration information and XML files as attachments to the notification content file in your **Library**. The document type is set according to [how your Admin configured the action to generate CTN items](/en/lr/62049/#generate-ctn-items).

Vault does not generate CTN items unless:

  * At least one Study Site record exists that contains:
      * A _Study Person_ with the _Principal Investigator_ role.
      * At least one _CTN Site IP_ record.
  * The _Study Country_ record contains a person assigned _Applicant Representative / 治験届出担当者_ as a _Study Team Role_. If there are multiple _Applicant Representative / 治験届出担当者_ roles, they cannot have matching orders.
  * The _Study Organization_ record contains one of the following _Study Organization Roles_:
      * _Trial Applicant / 治験届出者._
      * _Manufacturer or Importer / 製造所又は営業所._
  * The _Include in CTN / 届出書記載_ field is set to _Yes_ for the _Study Site_, _Study Person_, and _Study Organization_ records.

When you complete the review workflow, Vault moves the CTN to the _Ready for Submission_ state. In this state, the generated XML and Microsoft Word files are locked and cannot be edited.

### Amendment Notifications

You can create _Amendment CTNs_ from existing CTNs that you've already submitted and finalized. Execute the **Create Amendment CTN** action from the **Actions** menu of the target CTN. This action copies the appropriate fields from the target CTN to the new _Amendment CTN_ record allowing you to make any changes needed.

After you make all necessary changes, you can select the option to generate CTN items from the **Actions** menu to generate a new XML and Microsoft Word documents for review.

### Change Log

Vault tracks changes in the _CTN Item Change Log_ section. You must enter a **Changed Date** and **Changed Reason** on the _CTN Item Change Log_ records that Vault creates. The _CTN Item Change Log_ tracks all changes made to CTNs, remarks, study sites, site IPs, study persons, and study organizations as required by PMDA to be included in the CTN.

Change Logs do not track:

* Updated information for sites that were added in this CTN.
* _CTN Actual Subject # / 被験者数_ for _Trial Termination_ and _Trial Completion_ CTNs.
* The addition or deletion of a _Applicant Representative / 治験届出担当者 Study Person_

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: To update the <em>Applicant Representative</em>, the recommended action is to update the <em>Person</em> reference for the <em>Study Person</em> record.  This allows an updated <em>Change Log</em> record to be created.</p>
    </div>
  </div>
</div>



Vault schedules the creation of change logs when you update a _CTN Data / 治験届関連情報_ record. Your Admin can configure the **Generate Change Log Immediately** action to trigger the job to run rather than wait for the change log job to run at its scheduled time.

To generate the change log:

  1. Navigate to the _CTN Data / 治験届関連情報_ record related to a _Study Person_ or _Study Organization_ record.
  2. Set the **Include in CTN / 届出書記載** checkbox.
  3. Click on the **Actions** menu.
  4. Select the **Generate Change Log Immediately** action.

### Additional Notifications

You can also create the following notifications. These notifications share similar fields with amendment notifications and follow the same workflow.

  * _Study Closure CTN_: Submitted when a study is complete.
  * _Study Termination CTN_: Submitted when a study is prematurely terminated.
  * _Development Termination CTN_: Submitted when a decision is made to prematurely terminate the development of an investigational product in a protocol notification.

### Create Subsequent CTN Records

When the Health Authority provides the stamped CTN, upload the document to the CTN record and move the CTN record to _Accepted_ state. From the accepted record, you can create one subsequent CTN record for each existing CTN by selecting **Create Subsequent CTN** from the **Actions** menu.

Vault copies most of the field values entered for the initial CTN upon the creation of the subsequent CTN. Additional fields are displayed based on which CTN type you selected.

You can create subsequent CTN records for Initial or Amendment CTN types that are in the _Submitted_ state of the _CTN Lifecycle_.

## CTN Site IP Management

You can define the CTN Site IP and track IP counts for each site. You must first create _CTN IP Name / 治験薬名称_ records to add them to _Study Site_ records.

To create the _CTN IP Name / 治験薬名称_ records:

  1. Navigate to the _IP Name / 治験薬名称_ section of the _Study Country_ record for Japan.
  2. Click **Create**.
  3. Enter a **Name**.
  4. Click **Save**.

To add a _CTN Site IP/ 治験施設治験薬情報_ to a _Study Site_ record:

  1. Navigate to the _CTN Site IP/ 治験施設治験薬情報_ section of the _Study Site_ record.
  2. Click **Create**.
  3. Enter the details of the CTN site IP. Note that your Vault must contain _IP Name / 治験薬名称_ records to be selectable in the **IP Name / 治験薬名称** field.
  4. Click **Save**.

## CTN Generation Limitations

In compliance with PDMA requirements, CTNs cannot contain characters outside of JIS Level 1 and Level 2 character sets.