Japanese Clinical Trial Notifications (CTMS)

For Vault 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 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 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.

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

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.