This article describes the Japanese configurations that Admins must perform for Vault CTMS to submit Clinical Trial Notifications (CTN) to the Japanese Health Authority (PDMA). Initial Japanese configuration is completed by Veeva Services and can be modified as needed to fit the needs of your organization.
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
Contact Veeva Support to enable the Japanese CTN feature in your CTMS Vault. You can also contact Veeva Support to enable the Create CTN Data for Japanese Study Country feature, which allows 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. If you do not ask Veeva Support to enable this feature, you can manually create CTN Data records via Vault Loader.
Note that once this option is enabled, it cannot be disabled.
After Veeva Support enables these features in your Vault, 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.
Note: 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 Yuzu Japanese CTN before disabling the feature.
CTN Lifecycle States
The CTN Lifecycle has five (5) 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
Configure the user action to generate CTN items in the Draft state of the CTN Lifecycle:
- Navigate to Admin > Configuration > Object Lifecycles > CTN Lifecycle.
- Open the Draft lifecycle state.
- Edit the User Actions section, then click Create Rule.
- Select the Always radio button.
- Select Generate CTN from the picklist.
- Select the appropriate Document Type and Document Lifecycle.
- Enter an Action Label and click Save.
Configuring the Generate Global Change Log Immediately Action
Vault schedules the Change Log job instance 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:
- Navigate to Admin > Configuration > Object Lifecycles > CTN Data Lifecycle.
- Open the applicable lifecycle state.
- Edit the User Actions section, then click Create Rule.
- Select the Always radio button.
- Select Generate Global Change Log Immediately from the picklist.
- 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 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.