About the Feature
With the 23R3 release, Vault Safety provides clinical trial-related PMDA E2B(R3) generation enhancements to address the revised pharmaceutical affairs law requirements for clinical trial submissions and TIKEN scenarios.
- When reporting Study Cases for Clinical Trial Studies registered in Japan, the system populates the J2.12 Clinical Compound Number (CCN) data element based on the Study Registration’s CCN when available. When the CCN is blank on the Study Registration, the system continues to map the CCN of the Primary Case Product Registration from the Local Reporting Details.
- In both scenarios, the J2.13.r section repeats for each Study with a Japan Study Registration that has a Clinical Compound Number field with the same CCN transmitted in J2.12.
- When a foreign Case has multiple Japan-reportable investigational Product registrations with the same substance, the system provides a way to configure multiple CCNs for a single Case primary Product.
- In a scenario where a foreign Case includes both postmarketing and investigational registrations and meets the Under Partial Change Trial criteria so that the PMDA requires only a postmarketing Transmission, selecting the new TIKEN field in the Product Reporting Details section prepends "TIKEN" on the G.k.11 Additional Information on Drug (free text) data element. In addition, Admins can now set up product registrations with the new “Under Partial Change Trial (TIKEN)” registration type.
- In generated PMDA E2B(R3) reports, on the J2.4.k License Category of New Drug and J2.14.i Expectedness data elements, the J-OID Code System version is updated to 1.2.
After configuring this feature, see Set Up the Localized Business Admin Library: Japan Localized Study Fields and E2B Generation Data Mapping: PMDA E2B(R3) for more details.
Prerequisite
This feature is Auto-on, however, some components require additional configuration. Before you can use this feature, you must complete the configuration for the PMDA Multi-Submission with Localized Case feature.
Add the Clinical Compound Number Field to Japan Study Registrations
Complete the following steps to include the Clinical Compound Number field when adding a Study Registration with the Country field set to Japan:
- Go to Admin > Configuration > Objects > Study Registration > Page Layouts > Study Registration Detail Page Layout.
- In the Details section, add the Clinical Compound Number field.
- Select Save.
- Select Study Registration Detail Page Layout to return to the page layout.
- Select Layout Rules.
- Select Create and then configure the fields of the Layout Rule as follows:
- Label: Enter a label, for example, “CCN for Japan”.
- Description: Enter a description, for example, “Show the Clinical Compound Number field for Study Registrations in Japan.”
- Hide the following Page Layout Items:
- Type: Fields
- Values: Clinical Compound Number
- IF this Layout Rule Expression is TRUE:
country__vr.name__v != "Japan"
- Select Save.
Add the Product (Reported) Override Field to Product Registrations
Complete the following steps to include the Product (Reported) Override field on Product Registration records:
- Go to Admin > Configuration > Objects > Product Registration > Page Layouts > Product Registration Detail Page Layout.
- In the PMDA section, add the Product (Reported) Override field.
- Select Save.
Add the Product (Reported) Override Field to Case Product Registrations
Complete the following steps to include the Product (Reported) Override field on Case Product Registration records for Japan:
- Go to Admin > Configuration > Objects > Case Product Registration > Page Layouts > Japan Detail Page Layout.
- In the Details section, add the Product (Reported) Override field.
- Select Save.
Add the TIKEN Checkbox to Local Reporting Details
Complete the following steps to include the TIKEN checkbox on Case Local Reporting Details records:
- Go to Admin > Configuration > Objects > Local Reporting Details > Page Layouts > Local Reporting Details Detail Page Layout.
- In the Details section, add the TIKEN field.
- Select Save.
