Japan DSUR report updates

Summary

Japan DSUR report updates

Description

JDSUR report configuration and mappings are enhanced as per the revised PMDA R3 guidance for Clinical Studies. An option is added to select additional study products in report configuration. These are printed in Form 1 and Form 2, with Form 2 repeated for each study product.

Report configuration updates

The report configuration lists the available additional study products - auto-populated with Study ID, and Product Name of all products configured in the Console > Study Configuration from all study arms including the WHO drugs and J drugs except the study products already selected in the Selected Products (選択された製品) list box. You can select any additional study products to be included in the JDSUR report.

Form 1 updates

In Form 1, a new column for 被験薬以外の治験使用薬情報 (Drugs used in clinical trials other than the investigational drug) is added just below the 主要先進国における承認状況 (Approval Status in major developed countries). This prints the products selected in the JDSUR Configuration > Product Selection tab > Selected Additional Study Products field. Details like Generic Name, Product Type, Clinical Compound Number of the Study, and Notification Number of the Study are printed.

Form 2 updates

Form 2 is repeated for each product selected under Selected Products (選択された製品) list box and Selected Additional Study Products (選択された治験薬) list box. A new column for 治験使用薬の記号・名称等 (Code/Name of the Clinical Trial-Use Medicine) is added to the form. For study products configured in Selected Products, the new column prints Clinical Compound Number, and Study ID. For study products configured in Additional Study Products, the new column prints Generic Name, Product Type, and Study ID.

Product Type code list

A new standard code list is introduced for Product Type. The values added here are displayed for user selection in the Console > Studies > Product Type dropdown in English and J data entry screens.

For more information on the JDSUR updates, refer to the JDSUR report mapping guide.