Clinical Safety Update Japan (CSUJ) reports all the cases in study to the Pharmaceuticals and Medical Devices Agency (PMDA). Generate CSUJ report and CSUJ Line Listing reports to submit to the Japanese regulatory agency (PMDA) for the study cases.
The reports generates the adverse reaction or infectious disease of a study case (Foreign or domestic) during the clinical study to the following groups.
Reporting to the Investigators
Reporting to the Authority
This chapter explains about generating the report using Clinical Drug Code and Combined Drug Code issued from the authority for a drug in study.
Before you begin generating the CSUJ (line listing) report, you must first set the Report parameters by logging into the ARISj Admin url.
By setting the report parameters, the application displays the optional fields and determines the layout of the report.
ARISj user copies the data entered in the Admin in Suspect Product tab in Full Data Entry, and CPD lookup for product with Clinical Drug Code and Combined Drug Code.
Important: Application allows you to fetch the cases based on the parameter ”Search with” available in the report selection criteria for generating the Line listing reports.
Reporter Country field in the report supports Data Privacy.
To generate the CSUJ report:
On the Reports Menu, click CSUJ. The CSUJ Selection Criteria window opens.
At a minimum, enter the following information in the CSUJ Selection Criteria window.
Latest version of the case with latest received date between the current survey period (start and end date) in the selection criteria.
Note: If a highest version of the case does not satisfy the minimum criteria then consider the next highest version.
Note: Case should be approved. For template 2 do not consider logically deleted or nullified cases. However, CSUJ LL report prints the unapproved cases.
Select a primary suspect drug or all suspect drugs.
Select a reaction record coded with MedDRA Dictionary.
Set the Causality relationship in reporter and company fields.
Note: To set the relationship as Yes, either you set the assess causality relationship as "Yes” or do not set the parameter.
Note: To set the relationship as No, set the assess causality relationship in both the fields as not related.
When you create the case from the data entry screens:
Make sure the case contains one of the following information:
Patient ID (Patient Initial): You must enter this field and the application does not print the values "XX, X.X., X.X” on the report.
Sex: Select either "MALE” or ”FEMALE”.
Age:You must enter a value.
Age unit:You must enter a value.
Age group: You must enter a value.
Make sure the case contains one of the following information:
Source
Reporter information
Investigator information
Literature information
Note: For Template 2 considers combination of Source and Study Type
Do not consider nullified authority records.
Select the report you want to generate by clicking the check box (CSUJ or CSUJLL).
Click Generate. The application displays the message: Generating the CSUJ Report… and opens the report in Microsoft Word editor.
Note: You must enter the Reporting Decision Date and Report times, in-order to generate the CSUJ report.
To save the selection criteria page, click Save.
For more information on saving and loading the selection criteria page, refer to the Saving Selection Criteria MHLW Reports.
Template – 2 prints the count reaction with SOC and PT/LT. View the count in the Domestic Study (Current and Accumulation), Foreign Study (Current and Accumulation) and Foreign Spontaneous – Others (Current and Accumulation) columns.
Check the option Consider Project No./Protocol No. for classification checkbox in the CSUJ Report Parameter from Admin. (Refer ARISj Specific guide)
The classification of cases are as follows:
When Domestic Study Cases match with the entered Project number and Protocol number in the selection criteria the count appears in Domestic Study column else the case is ignored.
When Foreign Study cases match with the entered Project number and Protocol number in the selection criteria the count appears in the Foreign Study column else it prints in the Foreign Spontaneous column.
Additionally in Template – 2, blank cells displays Zero (0).
Selection criteria window consists of following tabs.
Selection
Layout
Blinding Support