PMDA Device Paper Reports

1. The existing Form 8 and Form 10 paper reports have been enhanced to support revised format paper report.

   • The following form options are displayed (in Japanese) to both English as well as Japanese users:

     Report Form 8: Domestic or Foreign infection case report / Domestic or Foreign defect case report (Form 8)

     Report Form 10: Medical device research /survey report / Survey report of foreign safety measures (Form 10)

   • These form options are displayed to both Japanese as well as English users.
   • These form options are supported at all the following locations in Oracle Argus Safety:
     • Console J - Expedited Report Rules - Form Section (irrespective of whether Japanese module is enabled or disabled)
     • Console J - Code list / Batch report generation (irrespective of whether Japanese module is enabled or disabled)
     • Case Form - Toolbar - Draft (only if Japanese module is enabled)
     • Schedule New Expedited Report dialogue - "Form" drop-down (only if Japanese module is enabled)
     • Medical Review - Preview of Expedited Report (only if Japanese module is enabled)
     • Create Unscheduled report (only if Japanese module is enabled)
     • View Submitted report (irrespective of whether Japanese module is enabled or disabled)
     • Bulk Report by Form (irrespective of whether Japanese module is enabled or disabled)

2. These report forms open up in Microsoft Word format (.doc) from all the places in Oracle Argus Safety application as specified (but not restricted to) in the above specified list using the following forms provided by PMDA retaining all its fields, drop-downs and macros.

   • The message box which prompts to ask the user if the expedited report will print blinded data or not is not displayed for these Japan Device Report Forms as there is no blinded data printed in these reports.

3. These report forms are generated in Microsoft Word format (.doc) itself from both Draft and Final mode.

4. The application performs validation checks based on the conformance rules of the PMDA Device Report and lists all the failing validations in the PMDA Device Validation Report. If the case data has the necessary data to meet the conformance rules, the application generates the report in Microsoft Word format (.doc).

   • If the value specified in Case form/Products tab/Device sub tab/PMDA Device Information section/Medical Device Reporting Category drop-down for the product for which the report is scheduled does not match with the allowed values for Form 8 or Form 10, then instead of opening the Report Form, application displays an error in the standard Oracle Argus Safety message box with OK button and the following message:

     'Case does not have matching device reporting category for the selected device report form'

   • The same error is logged as a report generation error, including if it occurs during background generation through Argus Safety Service. This error is also visible in the Report Details dialog - General tab at the bottom, as is displayed for the E2B generation errors.

5. Regulatory Reporting Rules Algorithm:

   • The Argus Safety Expedited Reporting Rules engine also considers "Device Reporting Category" drop-down value while matching rules against cases. It gets compared against the Case Form ' Products tab ' Device sub tab ' PMDA Device Information section ' Medical Device Reporting Category drop-down field value.
   • Argus Safety Expedited Reporting Rules engine scheduled the due date for these Japanese Device reports based on the Japan Aware Date, as configured in Reporting Destination configuration.
   • The Argus Safety Expedited Reporting Rules engine schedules only one Japanese Device Report for each matching rule, for each suspect device product in a case, even if the case has multiple Japanese Device Licenses of the same License Type in the Event Assessment tab of the case. It also respects the Reporting Destination configuration for "Suppress Duplicate Reports", as configured.
   • If multiple matching product licenses of the same device license type exist for a suspect device product in the Event Assessment tab, the license with the earliest award date of the matching product is considered for scheduling the report.
   • If the original product license for which the initial / previous follow-up report was scheduled is no longer available but another product license of the same product matching the same rule exists, then a follow-up report is scheduled in subsequent cycles instead of a downgrade.

     Downgrade is scheduled only when no licenses for that product matching that rule exist in the case.

6. Draft report view is generated based on user selection for Report Form, Destination, and Product. For more details, refer to the Oracle Argus Safety Administrator's Guide.

   The Draft report view is available from the following areas:

   • Toolbar—Draft icon
   • Medical Review screen
   • Coding Review screen
   • Local Affiliate > Local Labeling > View Default Report
   • Local Affiliate > Local Labeling > Medical Review > View Draft

   Draft report generation for PMDA Device Report Forms 8 and 10:

   • It uses the first matching suspect device product as per the sort order of products in the case form products tab which has the matching "Medical Device Reporting Category" specified in the "PMDA Device Information" section.

     The following criteria is used to find matching Medical Device Reporting Category for the Japanese Device Form:

     Allowed Device Reporting Categories for PMDA Device Form 8:

     a. Domestic infection case report

     b. Domestic defect case report

     c. Foreign infection case report

     d. Foreign defect case report

     Allowed Device Reporting Categories for PMDA Device Form 10:

     a. Medical device research/survey report

     b. Survey report of foreign safety measures

     Earliest award date: Japanese marketed device active license (withdrawn date later than the Initial Receipt date) of such product is used.

     If Japanese marketed device license is not available, the Japanese investigational device license matching the above specified criteria is used.

     If no such Japanese device license is available for the matching product, then it considers matching any (irrespective of license country or license type) earliest award date active device license for the product.

     In case of multiple device licenses with same award date, it uses the license with the earliest internal license id (primary key) value.

   • If no product exists with the matching "Medical Device Reporting Category" for the Report Form, then instead of opening this form, the application displays an error in the standard Argus Safety message box with OK button and message - Case does not have matching device reporting category for the selected device report form.
7. For Form 10 nullification report, PMDA expects paper report instead of XML report and hence a new Form 10 nullification paper report is supported.

   When the nullification reason is entered for Form 10, Oracle Argus generates the Form 10 XML Nullification report. Take care to use the Form 10 Paper form to submit the PMDA as PMDA does not accept Form 10 XML Nullification report and expects only Paper form for Form 10 nullification. To manage the submission in Oracle Argus, manually update the acknowledgment details and mark the report as submitted.

8. The PMDA paper reports are generated in JIS A4 size.