PMDA Device Reports

1. Two new Japanese expedited device report forms have been added to all expedited report listing sections in Oracle Argus Safety.

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

     Report Form 8: Medical Device Malfunction/Infection Case Report (Form 8)

     Report Form 10: Medical Device Research Report/Measure in foreign countries Report

   • 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)

   • These forms are not added to the Utility Blank Report Form User Interface as the Utility Blank Report Form feature has been deprecated from Oracle Argus Safety 7.0.1 release onwards.

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. However, these WORD forms are not meant to be edited and updated back into Oracle Argus Safety application.

   • 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.
   • During Bulk Transmit Email process, these WORD report forms will not be merged even if Reporting Destination - Report Transmission Options have been configured to do so.

     Note:

     Merge feature is not required for these reports because the frequency of these Japan Device reports is quite low and there will hardly be any point of time when multiple WORD forms would exists in the system pending to be transmitted to a reporting destination.

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

   Note:

   These Japan Device Report Form 8 and 10 are not required to be supported on DLP case revision data as of now, because other PMDA Paper Reports and E2B are also not supported on DLP case revision data.

4. No mandatory field validation will be done during generation of these report forms, except for the following. All other validations are expected to be achieved by using Case Form Field Validations feature on the desired fields of the PMDA Device Information section.

   • 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 E2B:

   For E2B, if the "Destination" is selected as Agency with PMDA E2B(R2) or (R3) profile, then the product is populated in the Product drop-down based on the first available PMDA tab > License record, where the Reporting Category is set. If the Reporting Category is not set in the Analysis > PMDA tab for any of the license records, then the product is populated based on the left most suspect product that has the drug license. And on report generation, a message is displayed as Case does not have any matching reporting category found for the selected report forms. (選択された報告帳票と一致する報告分類が症例に存在しません。)

   Draft report generation for PMDA Paper reports:

   For PMDA Paper reports, if the "Destination" is selected as Agency with PMDA E2B(R2) or (R3) profile, the application check the selected Report Form, and the product is populated in the Product drop-down based on the first occurring of the PMDA tab > License record, where the corresponding Reporting Category is set applicable for the selected Report Form.

   If the Reporting Category is not set in the Analysis > PMDA tab for any of the license records, then the PMDA Report Form (PMDA報告様式) option is displayed in the Report Form drop-down for the PMDA paper report. When you select this option, the product is populated based on the left most suspect product having a drug license. On report generation, a message is displayed as Report cannot be generated because no reporting category is specified for the case. Please specify a reporting category on PMDA General tab. (報告分類が特定されていないため、報告を作成できません。PMDA情報の一般タブで報告分類を指定してください。)

   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. Malfunction without health damage

     b. Malfunction with health damage

     c. Infection

     Allowed Device Reporting Categories for PMDA Device Form 10:

     a. Research Report

     b. Measures in Foreign Country Report

     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. Manual Report Scheduling dialog for Argus J users is modified as specified below:

   If the user selects "Downgrade Report" as a drop-down option in the dialog header, then the "Report Form" drop-down list is updated to only display E2B and PMDA Marketed and Investigational Forms 1 - 6. Other expedited report forms or PMDA Device Report Forms are not displayed for "Downgrade Report" option.