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Oracle® Argus Safety Japanese Administrator's Guide Release 8.0 E54655-01 |
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# 3 System Configuration

This chapter lists lists the Japanese-specific (J-specific) features in the System Configuration module of Argus Console.

## Configuring Commmon Profile Switches

This section describes the functionality for the J specific Common Profile switches.

A new tree-node has been added under Console > System Configuration > System Management (Common Profile Switches) >Argus J > Reporting as "Device Report Responsible Officer" with the following new switches in the exact same order as specified below:

- Company Name: Textbox, Maxlength = 100

- Department: Textbox, Maxlength = 100

- Address: Textbox, Maxlength = 60

- Telephone: Textbox, Maxlength = 50

- Fax: Textbox, Maxlength = 50

- Email: Textbox, Maxlength = 255

The existing common profile switch - "Offset from GMT used to calculate Japanese date/time fields for Interchange-J (in hours)" under Console > System Configuration > System Management (Common Profile Switches) > Argus J > Reporting has been renamed to "Offset from GMT used to calculate Japanese date/time fields (in hours)" to remove the reference of "Interchange-J" and use it for device reports as well as in addition to E2B.

### Common Profile Switches

This section explains the Common Profile Switches for Argus J.

The following figure is displayed when you navigate to Common Profile > Argus J:

The following table explains the fields used in the screen:

Field Name | Description | Field Options
--- | --- | ---
Enable half-width Alphanumeric characters forced input for Alphanumeric only fields | In the Argus J application, if this Profile Switch is on, the system automatically forces the input method to fixed half-width English when you enter data in the Alphanumeric only fields.For example, J user sets Japanese as input method on the client system, and without changing the input method, they can work through Argus J.Case Form:The following items are always alphanumeric input only regardless of the profile switch:All the fields in English UI are forced to enter half-width alphanumeric characters.Login fields are forced to enter half-width alphanumeric characters.All non-Japanese fields in the multi-language pop- up.The following items are forced to input Alphanumeric characters by profile switch:All global fields PMDA tabGeneral > Japan first information received date General > Japan follow-up received date |
Default viewing format of the PMDA E2B report (used with Electronic Submission Module (Interchange-J)) | This field represents the default viewing format of the PMDA E2B report (used with Electronic Submission Module (ESM))When PMDA Paper Form is selected, the system determines the correct paper format from the Reporting Category E2B item and creates paper draft image.Default Value: 1 | I SGML J SGML I Decoded View J Decoded View PMDA Paper Form
Shared Path for the Literature Intake | This field represents the shared path for the Literature IntakeDefault Value is blank | Maximum Length: 255
| PSR configuration UISubject of Report/Report NumberInvestigation Timeframe/Assigned DateInvestigation Timeframe/International BirthdateInvestigation Timeframe/Japanese Aware DateInvestigation Timeframe/Report is due ___days after specified end dateInvestigation Timeframe/Start DateInvestigation Timeframe/End DateReport Batch Printing popup / Run atReport Batch Printing popup / Due Date Console J:The following items are forced to input Alphanumeric characters by profile switch:All the J pop-up fields marked as S (Share same value as English one. So there is same database field for both) in Console J SRS Population Rule section.All the regular fields that have A (Alphanumeric only) in Input Lang Type classification of Console J SRS.Default Value is checked. |
Default Report type to be selected when Literature Intake item is booked-in | This field represents the default report type value for Book-in screen for cases booked-in through Literature Cases.Default Value is blank | Report Type configured in Console J
Default name of the Regulatory Agency for New Draft Expedited PMDA Reports from Analysis Tab of the Case Form | This field represents the defulat name of the regulatory agency for new draft expedited PMDA reports. | Reporting Destinations configured in the Console J

The following figure is displayed when you navigate to Common Profile > Argus J > E2B:

The following table explains the fields used in the screen:

Field Name | Description | Field Options
--- | --- | ---
E2B filename extension for Interchange -J | This field represents the E2B filename extension for ESM-JDefault Value: SGM | SGM
Perform Japanese character validation at E2B Check and E2B Report Generation. | If this is checked, the Japanese language check is performed during E2B Report Generation.Default value is checked. | This option is in the same section as Additional invalid characters to be checked in Japanese character validation.
Additional invalid characters to be checked in Japanese character validation | This field allows you to add invalid Japanese characters to be checked in Japanese Language check in the profile switch. | This option is in the same section as Perform Japanese character validation at E2B Check and E2B Report Generation When the Perform Japanese character validation at E2B Check and E2B Report Generation checkbox is unchecked, this field is disabled.
Characters to be allowed to use in AN (Alphanumeric) E2B items | In this field, you can enter English characters allowed in Argus J. When this is entered, the English characters E2B check validates if AN fields (Allow Japanese Characters=No) has undefined characters in the Profile Switch.The E2B check displays following error message when invalid character(s) (characters not configured in the Profile switch) are found in the E2B item:Value of element [element tag] has invalid English character(s).Default Value: ABCDEFGHIJKLMNOPQRSTUVWXYZabcdefghijklmnopqrstuvwxyz0123456789.E+- !"#$%'()*+,-.:;=?@[\]^_/{|}~ |
Drug assessment source for reported causality (used by E2B/Interchange-J module) | This function for the B.4.k.18.2 is different from EMEA rule, as in EMEA these values are hardcoded in the application while in PMDA they come from the CMN_Profile switch. | Field Length: 120JAudit Log: Yes
Drug assessment source for determined causality (used by E2B/Interchange-J module) | This function for the B.4.k.18.2 is different from EMEA rule, as in EMEA these values are hardcoded in the application while in PMDA they come from the CMN_Profile switch. | Field Length: 120JAudit Log: Yes
Drug assessment method (used by E2B/Interchange-J module) | The field value chosen in the Case Form > Event Assessment tab is populated for B.4.k.18.3 DRUGASSESSMENTMETHOD field for the Product Event combination selection for E2B report mapping. If you have the Drug Assessment Method field hidden for the Case Form, the value for B.4.k.18.3 DRUGASSESSMENTMETHOD is set to the value in this field by default. | Field Length: 70JAudit Log: Yes
Seriousness criteria in Event Reportability Matrix | The Event Reportability algorithm used by the PMDA E2B and Paper Reports considers seriousness criteria value as Case Level or Event Level seriousness based on the value set for this common profile switch.Default Value: Event Level Seriousness | Case Level Seriousness Event Level Seriousness

The following figure is displayed when you navigate to Common Profile > Argus J > Reporting:

The following table explains the fields used in the screen:

Field Name | Description | Field Options
--- | --- | ---
Auto Distribution Transmission Comments (J) | This field allows you to enter the Japanese Transmission comments used for Expedited Reports Transmission, which are auto-distributed by the system based on Expedited Reporting Rules or Reporting Destinations.These comments are used in the same way as Auto Distribution Comments, but when J user is on the system. | Field Length: 1000Audit Log: Yes
Auto Distribution Submission Comments (J) | This field allows you to enter the Japanese Submission comments used for Expedited Reports Transmission, which are auto-distributed by the system based on Expedited Reporting Rules or Reporting Destinations.These comments are used in the same way as Auto Submission Comments, but when J user is on the system. | Field Length: 1000Audit Log: Yes
Offset from GMT used to calculate Japanese date/time fields for Interchange-J (in hours) | This field represents the offset from GMT that is used to calculate Japanese date/time fields. ESM-JDefault Value: 7 |
Text to display as comment when a downgrade report is scheduled | The field length is 2000 J.The text appears in the Report Detail > Comment tab. |
"Follow-Up Action Item for Incompletion Report Submission""Due In ____ days" |  | Populated based on Action Type Code list values (not deleted and not hidden)
Major Developed Countries for Approval Status in J-DSUR | This field lists the countries to be considered as major developed countries for J-DSURs. | Text box with 1000 characters limit, without any default value. Users can also configure comma-separated A2 country codes.
Follow-up Action Item for Incompletion Report Submission Group Assignment | This field represents the user group to which the Incompletion Report Submission Action Item is assigned.Default value is blank. | User Groups from Console
Count each event as reported in that timeframe | Enables you to count each event as reported in the specified timeframe. |
Count each event from a case with the timeframe where the case was reported first | Enables you to count each event from a case with the timeframe where the case was reported first. |
Configured Datasheets | Enables you to configure datasheets as per your requirements. |
Case Event Assessment | Enables you to assess the case event. |
Event counting logic for PSR Form 3, 4 and ReSD Form 4, 5 | Default option is radio button option #1. If this option is selected, then PSR form 3,4 and ReSD Form 4,5 shall count all events from the timeframe reported.If radio option # 2 is selected, then the PSR Form 3, 4 and ReSD Form 4, 5 shall be updated to count / print all the events from case only under the timeframe where that case was reported first. Even if a new event (new event_seq_num) from a case has been reported in an E2B / Paper Report to PMDA in the current reporting period, still it shall be counted / printed under the original timeframe. | Count each event as reported in that timeframe Count each event from a case with the timeframe where the case was reported first.
Event counting logic for PSR Form 3, 4 and ReSD Form 4, 5 | If this common profile switch is set to "Yes", then when the case is locked from any point in Argus Safety application, it shall trigger the fresh calculation of the PMDA Event Reportability data. | Yes, No (Default).
Listedness Assessment Source for PSR and ReSD | When switch is set to "Configured Datasheet", the listedness shall be determined based on the configured Datasheets.When the switch is set to "Case Event Assessment", the listedness is considered from the Case Event Assessment data in the following sections of the report: a. PSR Form 3 (and ReSD Form 4) b. PSR Form 4 (and ReSD Form 5) c. ReSD Tabulations i. Tabulation for UnListed Events ii. Tabulation for Listed Events. | Configured Datasheets, Case Event Assessment (Default).

PIP PMDA Profile Integration for No Reportable Events

The existing Argus Safety application applies a check for existence of reportable events for PMDA E2B generation for transmission and import process. Due to this check, cases with un-encoded events or missing causality cannot be accepted successfully during follow up import process as reportable events scenario is not met for such follow ups. The Inform-Argus PIP profile has removed the check of reportable events from their profile SQLs. However, because of the 'No reportable' events check during E2B generation for follow up import, it is not possible to accept any follow-up report.

This scenario is encountered during Inform when other system sends un-encoded events to Argus.

This problem has been fixed only for custom PMDA profile. Argus Safety is now providing an option of excluding 'No Reportable' events check during PMDA E2B generation for transmission and import process based on a common profile switch 'PIP PMDA PROFILE'':

1. Argus Safety now excludes the 'No Reportable' events check for a PMDA E2B report for custom PMDA profile configured in the 'PIP PMDA PROFILE' switch. This will allow a follow up report for a configured custom profile to be imported even though there are no reportable events in the case.

2. No Reportable events check is excluded for E2B generation both for transmission and import scenarios.

#### Profile Switch for Incompletion Report Submission - Auto Action item

- When this action item is configured, the system creates an action item automatically when Incompletion report is submitted. (Mhlwadmicsrcompleteclass, 1=Incomplete, 2=Complete, Case Form/Analysis/PMDA/PMDA General/Incompletion checkbox)

- Blank (Default): if this option is present in the Action Item drop-down, the system does not create any Action Items for the Incompletion Report Submission (current functionality).

- Action Item drop-down (Codelist):

  - This option displays all the Action Items configured within the Code List Action type which are not deleted or allowed to be viewed.

  - If there is a value selected, the system creates an Action Item which would be Due in, as defined by you.

  - The Due in field allows you to enter up to 99 days.

  - The group assigned to the Action Item is Unassigned.

  - The Action Item is created as soon as the status of the Incompletion Report is changed to Submitted.

- The Audit Log tracks the updates made to this field.

- Once the Follow-up Completion Report is submitted, the Action Item associated to the report is Closed with the Close Date as the System Date (Server date).

- If the Follow-up report is still an incompletion report, the Action Item remains open.

- If the report is nullified (Nullification Report is sent), the Action Item is closed.

- When there are multiple incompletion reports from one case, the system creates the action items, which are same in number as that of the reports generated.

- The system prepends a default text in front of description (J): Incompletion Report: XXX where XXX refers to the text entered in the Description (J) field.

- The Group can be assigned using the Follow-up Action Item for Incompletion Report Submission Group Assignment profile switch.

## Configuring Field Level Validations

This section lists the configuration of fields in Argus Console.

### Field Label Configuration (J Specific)

In order to change the field labels, to hide and unhide fields in Case Form, navigate to System Configuration > Field Validation. This displays the following screen:

Note: The Field Form Label (J) and Help Text (J) are visible on this screen (grid, data entry, and print) only to Argus J user, when Argus J module/license is enabled.

The following table explains the J specific labels on the screen mentioned above:

Field Name | Description
--- | ---
Field Form Label (J) | This field allows you to edit the field labels. It is valid only for the labels where label change is allowed. This is an optional field.
Help Text (J) | You can enter the help text here for a selected field. This is an optional field.

#### PMDA Downgrade/nullification Report Scenario when All Events are Non-Reportable

When reportable event is deleted from a Case Form by significant follow-up change, downgrade report against E2B to PMDA cannot be sent. Also, user is not able to send the nullification report when all the reportable events are deleted.

As per MHLW notification for investigational drugs, if reportable events disappears (becomes invalid events) by follow-up information and if there are no "reportable event" as result, it is necessary to report as nullification report. If reportable event(s) become non-reportable by follow-up information then a downgrade report is sent.

For Marketed drugs, when events in the case are updated in such a manner that none of the events in the case is valid then only nullification report is sent. If the reportable event becomes non-reportable by the follow-up information then a downgrade report shall be sent.

1. Definition of "Non-Reportable" and "Invalid" events:

   - Non-Reportable events - same as it exists today.

   - Invalid events are:

     - Deleted events and

     - Those events for which the "Not include for the report in Japan" (available in the Case Form | Japan Event tab) checkbox is checked

2. The PMDA E2B follow-up Downgrade report is generated when all the valid events in the case became "non-reportable". A downgrade report shall:

   - Include all the latest valid events that exist in the case.

   - Ignore non-coded events as it has already been implemented in the current functionality.

   - Not reference previously submitted report's data.

3. For Marketed reports (reporting categories (1, 2, 3 and 4), In a scenario when events in the case are updated in such a manner that none of the events in the case remains valid (as described in the point # 1b above) then the PMDA E2B Nullification report is generated.

4. For investigational reports (reporting categories (8, 9, 10, and 11), if all the reportable events w.r.t. previously submitted report becomes invalid (as described in the point # 1b above) by the follow-up information then the PMDA E2B Nullification report is generated.

5. As per the existing implementation, the nullification E2B report will get its data (including the REACTION section) from the previous submitted E2B XML.

6. When the nullification E2b reports is auto-scheduled for the above mentioned scenarios:

   - A new common profile switch "PMDA E2B Nullification Reason Text for No Valid Event Scenario" is created in console under Argus J > Reporting with default value in Japanese - (There is no valid event available in the case). The profile switch is a text box having a maxlength of 200 characters. It support English as well as Japanese data entry.

   - The value specified in the common profile switch "PMDA E2B Nullification Reason Text for No Valid Event Scenario" is used for the value of E2B element A.1.13.1 NULLIFICATIONREASON in PMDA E2B.

This enhancement is applicable for PMDA E2B Downgrade/nullification reports.

## Configuring Field Labels

This section displays the updates made to the user-defined fields.

### User Defined Fields Updates

The Argus J system has the following:

- Argus J allows you to enter Japanese drop-down items as well as English.

- Only the English drop-down is a mandatory field. When the English drop-down value is not present, an error message, User Defined Dropdown English values can not be blank is displayed.

## Configuring Local Reports - Local Reporting Rule and Local Reports

In order to control which reports need to be generated only after Local data entry is done, the application maintains a list of Report forms that are considered as Local Reports, by storing the following data fields:

- Country - This is typically the country of license of the suspect product in a case for which there is a local reporting obligation. This could also be the local country expecting an active moiety reporting.

- Reporting Destination - This is the reporting destination receiving the local report. This shall be populated based on user input during post upgrade script.

- Report Forms - This is the local report. This is stored with the following reports for this release, as displayed in the image below:

A reporting rule that is for the Country + Reporting Destination + Report Form is the Local Reporting Rule.

Any reporting rule that is for the country + reporting destination + report form configured in the above table and in addition satisfies the Truly Local Case system criteria for the case from which these rules are triggered (i.e., the SQL or PL/SQL block or the database function configured in the 2.3.0 returns a value > 0) is referred to as Local reporting rules.

Any report that is scheduled by a Local reporting rule is considered a Local report (note that this would have already satisfied the Truly Local case switch as described above).

For the purpose of this release, this configuration data is maintained via backend procedures and no maintenance facility needs to be provided via UI.

Note that to utilize the local locking feature, the customer is expected to maintain the proper Reporting Destination value in this table.

Expedited Reports generated as part of Periodic Reports are not considered local reports for this release.