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

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

## Configuring Product Family

The following is the list of changes in Product Family Configuration:

Product Family Configuration: "Comments (J)" text area field has been added right below the English "Comments" text area:

This field is displayed to only an Argus J user when Japanese module is enabled.

It is printed in the Product Family Configuration print PDF right after the English Comments field.

It is audit-logged and is covered by the back-end PL/SQL APIs for Product Family Configuration data table updates and audit-logging.

## Configuring Licenses

The following is the list of changes in License Configuration:

### PMDA Device Reporting Support in Console

The following is the list of changes for PMDA Device Reporting Support in Console:

1. Three new dropdown fields have been added to Console > Business Configuration > Products and Licenses.

   1. These dropdowns list fixed dropdown options, as specified below in the same order.

      PMDA Device Classification 1:

      High Level Controlled Medical Device

      Controlled Medical Device

      Generic Medical Device

      PMDA Device Classification 2:

      Biogenous

      Specific Biogenous

      Other

      PMDA Device Classification 3:

      Single Use Medical Device

      Reiteration Use Medical Device

      Figure 2-1 Console License Configuration - PMDA Device Classifications

   2. These fields have <Blank> as the default value for these drop-down lists.

   3. These fields are displayed to only an Argus J user when Japanese module is enabled.

   4. These fields are editable only when Authorization Country is selected as Japan and License Type is selection as either of "Marketed Device " or "Investigational Device". Otherwise, these are displayed as blank and disabled.

   5. The dropdown option values are displayed in English even to the Argus J user as this is an English base screen. The Japanese value specified for these dropdowns is used to populate these in PMDA Device Expedited Form 8 and 10.

   6. Existing fields - "Medical Device Information" and "Clinical Compound Number" have been adjusted in the user interface of the application.

   7. These three fields are printed in License Print PDF in three different rows, right below Clinical Compound Number field in alternate-colored rows thereafter.

   8. These fields are audit-logged.

   9. These fields are covered by the back-end PL/SQL APIs for License Configuration data table updates and audit-logging.

      Figure 2-2 Console License Configuration - Print PDF

2. A separate Japanese Comments field is supported for the following in Console ' Business Configuration.

   - License Configuration: "Comments (J)" text area field has been added right below the English "Comments" textarea:

     This field is displayed only to Argus J users when Japanese module is enabled.

     It is printed in the License Configuration print PDF right after the English Comments field.

     It is audit-logged and is also covered by the back-end PL/SQL APIs for License Configuration data table updates and audit-logging.

### Literature Intake Updates

The following is the list of Literature Intake Updates:

- A new checkbox - "Exclude from Report Candidates" field has been added to Console ' Business Configuration ' License Configuration screen as shown below.

  - This checkbox is displayed to only an Argus J user and when Japanese module is enabled.

  - By default, this field is unchecked.

  - This checkbox will only be enabled when the Authorization Country = Japan. Otherwise, it is unchecked and displayed as disabled.

  - This field value is printed in License Configuration print PDF.

  - The updates to this field value is audit-logged.

- When the product is populated in the case created through J Literature Intake module, it populates only one record in the Case Form Products tab for each Product in the matching Product Family. If there are multiple Japanese licenses for a product, then the correct license is picked up based on the following logic:

  - License Authorization Country = Japan

  - Withdrawn date is blank or >= current system date

  - "Hide" checkbox is not marked as checked for that product license combination

  - "Not in Tradename lookup/Not Autoscheduled" checkbox is not marked as checked

  - "Exclude from Report Candidates" checkbox is not marked as checked

  - If multiple licenses exist matching this criteria, then Earliest award date license are considered

  - If multiple licenses still exist matching this criteria, then the license with the lowest internal sequence number are considered.

- The following describes the change in logic that is used to populate Japanese licenses on Event Assessment and PMDA tabs. There is no change in logic for other country licenses. Manually Added Products through Bookin or Case Form or Case Intake or Affiliate Event Acceptance:

  - If the user selects a Japanese license during product selection in Bookin / Case Form / Affiliate Event, then only that license is considered for Event Assessment and PMDA tabs irrespective of the value of "Exclude from Report Candidates" checkbox.

  - If the user selects a non-Japanese license during product selection in Bookin / Case Form / Affiliate Event, then only the Japanese licenses for which "Exclude from Report Candidates" checkbox is not marked as checked is considered for populating Japanese licenses in Event Assessment and PMDA tabs.

- Products Added through Literature Intake:

  - Only the Japanese licenses for which "Exclude from Report Candidates" checkbox is not marked as checked are considered for populating Japanese licenses in Event Assessment and PMDA tabs.

- Products Added through E2B Import:

  - Only the Japanese licenses for which "Exclude from Report Candidates" checkbox is not marked as checked are considered for populating Japanese licenses in Event Assessment and PMDA tabs.

  - While identifying the product license to be used to populate the Products tab, only those Japanese licenses are used for which "Exclude from Report Candidates" checkbox is not marked as checked.

  - This is applicable to all the E2B factory profile logic - ICH, FDA, EMEA and PMDA.

- PMDA Event Assessment section on PMDA General tab:

  - Only the Japanese licenses for which "Exclude from Report Candidates" checkbox is not marked as checked are considered for populating Japanese licenses in Event Assessment and PMDA tabs.

- Manual Report Scheduling dialog > License # dropdown displays only those Japanese licenses which are available on Event Assessment tab.

- The following change has been made to the system while populating product licenses data in Case Form > Analysis tab > PMDA > General as well as Comment sub-tabs.

  - Marketed or Investigational Japanese Device Licenses is not populated, as PMDA General and Comments tab is not relevant for Device Reporting to PMDA.

  - Existing customer case data where Marketed or Investigational Japanese Device Licenses are already populated in PMDA General and Comments tab, have also been removed.

  - Removal of Marketed or Investigational Japanese Device Licenses from PMDA tab for existing customer data is audit logged with the "System" user.

## Configuring Studies

The application now allows the user to select a particular license that will be used to fetch the CCN and other related data.

The following changes have been made in Argus Console > Business Configuration > Study Configuration:

The Product Grid in both the English and J Study Configuration pop-up screens has been updated as follows:

Product, Dosage, Unit, and Formulation have been merged into one column called Product Name (Dosage Form / Strength / Unit), as shown below:

As listed above, a new license selection drop-down list has also been added in the J pop-up Product Selection grid. This drop-down lists all the J Licenses that are present for the respective product.

This license is used as the primary selected license when you select the product as the study drug in the Case Form, in the following format:

Trade name<space>(License Type)<space>Clinical compound Number or License Number

The License Type is printed as "MKT" for Marketed Drug/Device/Vaccine and "INV" for Investigational Drug/Device/Vaccine.

This license should be used as Primary license if the case is accepted as Initial/Follow-up from E2B, Literature Intake or Case Intake.

## Configuring Expedited Reporting Rules

The following is the list of changes in Expedited Reporting Rules Configuration:

A new dropdown field - "Device Reporting Category" has been added to Console > Business Configuration > Expedited Reporting Rules screen as displayed in the screen mockup below:

Figure 2-3 Console Expedited Reporting Rules Configuration - Device Reporting Category

- This dropdown field is displayed to English as well as Japanese users only when Japanese module is enabled.

- This dropdown displays the English values as specified in the "Device Reporting Category" Code List and marked as "Display".

- It contains <Blank> as the first option and it is also the default value.

- This field is printed in Expedited Report Rules Print PDF right below License Category field in alternating colored row.

- This field is audit-logged.

- It is covered by the back-end PL/SQL APIs for Expedited Reporting Rules data table updates and audit-logging.

  Figure 2-4 Console Expedited Reporting Rules Configuration - Print PDF