2 System Configuration

2.1.1 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:

2.1.2 Common Profile Switches for Reporting

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

The following table explains the fields used in the screen:

PIP PMDA Profile Integration for No Reportable Events

The existing Argus Safety application checks for 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 now has 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.

2.1.3 Common Profile Switches for Device Report

The following screen is displayed when you navigate to Common Profile > Argus J > Reporting > Device Report:

Device Report Responsible Officer

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

• Responsible Officer – Company Name: Textbox, Maxlength = 100

• Responsible Officer – Department: Textbox, Maxlength = 100

• Responsible Officer – Address: Textbox, Maxlength = 60

• Responsible Officer – Telephone: Textbox, Maxlength = 50

• Responsible Officer – Fax: Textbox, Maxlength = 50

• Responsible Officer – 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 and E2B.

The following common profile switches are available under Common Profile > Argus J > Reporting > Device Report:

• SQL used to populate the Listedness field on the PMDA Device report form 8 (parameters: P_CASE_ID, P_PRODUCT_ID, P_LICENSE_ID, P_AGENCY_ID, P_PROD_SEQ_NUM)

• SQL used to identify Events to be printed under Status of Patient's health damage field on the PMDA Device report form 8 and 10 (Parameters: P_CASE_ID, P_PRODUCT_ID, P_LICENSE_ID, P_AGENCY_ID, P_PROD_SEQ_NUM)

2.1.4 Common Profile Switches for E2B

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

The following table explains the fields used in the screen:

2.1.5 Profile Switch for Incomplete 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 appends 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.

2.2.1 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:

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

2.3.1 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.