Oracle Argus Interchange

Japan User's Guide

Release 8.1.2

F11651-01

October 2018

Oracle Argus Interchange Japan User's Guide, Release 8.1.2

F11651-01

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Contents

Preface

- Where to Find More Information

- Documentation Accessibility

- Revision History

1 About Argus Interchange

- 1.1 Argus Interchange Process Overview

2 Configure Argus Interchange

- 2.1 Argus Interchange Mapping Utility

- 2.1.1 Configure the Argus Interchange Service

- 2.1.1.1 Service INI File Setup Dialog Box

- 2.1.2 Add a Database for Argus Interchange Service

- 2.1.2.1 Service DB Setup Fields

- 2.2 E2B Extensions (Applicable for R2 only)

- 2.3 Web Console

- 2.3.1 Configure Regulatory Authorities

- 2.3.1.1 EDI Tab Fields

- 2.3.2 Configure SMTP

- 2.3.2.1 SMTP Configuration Dialog Box Fields

- 2.3.3 Configure Code List Items

- 2.3.3.1 Configure an Action Taken

- 2.3.3.2 Configure Age Groups

- 2.3.3.3 Configure Age Units

- 2.3.3.4 Configure Attachment Classifications

- 2.3.3.5 Configure Dosage Units

- 2.3.3.6 Configure an Event Outcome

- 2.3.3.7 Configure Gender

- 2.3.3.8 Configure Report Type

- 2.3.3.9 Configure Reporter Type

- 2.3.3.10 Configure Routes of Administration

- 2.3.3.11 Configure a Message Type

- 2.3.3.12 ICSR Length Check

- 2.3.3.13 E2B Code Validation

3 ICSR Check

- 3.1 Why perform an ICSR Check

- 3.1.1 ICSR Validation

4 Transmit and Monitor ICSR Reports

- 4.1 Log In and Out of Argus Safety

- 4.1.1 To Log Out of the Argus Application

- 4.2 Schedule an E2B Report

- 4.2.1 New Expedited Report Dialog Fields

- 4.3 View a Scheduled E2B Report

- 4.4 Transmit E2B Reports

- 4.4.1 Transmit Bulk Reports by Form

- 4.4.2 Monitor ICSR Transmit Statuses

- 4.4.2.1 ICSR Transmit Status Fields

- 4.4.2.2 Message Acknowledgement Status Dialog Fields

- 4.4.2.3 PMDA ACK Import Logic

- 4.4.3 Monitor ICSR Receive Statuses

- 4.4.3.1 ICSR Receive Status Dialog Fields

- 4.4.3.2 Message Acknowledgement Status Dialog Fields

- 4.4.3.3 Validation Check of Incoming Message

- 4.4.4 Nullification Reports

- 4.4.5 View Statuses

- 4.4.6 View Acknowledgement Information

5 Use the ICSR Viewer

- 5.1 Open the ICSR Viewer

- 5.1.1 PMDA E2B Report Mapping

- 5.2 Export an SGML File

6 Import ICSR Reports

- 6.1 Incoming ICSR Reports

- 6.1.1 Search for Duplicate Cases

- 6.1.1.1 Duplicate Search Dialog Box Fields

- 6.1.2 Use the View Differences Report

- 6.1.2.1 Displaying Differences

- 6.1.3 View the E2B Report

- 6.1.4 Accept Single/Multiple E2B Reports

- 6.1.5 E2B Initial/Follow-up Intake

- 6.1.6 E2B Follow-up Acceptance for Closed/Locked Cases

- 6.1.7 Source XML Received for the Case

- 6.1.8 Import E2B (R3) Messages

- 6.1.9 ICSR Pending Screen for (R3) Report

- 6.1.10 PMDA E2B R3 ACK

- 6.2 Processed ICSR Reports

- 6.2.1 Total Number of Rows Fields

Glossary

Preface

This guide provides documentation on the tasks related to the handling of E2B reports in Argus Safety. These include configuration, validation, viewing, transmitting, monitoring, and import of E2B reports.

Where to Find More Information

Oracle Help Center

The latest user documentation for Oracle Health Sciences products is available at http://docs.oracle.com/en/industries/health-sciences/.

My Oracle Support

The latest release notes, patches and white papers are on My Oracle Support (MOS) at https://support.oracle.com. For help with using MOS, see https://docs.oracle.com/cd/E74665_01/MOSHP/toc.htm.

Documentation Accessibility

For information about Oracle's commitment to accessibility, visit the Oracle Accessibility Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.

Access to Oracle Support

Oracle customers that have purchased support have access to electronic support through My Oracle Support. For information, visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=info or visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired.

Revision History

Version, Date

Description

1.0, February 2018

Refer to the Oracle Argus Interchange Japan User's Guide 8.1.1.

2.0, October 2018

Updated the guide to fix the following documentation related bug.

- 27128039 - Dummy Reaction for Research and Measurement report (R3) field

1 About Argus Interchange

Argus Interchange provides pharmaceutical manufacturers with a simple, efficient way to comply with electronic standards for transferring regulatory information through the use of an Electronic Data Interchange (EDI) gateway. It also enables you to view E2B reports in different formats, such as I-SGML, J-SGML, I-Decoded View, J-Decoded View, and PMDA Report Form. These reports can be submitted to trading partners or to regulatory authorities.

1.1 Argus Interchange Process Overview

The following flowchart shows the steps to follow when using Argus Interchange.

The following table describes each of the steps in the preceding flowchart.

Task

Description

Logging on

Explains how to log on to Argus Safety.

Schedule E2B Report

Explains how to schedule an E2B Report for a case using the New Expedited Report dialog.

View E2B Report

Explains how to view a scheduled E2B Report in the E2B viewer and check for validation errors.

Transmit E2B Report

Explains how to transmit E2B reports by using the Bulk Reporting features in Argus Safety.

View Statuses

Explains how to view and understand the status of a transmitted E2B report.

View Acknowledgement

Explains how to view the detailed acknowledgement information from a trading partner or a regulatory authority.

The following flowchart displays the steps to import E2B Reports through Argus Interchange:

The following table describes each of the steps in the preceding flowchart.

Task

Description

Incoming E2B Reports

Explains how to view Incoming E2B Reports.

View E2B Reports

Explains how to view an Incoming E2B Report in the E2B viewer.

Duplicate Search

Explains how to search for possible duplicate cases in the Argus Safety system.

View Difference Report

Explains how to view differences between the current XML being imported (a message not yet imported into the database), the current case data in the database and the last imported case.

Accept/Reject

Explains how to accept or reject single/multiple E2B Follow-up/Initial reports.

View Process E2B Reports

Explains how to view the processed E2B Reports.

2 Configure Argus Interchange

This section is intended for Argus Interchange Administrators. The flowchart shows the steps to follow when configuring, reviewing, and administering Argus Interchange.

2.1 Argus Interchange Mapping Utility

Argus Interchange mapping utility enables you to configure the Argus Interchange Service. This chapter provides the following information:

- Configure the Argus Interchange Service

- Add a Database for Argus Interchange Service

Note:
Most features of the Interchange have been moved to the web-based console.

2.1.1 Configure the Argus Interchange Service

You can configure the Argus Interchange Service by updating the initialization (INI) file from the Argus Interchange Mapping interface.

1. In the Windows 2012/2012R2 server, navigate to Apps and click the ESM Mapping tool. This opens the Service INI Set up dialog box.

2. Use the items in the Service INI File Setup dialog to configure the Argus Interchange Service INI file.

3. Enter the data for each field as required.

2.1.1.1 Service INI File Setup Dialog Box

The following tables lists and describes the fields in the Service INI File Setup dialog box.

Item

Description

IT E-mail

Enter the e-mail address that Argus Interchange Service should use to send e-mails, if the transmit time out occurs for Physical Media or EDI Gateway.

Business E-mail

Enter the e-mail address that Argus Interchange Service should use to send e-mails, if the Receive ACK time-out value is reached.

User E-mail

Enter the e-mail address that Argus Interchange Service should use to send e-mails, when the user does not process the E2B Report within the time-out value. The Argus Interchange Service uses SMTP as its mail system.

Sender E-mail

Enter the e-mail address that Argus Interchange Service should display, as the 'From' address in the e-mails that it sends.

EDI Gateway

Select the name for the EDI Gateway - from either Axway Cyclone or Oracle B2B.

EDI Database Name

Enter the database name for the EDI software.

EDI User ID

Enter the user name for EDI database.

EDI Password

Enter the password for the user name associated with the EDI database.

DTD Path

Enter the path for the DTD file.

Log File Path

Enter the path where the Argus Interchange Service will write the log files.

Multiple Database Section

Displays all the configured databases for ESM Service.

Delete Button

Click Delete to remove the entire Database Configuration from ESM Service INI File.

2.1.2 Add a Database for Argus Interchange Service

You can configure the Argus Interchange Service to support multiple database.

To configure a database:

1. In the Setup INI File dialog box, double click Add New Process to open the Service DB Setup dialog.

2. Use the items in the Service DB Setup dialog to configure the ESM Service INI file.

3. Enter the data in the fields as required.

Note:
ESM Service.ini can be configured for MAX_FILES_IMPORT_PER_RUN at database level under the Database section. This should be set to a number. This determines how many files are read from incoming folder so as to allocate to Receive Process(es). This includes both ICSR reports and Acknowledgments. If it is not defined, an internal limit of 1000 is assumed.

2.1.2.1 Service DB Setup Fields

The following table lists and describes the fields in the Service DB Setup dialog box.

Item

Description

Database Name

Enter the name of the Adverse Event database.

Unique Database ID

Identifies each database uniquely. In the case of multiple databases, the value of this field should be unique.

User ID

Enter the user name for the Service.

Password

Enter the password associated with the User Name entered in the USER ID field.

Process

Enter the full path of the ESMProc.exe file. The system uses this path to locate the ESMProc.exe file.

Receive Process

Enter the full path of the E2BReceive.exe file. The system uses this to locate the E2BReceive.exe file.

Archive Folder

Enter the full path where the system places the file processed by Argus Interchange.

Receive Processes Count

Enables you to specify multiple E2B receive processes
You can specify from 1 to 5 E2B receive processes

The default is 1.

Process Elapse Time

Enter the time interval for the Argus Interchange Process to run.

Enter EDI Transmit Time out Value

The amount of time, in minutes, that must pass before the system sends an e-mail message when an E2B Report has not been transmitted within a specified time period.
Note: The minimum value for the time-out is 10 minutes.

Enter Physical Media Transmit Time out Value

Enter amount of time, in minutes, that must pass before the system can send an e-mail message when an E2B Report has not been sent manually by a specified person within a specified time period.
Note: The minimum value for the time-out is 10 minutes.

Enter Receive ACK Time Out Value

Enter the amount of time, in minutes, that must pass before the system can send an e-mail message when an ACK message has not been received within a specified time period.
Note: The minimum value for the time-out is 10 minutes.

Enter Processing Time Out Value

Enter the amount of time, in minutes, that must pass before the system can send an e-mail message when an Incoming Report has not been processed within a specified time period.
Note: The minimum value for the time-out is 10 minutes.

Enter XML Transmit Time Out Value

Enter the amount of time, in minutes, that must pass before the system can send an e-mail message when an XML file is not picked up by the Gateway.
Note: The minimum value for the time-out is 10 minutes.

Enter Binary Transmit Time Out Value

Enter the amount of time, in minutes, that must pass before the system can send an e-mail message when a binary file is not picked up by the Gateway.
Note: The minimum value for the time-out is 10 minutes.

Enter MDN Time Out Value

Enter the amount of time, in hours, that must pass before the system stops polling the MDN information from the EDI server after receiving the Business ACK for a transmitted report.

2.2 E2B Extensions (Applicable for R2 only)

You can use the existing reporting destination configuration to choose an extended E2B profile. The system uses the agency and company identifier to identify the profile to use and sends the information in the following XML elements:

<messagesenderidentifier>Company X</messagesenderidentifier>

<messagereceiveridentifier>Agency Y</messagereceiveridentifier>

The Interchange mapping utility also supports the defined extended E2B elements as follows:

- A switch in the Interchange mapping tool identifies a profile as either a standard profile or an extended E2B profile but only for the Receive tab. The additional fields are formatted as follows:
<XXX>_EXTENSION []

where:

XXX is the tag name followed by _EXTENSION to indicate that this is an extended E2B tag element

When using this switch:

- Do not enter any blank spaces or underscore characters ( _ ) in the XXX naming convention.

- In the extended E2B tags, the element number in the brackets ( [ ] ) is always empty. For example, Patient Ethnicity, Event Hospitalized Start Date / Stop Date.

- This switch is enabled only for profiles copied from the Factory profiles (default unchecked). This flag is disabled for all factory profiles.

- During configuration, GPS updates the DTD profile with this information before it adds any additional E2B elements.

- The system maps extended E2B fields are mapped to existing Argus fields or to user-defined fields, as appropriate. For example, the system maps the following extended E2B fields to the following Argus tables.

E2B + Field

Argus Case Form UI Field Name

Argus Field Label Description

patientethnicity_extension

PATIENT | Patient Ethnicity

Patient Ethnicity

reactionintensity_extension

EVENTS | Event Intensity

Event Intensity

reactionhospstartdateformat_extension

Argus Date entry format YYYYMMDD or YYYYMM or YYYY

Hospitalized Start Date Format

reactionhospstartdate_extension

EVENTS | Hospitalized Start Date

Hospitalized Start Date

reactionhospstopdateformat_extension

Argus Date entry format YYYYMMDD or YYYYMM or YYYY

Hospitalized Stop Date Format

reactionhospstopdate_extension

EVENTS | Hospitalized Stop Date

Hospitalized Stop Date

- The system sends an acknowledgement if the message import is successful and a rejection if the message import is not successful.

You can view the extended elements for the following:

- E2B Viewer

- No updates to the CIOMS / MedWatch Reports

- The Decoded View / SGML View displays the additional elements added as a part of the Extended E2B

- E2B Difference Report

- When imported, the system displays the additional fields in the current difference report viewer.

- E2B Selective Intake for Initial and Follow up E2B Reports

- You can selectively import the additional fields the system adds to the Extended E2B in the Argus case.

- The PDF reports display the additional fields added to the Extended E2B.

- The E2B Warnings/Errors display the warnings/errors if warnings or errors defined for the fields added to the Extended E2B.

2.3 Web Console

The Web Console enables you to configure the Regulatory Authorities to which E2B Reports need to be submitted. In accordance with ICH Guidelines, you can configure additional Code List items with new E2B codes.

2.3.1 Configure Regulatory Authorities

Transmitting E2B reports to an Agency/Trading Partner, requires you to create a regulatory authority entry in the Code List. After creating the regulatory authority, you can transmit regulatory reports to it.

To configure a regulatory authority:

1. On the Argus Console, Click Code Lists -> Argus.

2. When the system opens the Code List Maintenance screen, select Reporting Destination from the list.

Note:
If a report has already been generated for a Regulatory Authority, the system disables the Delete button in the Code List dialog box for the particular Regulatory Authority. However, it is still possible to modify these reports there.

Refer to the Argus Safety Guide for information on using the first three tabs of the Reporting Destination.

3. Click the EDI tab, select the appropriate data for each item, and enter the data in the fields as required.

2.3.1.1 EDI Tab Fields

The following table lists and describes the fields on the EDI tab.

For Argus J users, an additional field called "Message Profile 2" shows up for the configuration of the PMDA - J profile. This field is required for PMDA agency to specify PMDA J profile.

Field

Purpose

SGML/XML

Enables you to select whether to send the report in SGML or XML format.

Mark as Auto Submit

Enables you to mark the report for auto submission.

Imported Cases are assigned to

Enables you to select the country where imported cases need to be assigned.
Note: This list contains the configured Argus sites. The default value is the site of the importing user.

Initial Workflow State

Enables you to configure the initial workflow state for the case.
Note: This list contains Argus workflow states. The default value is blank. If you select blank as the workflow state, the system treats the case as a new case being booked-in.

Agency Identifier

Enables you to enter the routing ID configured in Cyclone for the sender community.

Identification Code

Enables you to enter the agency Duns code, a unique code that identifies a trading partner.

Code Qualifier

Enables you to enter the code qualifier. The system uses the code qualifier to interpret the identification code.

XML Source Classification

Defines the E2B source file classification during the E2B import. The system populates this drop-down from the Attachment Classification code list.

Selection Source Classification

Defines the classification of the PDF for initial intake or the difference report during E2B import. The system populates this drop-down from the Attachment Classification code list.

Message Profile

Enables you to select a message profile.

Message Profile 2

Enables you to select a message profile for J elements. This profile is enabled for J users.

ACK Profile

Enables you to select the acknowledgement profile.

Primary Receive Agency

Indicates that this is the primary agency receiving E2B reports.

Auto Accept ICSR's

Enables or disables the auto-accept E2Bs for the agency.

Transmit E2B Attachments

Enables or disables transmission of E2B attachments for the agency.

Use Japanese Aware Date for Reporting

Check this checkbox to use Japanese Aware Date for reporting.

Allow multiple reports for Marketed Drugs

Check this checkbox to allow multiple reports for Marketed Drugs.

Allow multiple reports for Investigational Drugs

Check this checkbox to allow multiple reports for Investigational Drugs.

Identification Code

Enables you to enter the company Duns code, a unique code that identifies a trading partner.

Company Identifier

Enables you to enter the company identifier.

Code Qualifier

Enables you to enter the code qualifier. The code qualifier is used to interpret the identification code.

File Name

Enables you to enter the file name

SGML Declaration File

Enables you to enter the SGML Declaration File.

Maximum # of reports to include in the msg

Enables you to enter the maximum number of reports that will be transmitted in one message.

Method

Enables you to select a method. This field contains E2B-EDI Gateway, E2B Physical Media, and E2B-XML Transmission values.

EDI Header Required

Enables you to generate the required EDI Header.

XML Version

Enables you to enter the XML Version.

URL of Message DTD

Enables you to enter the path where the message DTD resides on the Internet or to enter the full path, if it is located on the disk.

Encoding

Enables you to select the character set encoding used in XML

Use Japanese Aware Date for Reporting

Enables you to ensure that reporting is based on the Japanese Aware Date. If this checkbox is not checked, reporting is based on the English Aware Date.

Allow multiple reports for Marketed Drugs

Checking this checkbox allows the system to schedule multiple reports for marketed drugs.

Allow multiple reports for Investigational Drugs

Checking this checkbox allows the system to schedule multiple reports for investigational drugs.

URL of ACK DTD

Enables you to enter the path where the ACK DTD resides on the Internet or enter the full path, if it is located on the disk.

Note:
In the File Name field, be sure to enter the appropriate naming convention followed by "####" before the transmission extension.

2.3.2 Configure SMTP

Argus Interchange Mapping Utility can be configured to send emails to notify the appropriate people on the occurrence of some incidents or errors while processing E2B reports. These emails are sent using Argus Safety Service. You can use Argus Console if you need to configure these emails to be sent using SMTP.

To enable Argus Safety Service to use the SMTP protocol to send e-mail to the e-mail server, use the SMTP Configuration Utility in the following way.

To configure SMTP:

1. Open Argus Console.

2. When the system opens the Code List Maintenance screen, click System Configuration -> SMTP Configuration.

3. When the system opens the SMTP Configuration dialog box, enter the appropriate data in each field.

2.3.2.1 SMTP Configuration Dialog Box Fields

The following tables lists and describes the fields in the SMTP Configuration dialog box.

Item

Description

Server IP or Name

The SMTP server IP address or name.

Port

The port number. The default port number is 25.

Authentication

The authentication type to use.
Basic Authentication -- The user must enter a user name and password in the Username and Password fields.

No Authentication -- The Username and Password fields are disabled.

NTLM Authentication, the authentication of the OS user logged into the system is automatically passed. Additionally, the Username and Password fields are disabled in this authentication.

SMTP Username

The SMTP username.

SMTP Password

The SMTP password.

Enable SMTP?

Select this check box to ensure that AG Service uses SMTP to send e-mail.

2.3.3 Configure Code List Items

Argus Safety is currently shipped with E2B Codes for the applicable factory data items. If you enter new items, E2B codes must be derived from ICH guidelines and entered as described here.

Note:
From Argus Console, click Code Lists -> Argus to open the Code List Maintenance screen.

2.3.3.1 Configure an Action Taken

Use the following procedure to configure action taken:

1. From the Argus Console, select Code Lists -> Argus -> Action Taken.

2. When the system opens the Code List Maintenance screen, click Action Taken in the Code List in the left pane.

3. The system puts the corresponding data for the selected item in the right pane.

4. Click Add New and enter the E2B code for the new action in the Add New Action Taken section.

5. Click Save.

2.3.3.2 Configure Age Groups

Use the following procedure to configure age groups:

1. From the Argus Console, select Code Lists -> Argus -> Age Groups.

2. When the system opens the Code List Maintenance screen, locate and click Age Groups in the Code List in the left pane.

3. The system places the corresponding data for the selected item in the right pane.

4. Click Add New and enter the E2B Code for the new age group in the Add New Age Groups section.

5. Click Save.

2.3.3.3 Configure Age Units

Use the following procedure to configure age units.

1. From the Argus Console, select Code Lists -> Argus -> Age Units.

2. When the system opens the Code List Maintenance screen, click Age Units in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Click Add New and enter the E2B Code for the new age unit in the Add New Age Units section.

5. Click Save.

2.3.3.4 Configure Attachment Classifications

Use the following procedure to configure attachment classifications:

1. From the Argus Console, select Code Lists -> Argus -> Attachment Classification.

2. When the system opens the Code List Maintenance screen, click Attachment Classification in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Click Add New and click the E2B Additional Doc check box in the Add New Attachment Classification section.

5. Click Save.

2.3.3.5 Configure Dosage Units

Use the following procedure to configure dosage units:

1. From Argus Console, Code Lists -> Argus -> Dosage Units.

2. When the system opens the Code List Maintenance screen, click Dosage Units in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Select an existing Dosage Unit and enter the new E2B code in the Modify Dosage Units section.

5. Click Save.

2.3.3.6 Configure an Event Outcome

Use the following procedure to configure an Event Outcome:

1. From the Argus Console, select Code Lists -> Argus -> Event Outcome.

2. When the system opens the Code List Maintenance screen, click Event Outcome in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Enter the E2B Code for the new event outcome in the Add New Event Outcome section.

5. Click Save.

2.3.3.7 Configure Gender

Use the following procedure to configure Gender.

1. From Argus Console, select Code Lists -> Argus -> Gender.

2. When the system opens the Code List Maintenance screen, click Gender in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Enter the E2B Code for the gender in the Add New Gender section.

5. Click Save.

2.3.3.8 Configure Report Type

Use the following procedure to configure Report Type:

1. From the Argus Console, select Code Lists -> Argus -> Report Type.

2. When the system opens the Code List Maintenance screen, click Report Type in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Enter the E2B code for the new report type in the Add New Report Type section.

5. Click Save.

2.3.3.9 Configure Reporter Type

Use the following procedure to configure Reporter Type:

1. From the Argus Console, select Code Lists -> Argus -> Reporter Type.

2. When the system opens the Code List Maintenance screen, click Reporter Type in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Enter the E2B Code for the new reporter type in the Add New Reporter Type section.

5. Click Save.

2.3.3.10 Configure Routes of Administration

Use the following procedure to configure Routes of Administration:

1. From the Argus Console, select Code Lists -> Argus -> Routes of Administration.

2. When the system opens the Code List Maintenance screen, click Routes of Administration in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Enter the E2B Code for the new route of administration in the Add New Routes of Administration section.

5. Click Save.

2.3.3.11 Configure a Message Type

Use the following procedure to configure a Message Type:

1. From the Argus Console, select Code Lists -> Argus -> Message Type.

2. When the system opens the Code List Maintenance screen, click Message Type in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Enter the new message type and other relevant data in the Modify Message Type section.

5. Click Save.

2.3.3.12 ICSR Length Check

When you select ICSR Length Check, the system generates a report that prints the code list item length check and M2 validation warnings. This menu item has been added under Argus Console -> Tools -> ICSR Length Check.

The following table lists the Code List items the length check is run on.

Data Element

LM Field

Argus Field Length

DTD Allowed Length

A.2.1.1d

LM / Clinical Studies / Study Information / Study Description.
The application needs to consider the EUDRA-CT length (35) while displaying the message.

2000

100

A.3.1.3b

LM / Regulatory Authorities / Local Company Contact / Title

40

10

A.3.1.4a

LM / Regulatory Authorities / Local Company Contact / Address

120

100

A.3.1.4f

LM / Regulatory Authorities / Local Company Contact / Phone

20

10

A.3.1.4g

LM / Regulatory Authorities / Local Company Contact / Phone / Ext.

10

5

A.3.1.4i

LM / Regulatory Authorities / Local Company Contact / Fax

50

10

A.3.1.4j

LM / Regulatory Authorities / Local Company Contact / Fax / Ext.

10

5

A.3.2.2c

LM / Regulatory Authorities / Agency Information / Contact Information / Title

40

10

A.3.2.2f

LM / Regulatory Authorities / Agency Information / Contact Information / Last Name

40

35

A.3.2.3a

LM / Regulatory Authorities / Agency Information / Contact Information / Address

120

100

A.3.2.3f

LM / Regulatory Authorities / Agency Information / Contact Information / Phone

20

10

A.3.2.3g

LM / Regulatory Authorities / Agency Information / Contact Information / Phone / Ext.

10

5

A.3.2.3i

LM / Regulatory Authorities / Agency Information / Contact Information / Fax

50

10

A.3.2.3j

LM / Regulatory Authorities / Agency Information / Contact Information / Fax / Ext.

10

5

A.2.1.2c

LM / Reporter Information / Address

120

100

B.4.k.2.2

LM / Products / Key Ingredient

120

100

B.4.k.4.1

LM / Licenses / License Information / Number

40

35

2.3.3.13 E2B Code Validation

The following table lists the E2B Code Validation items.

Tag Name

DTD Element

Case Form Field

LM Field

primarysourcecountry

A.1.1

Case Form / General / Reporter Information / Country

LM / Countries / Code (A2)

occurcountry

A.1.2

Case Form / General / General Information / Country

LM / Countries / Code (A2)

reporttype

A.1.4

Case Form / General Information / Report Type

LM / Report Type / E2B Code

reportercountry

A.2.1.3

Case Form / General / Reporter Information / Country

LM / Countries / Code (A2)

qualification

A.2.1.4

Case Form / General / Reporter Information / Reporter Type

LM / Reporter Type / E2B Code

observestudytype

A.2.3.3

Case Form / General / Study Information / Observe Study Type

LM / Case Classification / E2B Code

sendertype

A.3.1.1

LM / Regulatory Authorities / Local Company Contact / Sender Type

LM / Regulatory Authorities / Local Company Contact / Sender Type

sendercountrycode

A.3.1.4e

LM / Regulatory Authorities / Local Company Contact / Country

LM / Countries / Code (A2)

receivertype

A.3.2.1

LM / Regulatory Authorities / Agency Information / Agency Type

LM / Regulatory Authorities / Agency Information / Agency Type

receivercountrycode

A.3.2.3e

LM / Regulatory Authorities / Agency Information / Contact Information / Country

LM / Countries / Code (A2)

patientonsetageunit

B.1.2.2b

Case Form / Patient / Patient Information / Age Units

LM / Age Units / E2B Code

patientagegroup

B.1.2.3

Case Form / Patient / Patient Information / Age Group

LM / Age Group / E2B Code

patientsex

B.1.5

Case Form / Patient / Patient Information / Gender

LM / Gender / E2B Code

parentageunit

B.1.10.2.2b

Case Form / Patient / Parent / Age Unit

LM / Age Units / E2B Code

parentsex

B.1.10.6

Case Form / Patient / Parent / Gender

LM / Gender / E2B Code

reactionoutcome

B.2.i.8

Case Form / Events / Event Information / Outcome of Event

LM / Event Outcome / E2B Code

testunit

B.3.1e

Case Form / Patient / Lab Data / Lab Data / Units

LM / Dossage Units / E2B Code

obtaindrugcountry

B.4.k.2.3

Case Form / Products / Product Information / Obtain Drug Country

LM / Countries / Code (A2)

drugauthorizationcountry

B.4.k.4.2

LM / Licenses / License Information / Country

LM / Countries / Code (A2)

drugstructuredosageunit

B.4.k.5.2

Case Form / Products / Dosage Regimens / Dose Units

LM / Dosage Unit / E2B Code

drugcumulativedosageunit

B.4.k.5.7

Case Form / Products / Total Dose to Primary Event

LM / Dosage Unit / E2B Code

drugadministrationroute

B.4.k.8

Case Form / Products / Dosage Regimens / Patient Route of Administration

LM / Routes of Administration / E2B Code

drugparadministration

B.4.k.9

Case Form / Products / Dosage Regimens / Parent Route of Administration

LM / Routes of Administration / E2B Code

drugintervaldosagedefinition

B.4.k.5.5

LM / Dosage Frequency / Unit

LM / Dosage Frequency / Unit

actiondrug

B.4.k.16

Case Form / Products / Product Details / Action Taken

LM / Action Taken / E2B Code

mhlwadmicsrcasenumclass

J.4a

Case Form / Analysis / PMDA / General / Report Category

LM / Reporting Category / E2B Code

mhlwadmicsrnewdrugclass

J.8

Case Form / Analysis / PMDA / Comments / Category of the new drug

LM / License Category / E2B Code

mhlwphaseofstudies

J.12.i.2

Business Configuration / Studies / Study Development Phase

LM / Study Development Phase / E2B Code

3 ICSR Check

In order to successfully transmit any E2B Report, it must validated for its mandatory components before transmitting the report.

3.1 Why perform an ICSR Check

You can run an ICSR check by clicking the ICSR icon from the Quick Launch menu shown below.

Note: The ICSR check icon is visible on the Quick Launch Toolbar ONLY if a case is open and active on the user session.

Running an ICSR check validates if the E2b report has all these mandatory elements present that is required for its successful processing.This check performs the function that prints the ”E2B Report – DTD Length Check Warnings” and ”E2B report – DTD Validation”.

The following illustration shows a sample ICSR check report that is generated in PDF format:

As can be seen in the PDF, the sample report displays the case form fields where the validation error has occurred.

Apart from the case form location where the error occurred, the report lists the type of error, data elements, DTD elements, the actual message/cause of the error, and the profiles which were tested for each validation type.

The validation checks are profile-dependent but every ICSR check report tests for Mandatory Elements check and Mandatory Optional Elements check.

3.1.1 ICSR Validation

This report has 5 main sections:

1. Mandatory Elements

2. Mandatory Elements for Completed Reports

3. Do Not Enter Elements

4. Elements for which English Characters are not allowed

5. Other Validation Errors

4 Transmit and Monitor ICSR Reports

Argus Safety provides utilities that enable you to schedule and transmit E2B reports. Using these utilities, you can also track the status of the transmitted E2B reports. This chapter includes discussions of the following:

- Log In and Out of Argus Safety

- Schedule an E2B Report

- View a Scheduled E2B Report

- Transmit E2B Reports

4.1 Log In and Out of Argus Safety

Before starting Argus Safety, ensure that your company's Argus Safety Administrator of your company has created an account for you and that you have the correct Username and Password for the system. Be aware of the following:

- If you enter an incorrect username or password three (3) consecutive times, the system disables the Login button and displays the following message:
The login button has been disabled due to 3 consecutive incorrect entries of Username or Password. Please refresh the page to enable the Login button.

- The Date/Time format is DD-MMM-YYYY HH:MM:SS to reflect the 24-hour format used by the Web server.

- When you click the name of an enabled/disabled module, the system opens the an Oracle Web site page in a new Internet Explorer window to enable you to access product information:
http://www.oracle.com/us/industries/health-sciences/resources/overview/index.htm#Datasheets

To log in to the Argus Safety application:

1. Open Microsoft Internet Explorer and enter the Uniform Resource Locator (URL) of Argus Safety Web in the Address bar.

2. When the Argus login screen opens, enter your username and password in the appropriate fields.

Note:
Available modules appear in bold text on the log-in screen. Once the system authenticates your log-in information, you will be able to access these modules.

3. Select the appropriate database from the Database drop-down list and click Login.

4. Once the system authenticates your log in, you can access the modules whose names are in Bold text.

4.1.1 To Log Out of the Argus Application

Click Logout on the top-right frame of the window to log out of the application.

4.2 Schedule an E2B Report

Argus Safety enables you to schedule your E2B reports. In addition, it allows you to generate E2B reports that comply with the adverse event reporting requirements of different regulatory agencies.

Note:
When you generate an E2B report, some characters entered by the user in the case form may not be display in the same way in the E2B report. Some characters are represented differently in the E2B report.

To schedule an E2B report:

1. Open a case in Argus Safety and click the Regulatory Reports tab.

2. When the system opens the Regulatory Reports tab, click Schedule New Report.

3. When the system opens the New Expedited Report dialog box, enter the relevant information and click OK.

4.2.1 New Expedited Report Dialog Fields

The Schedule New Expedited Report window has a drop-down list on the top section.

The following table lists and describes the fields in the New Expedited Report dialog box.

Item

Function

Product

Select the Company Suspect Product from this drop-down list.

License Number

Select the particular license for which the report is to be scheduled.

Destination

Select the Regulatory Agency to which the report is to be sent.

Report Form

Select the Report Form from this drop down list.

Message Type

Select the message type from the drop-down list, as configured in Argus Console.
Note: This field is displayed when an E2B report is selected as the Report Form.

Aware Date

List the date when you became aware of the case.
Select the Protect Confidentiality of Reporter and Patient checkbox if you do not wish to disclose the identity of the reporter and the patient of the case.

Group

If you want to assign the report to a specific group, the group can be selected from this drop down list.

Notes

This field is directly mapped to the License but you can modify this field to put in extra notes, as desired.

Cover Letter

You can attach a cover letter with the report, if desired.

Due Date

You can decide to schedule a report to be due in either 5, 15, or 30 days or any number of days or even on any specific date.

New Report

Select this option to schedule a new report.

Non-Reportable Follow-up Report

Select this option to schedule a downgrade report.

Note:
Product, License Number, Destination, Report Form (E2B), and Due Date must be entered in the New Expedited Report dialog to schedule an E2B report.

Note:
The system allows you to generate E2B reports through AG Service irrespective of the your access rights for blinded information. However, the Blind protected users are not allowed to view E2B reports despite having an Argus Interchange license. If such a user tries to view the E2B report, the system generates the message: "Report is generated but system is unable to show the report as user is protected from study information."

4.3 View a Scheduled E2B Report

Use the following procedure to view a scheduled E2B report.

1. In the Regulatory Reports tab, click the row (draft/final) that corresponds to the scheduled E2B Report to generate the report.
The report is generated and can be viewed in the E2B Viewer.If a validation error occurs during E2B report generation, the validation details are stored in the Report Details dialog.

2. Right-click the report icon and select View Report Details to open the Report Details dialog box.

4.4 Transmit E2B Reports

Argus Safety enables you to simultaneously submit multiple adverse event reports to ease the submission process. This section describes how you can use the Bulk Reports by Case and the Bulk Reports by Form features to transmit E2B reports.

4.4.1 Transmit Bulk Reports by Form

Use the following procedure to transmit Bulk Reports by Form:

1. Click Reports ->Bulk Reporting.

2. When the system opens the Bulk Reporting dialog box, enter the appropriate data in the fields.

3. In the Report Form list, select E2B.

4. Under Printing Options, select Transmit.

5. Select the Mark as Submitted check box if it is required to mark the report as "submitted" after the transmission is successful.

6. Click OK after all the required items in the dialog have been entered. Use the table at the end of this topic to understand the function of each item in the dialog.

7. When the system opens the Transmission Comments dialog box, enter the notes for transmission.

8. Click OK to transmit the report(s)
OR

Click Cancel to close the dialog box without transmitting the report.

9. If the Marked as Submitted check box was selected in step 5, the system opens the Report Submission Information dialog box.
Enter the submission notes in the Notes field and click OK.

Note:

If the Marked as Submitted check box was not selected, the Report Submission Information dialog does not appear automatically. In this case, once the report has been successfully transmitted, it can be marked as "submitted" from the Worklist as follows:

Go to Worklist ->Bulk Transmit and verify that the View All radio button is selected.

Scroll in the list to locate the required report. If the report status is "Success", click the report icon and select Mark Report as Submitted.

In the Report Submission Information dialog box, enter the submission notes and click OK.

4.4.2 Monitor ICSR Transmit Statuses

Use the following procedure to monitor ICSR Transmit Statuses:

1. Click Utilities -> ICSR -> ICSR Transmit Status

2. When the system opens the ICSR Transmit Status dialog, enter the appropriate data.

4.4.2.1 ICSR Transmit Status Fields

The following table lists and describes the fields in the ICSR Transmit Status dialog box.

Item

Description

Column Headers

Clicking the column header sort the data by that column alternately in a ascending and descending order.

Agency / Trading Partner

Enables you to filter data by selecting the Agency / Trading Partner from the list.

Transmit Date Range From

The search start date.

Transmit Date Range To

The search end date

Range

A pre-defined date that you select from the list.

Message # Range From

The beginning message number for the search.

Message # Range To

The ending message number for the search.

Type

Enables you to filter data by selecting the pre-defined Type of Message (MSG, ACK) from the list.

Print

Enables you to print the current view.

Search

Enables you to perform the search.

Note:
The EDI Header control number is shown only for EDI files.

1. Select the appropriate agency or trading partner from the Agency/Trading Partner list.

2. Select the appropriate option, Transmit Date or Message # to search by transmit date or by message number.

3. Enter the appropriate search criteria beside the selected option and click Search.

4. In the search results, click the appropriate report.

5. The Message Acknowledgement Status dialog appears.

6. This dialog provides detailed information about the transmission status of the report. Enter the data for each field as required.

4.4.2.2 Message Acknowledgement Status Dialog Fields

The following table lists and describes the fields in the Message Acknowledgement Status dialog box.

Item

Description

ICSR Message #

This is the message number of the transmission from the sender.

ICSR Message Sender ID

This is the sender name or identification.

ICSR Message Date

This is the date and time the sender transmitted the message.

Acknowledgement Message #

This is the acknowledgement message number sent by the receiver.

ICSR Message Receiver Identifier

This is the receiver name or identifier.

Acknowledgement Message Initiated on

This is the date and time the receiver got the message.

Transmission Acknowledgement Code

This code indicates whether the receiver loaded all reports or only a portion of the reports into the database.

Case Number

This is the original case number for adverse event.

Authority Number

If the E2B report originates from a regulatory authority, this is the report identification number assigned by the regulatory authority.

Local Case Number

The system uses this number when it retransmits a message. This is the case number at the local organization that is re-transmitting a report it received.

Other Number

The system uses this number when a report originates from an entity other than a trading partner or a regulatory authority.

Report Status

Report status can be either "Report Loaded" or "Report not loaded".

E2B Report Type

This is one of the following report types:
Initial

Follow up

Nullification

Duplicate

Downgrade

Message

This indicates whether an error message is associated with the transmission or receipt of the report.

4.4.2.3 PMDA ACK Import Logic

E2B (R2) Reports

The MARK AS SUBMITTED logic has been updated for PMDA E2B reports.

The following scenario is being used to explain the requirement,

The PMDA E2B Report and PMDA ACK element are being referred using the Data Element Numbers in the requirement:

PMDA E2B (R2) ACK:

- A.1.6 (TRANSMISSIONACKNOWLEDGMENTCODE)
Possible Values as per ICH:

01= All Reports loaded into database

02= ICSR Error, not all reports loaded into the database, check section B

03= SGML parsing error, no data extracted

- B.1.8 (REPORT ACKNOWLEDGMENTCODE)
Possible Values as per ICH:

01=Report Loaded Successfully

02=Report Not Loaded

- B.1.9(ERRORMESSAGECOMMENT)

The application has been enhanced such that, when an ACK is received against PMDA E2B report with A.1.6 = 01, B.1.8 = 02, the application treats it as a Positive ACK with warning and marks the report as submitted.

The report submission behavior for different combination of ACK's against PMDA E2B Reports is:

- Ack: A.1.6 = 01, B.1.8 = 01 - Positive Ack, Report is marked as submitted

- Ack: A.1.6 = 01, B.1.8 = 02 - Positive Ack with Warning, Report is marked as submitted

- Ack: A.1.6 = 02, B.1.8 = 01 or 02 - Negative Ack, Report is not marked as Submitted.

- Ack: A.1.6 = 03, B.1.8 = 01 or 02 - Negative Ack, Report is not marked as Submitted.

This behavior of marking PMDA E2B Report as submitted against the positive ACK is applicable only when the report submission is set to any of the following values:

- Use MDN Date as Submission Date and Mark report as submitted only on Positive ACKs.

- Use Business Level ACK Date as Submission Date and Mark report as submitted only on Positive ACKs.

- Use Submitted date as entered by the user and Mark report as submitted only on Positive ACKs.

E2B (R3) Reports

A separate ACK profile is available for the PMDA E2B R3 ACK "ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE - PMDA". It consists of all the Export and Import mapping logic in the OOTB Acknowledgment profile.

The following section explains the import of ACK:

1. PMDA Number (B.r.2)

1. PMDA number (B.r.2) element in the PMDA E2B R3 ACK corresponds to the B.1.3 element in the PMDA E2B R2 ACK.

2. PMDA has made some modification to structure/information in PMDA Number that is sent against the E2B R3 report as compared to the corresponding information for PMDA R2 ACK; the PMDA number format for PMDA E2B R3 is:
XX-YYYYYYYY-ZZ

XX: represents the 2 digit E2B (R3) code of reporting category of the original ICSR submitted by the company.

YYYYYYYY: represents the 8 digit unique PMDA ID provided to a successfully loaded ICSR.

ZZ: represents the count of successfully loaded initial and follow-up reports for that case and reporting category. This is sent by PMDA to the company for information purposes only.

3. Application logic for ACK import has been enhanced such that application identifies the ACK that is getting imported is against the PMDA E2B R3 report, the import logic has been enhanced to handle the newly added ZZ component in the such a way that it is loaded in the ESM schema and is available for user to view in the Report Details Dialogue View ACK Acknowledgment Report Tracking # and Bulk E2B Transmit Messages (tab) View Acknowledgment (context menu).

4. The Case Form > PMDA Tab > PMDA Number displays only the 8 digit YYYYYYYY number as it does for the PMDA E2B R2 report.

2. Transmission Acknowledgement Code (A.4) and Acknowledgement Code for a ICSR Message (B.r.6)
The above elements in the PMDA E2B R3 ACK indicate the status of the PMDA E2B R3 report, and the values for the code are in line with that of ICH. For ready reference, below are the values for these elements:

Allowed Values for A.4

- AA - Application Acknowledgement Accept (message successfully processed, no further action)

- AE - Application Acknowledgment Error (error detected, error response has additional detail, some ICSR message(s) need further action)

- AR - Application Acknowledgment Reject (parsing error, no data extracted, re-send the entire transaction)

Allowed Values for B.r.6

- CA - Commit Accept (the ICSR message successfully loaded)

- CR - Commit Reject (the ICSR message contains fatal error that prevents the ICSR from being loaded)

The similar codes A.1.6 and B.1.8 exists in the PMDA E2B R2 ACK file as

Allowed Values for A.1.6

- 01= All Reports loaded into database

- 02 = ICSR Error, not all reports loaded into the database, check section B

- 03= SGML parsing error, no data extracted

Allowed Values for B.1.8

- 01=Report Loaded Successfully

- 02=Report Not Loaded

1. Currently while importing the ACK for PMDA E2B R2 if the ACK File is received such that the value of A.1.6 = 01 and B.1.8 = 02 the application interpret it to ACK with a warning i.e. the PMDA has loaded the report in there system but are some warnings for which a follow-up report is required.

2. As per the PMDA E2B R3 guideline the same warning situation is indicated with A.4 = AE and B.r.6 = CA, and application logic shall be enhanced to handle the warning ACK similar to that of PMDA E2B R2

3. The warming ACK shall be handled across the application not limited to the following locations:
- ACK Import

- Worklist ' Bulk E2B Transmit (Reports & Messages Tab)

- Report Details Dialogue

The following table explains the possible combinations for A.4 and B.r.6 in a PMDA E2B R3 ACK file:

A.4

B.r.6

Results

AA

CA

Positive

AE

CA

Warning

AE

CR

Negative

AR

CR

Negative

AA

CR

Invalid

AR

CA

Invalid

4.4.3 Monitor ICSR Receive Statuses

Use the following procedure to monitor ICSR Receive Statuses:

1. Select Utilities -> ICSR -> ICSR Receive Status.

2. When the system opens the ICSR Receive Status dialog box, enter the appropriate data in each field.

4.4.3.1 ICSR Receive Status Dialog Fields

The following table lists and describes the fields in the ICSR Receive Status dialog box.

Item

Description

Agency / Trading Partner

Enables you to filter data by selecting the Agency / Trading Partner from the list.

Receive Date Range From

The search start date.

Receive Date Range To

The search end date.

Range

Enables you to select a pre-defined date range

Message # Range From

The beginning message number for the search.

Message # Range To

The ending message number for the search.

Type

Enables you to filter data by selecting the pre-defined Type of Message (MSG, ACK) from the list.

Control #

The control number.

Local Msg #

The local message number.

Remote Msg #

The remote message number.

Total Reports

The total number of reports.

Rejected Reports

The number of rejected reports.

File Name

The name of the received file.

Received from EDI

The date and time the file was received.

Transmission Status

The transmission status for the file.

Print

Enables you to print the current view.

Search

Enables you to initiate the search.

Note:
The EDI Header control number is shown only for EDI files.

1. Select the appropriate agency or trading partner from the Agency/Trading Partner list

2. You can search for the receive status by either receive date or message number. Select the appropriate option among Transmit Date and Message #.

3. Enter the appropriate search criteria beside the selected option and click Search.

4. In the search results, double-click the appropriate report.

5. When the system opens the Message Acknowledgement Status dialog, enter the appropriate data in each field.

4.4.3.2 Message Acknowledgement Status Dialog Fields

The following table lists and describes the fields in the Message Acknowledgement Status dialog box.

Item

Description

ICSR Message Number

This is the sender's transmission message number.

ICSR Message Sender ID

This is the sender name or identifier.

ICSR Message Date

This is the date and time the sender transmitted the message.

Acknowledgement Message #

This is the receiver's acknowledgement message number.

ICSR Message Receiver Identifier

This is the receiver name or identification.

Acknowledgement Message Initiated on

This is the date and time the message was received.

Transmission Acknowledgement Code

This indicates whether the receiver loaded all transmitted reports or part of the transmitted reports into the database.

Case Number

This is the original case number for adverse event.

Authority Number

If the E2B report originates from a regulatory authority, this is regulatory authority's report identification number.

Local Case Number

The system uses this number when it retransmits a message. This is the case number at the local organization that is re-transmitting a report.

Other Number

The system uses this number if the report originates from an entity other than a trading partner or a regulatory authority.

Report Status

Report status can be either "Report Loaded" or "Report not loaded."

E2B Report Type

This is the report type. It can be one of the following
Initial

Follow up

Nullification

Duplicate

Message

This indicates whether an error message is associated with the transmission or receipt of the report.

4.4.3.3 Validation Check of Incoming Message

Prior to updating the transmission status of the reports, the application identifies the type of incoming message and validates the incoming message. The E2b service processes all the incoming messages located in a folder either in incoming EDI directory or physical media directory. Incoming E2b Messages are retrieved as SGML from a shared directory. The incoming folder is configurable in INI file. E2b message is parsed to check the validity of the SGML file using the correct version of DTD. The incoming message is saved after checking that message is in compliance with DTD.

The recipient of the E2b message acknowledges receipt of message and notifies the sender about the validity and usability of the data in the reports. The acknowledgment message is called as ICSR Acknowledgment Message. When a message is acknowledged, workflow status of the E2b report is updated with one of the following three status:

- All reports loaded into recipient database

- ICSR Error, not all reports loaded into database

- SGML parsing error no data extracted

The acknowledgement contains two sections, one concerning the validity of the message as a whole and the second containing comments on the validity of the individual reports within the message. Create a folder and configure the INI file where all the incoming messages can be stored. The E2b service processes the received message and copies it in the incoming Physical media folder.

The message is validated based on the ICH ICSR acknowledgement specifications and the format of the message identified by DTD version. Correctness of receiver and sender identifier present in the message header is also validated to verify that the message is not sent to the wrong recipient.

The content of the message is validated based on the following:

- Required Data

- Data Type

- Data Length

- Field Value

The system identifies message type (acknowledgement) and the DTD version of the message. If the application is unable to identify the message type or DTD version, then the error is logged in the log table and further processing is stopped. The application sends an email to configured email address indicating the failure to read the message.

Application checks for the presence of the duplicate in the system based on the &rsquor;Sender identifier' and &rsquor;Acknowledgement Message Tracking #'. Processing of the acknowledgement is stopped, if duplicate message is found in the database and an error is logged into the log table.

The following table describes the error messages and reasons for the occurrence of corresponding errors.

Process

Error message

Possible Reason of error

Read the Incoming message from the folder

XML File not in path.

File is removed.

Identification of the incoming message type

<<File Name>> not a valid XML File

File format is not as per ICH guidelines.

Identification of the incoming message type

Not valid ICH ICSR message Tag &rsquor;<ichicsrmessageheader>' not found

File does not contain the valid ICH Message Header.

Identification of the incoming message type

Failure to identify the type of incoming message. Either Tag <messagetype> is missing/misspelled or tag does not contain valid value. The valid values are ICHICSR, ICHICSRACK

The incoming file is identified as a message or acknowledgment. The identification value is wrong.

Identification of the incoming message type

Record not found in CFG_PROFILE table for DTD version '2.1', DTD release '1.1', Active profile = 'Y' and profile type starts 'ACK%'

Profile does not exist in cfg_profile table.

Validation of the incoming message type

M2 Validation failed for incoming message. The following are the elements and values:<<Element, value>>

M2 validation failed on the message header.

Identification of the incoming acknowledgement type

Not valid ICH ICSR message Tag &rsquor;<messageacknowledgment>' not found

File does not contain the valid ICH Acknowledgment Header.

Processing acknowledgment

Record not found in MESSAGES table for the ICSRMESSAGE number <<MessageNum>> ICSRMESSAGE receiver identifier <<receiver info>> for the received acknowledgment

Record is deleted from the database.

Processing acknowledgment

Duplicate acknowledgment received for ICSRMESSAGE number <<message number>> and ICSRMESSAGE RECEIVER IDENTIFIER <<receiver info>>

Acknowledgment already exists for this message number.

Processing acknowledgment

<reportacknowledgment> section is missing from the received acknowledgment, MESSAGE number <<message number>>

Acknowledgment does not contain the report acknowledgment body.

Processing acknowledgment

Record not found in SAFETYREPORT table for company number <<Company Number>> and msg_id <<message id>>

Record is deleted from SAFETYREPORT table from database.

Refer to the sample email messages that are sent to the configured email address in case of message validation failure:

- In case of invalid XML format:
From: E2b service user

Subject: <<file name>> not valid XML formats file

Content: This mail has been sent by the system to notify that the system has failed to identify the file <<file name>> as a valid XML file.

Error has occurred on Line: <<line no>>, Source Text <<Error Text>>, Error Code <<Parsing Error Code>>, Error Reason <<Error Reason>>

Thanks,

<< E2b service user >>

- In case the application fails to identify the incoming message:
From: E2b service user

Subject: Failure to Identify the Type of Incoming Message.

Content: This mail has been sent by the system to notify that the system has failed to identify the type of the incoming message (Acknowledgement or a Message) present in the file <<Incoming Message File Name>>.

Thanks,

<< E2b service user >>

- In case of validation failure of the incoming acknowledgement:
From: E2b service user

Subject: Validation Failure of the Incoming Acknowledgement.

Content: This mail has been sent by the system to notify that the system has failed to further process the incoming acknowledgement present in the file <<Incoming Message File Name>>.

The following are the reasons for this failure:

#<n>. <<Insert the corresponding relevant error message.>>

Thanks,

<< E2b service user >>

You can view the acknowledgement information of a report such as acknowledgement message tracking #, acknowledgement report tracking #, date acknowledge initiated, company ICSR message, and error reported by receiver, in the Report Details dialog.

The status of the each E2b report is updated based on the information extracted from the ICSR acknowledgment, irrespective of the transmission status (Success or Failure). Refer to the section "View Acknowledgement Information" for viewing the acknowledgement information.

4.4.4 Nullification Reports

The system can automatically schedule, generate, and transmit a Nullification Report under the following circumstances:

- When a case is deleted and an E2B Report is submitted to a reporting destination based on the Profile switch for sending E2B nullifications.

- When an E2B report is submitted and marked as unsubmitted from Reports | Compliance | Submitted Reports:

- The Reason for Unsubmitting the report is sent as the nullification reason for the report.

- If the user selects the Send Nullification on Unsubmission of E2B Reports check box, the system also sends a nullification to the reporting destination where the E2B Report was previously submitted.

- If the user does not select the Send Nullification on Unsubmission of E2B Reports check box, the system does not send a nullification to the reporting destination where the E2B Report was previously submitted unless the user deletes the case.

- If a previous nullification for the E2B Report or an unsubmitted report is sent for a case and the case is deleted at a later date, the system does not send a duplicate nullification for the previous report.

- When the system generates the Nullification report, the system updates the following E2B items with updated values from the previous report.

Updated E2B Items

Update Content

M.1.4

System uses a different unique number from that used in the last report.

M.1.7a

System enters the message date format.

M.1.7b

System enters the message date.

M.2

System increments this value every time it transmits the report.

A.1.3a

System enters the message date format.

A.1.3b

System enters the message date.

A.1.13

System enters 1=Yes on the Nullification report.

A.1.13.1

System enters the reason for the Nullification report.

- When you accept a Nullification report, the system creates an Action Item in the case. The action item tells you that the system will delete the case if you click OK on the acceptance dialog for all unarchived cases.

- Action Item is a type ahead field and its default is blank.

- The field is populated with values from the action item configured in the code List.

- You can assign the number of days until the action item is due in the Due In field. The system enables this field after you select an Action Item type.

- The system calculates the due date as follows: System Date (local client date) + Due In number of days.

- The system puts the System Date (local client date) in the Date field.

- When creating the action item, you can select a value from the Code List and the Action Item Description. The system uses the following format: Nullification: xxx
where:

xxx is the value entered in the Notes field.

- By default, the system assigns the action item to the user group in the User Group field.

- There can be a maximum of 25 user groups in the drop-down list.

- The system performs a like search when you select a value in the User Group field.

- If the User Group field is blank, the system does not assign the action item.

- This is enabled after you select an action item.

- If you do not select an action item, the system does not create an action item for the case.

- If you accept multiple cases, the system creates action items for all accepted cases.

- The system skips open, locked, or archived cases or cases you don't have permission to access.

- If the system archives a case while you are accepting the nullification report, the system displays the Archived Case dialog to enable you to open the archived case.

- After you reopen the case, the system displays the Accept Nullification E2B dialog.

- If you do not have permission to reopen an archived case, the system displays the following message:
You do not have permission to Re-Open an archived/closed case.

4.4.5 View Statuses

Argus Safety provides the feature to monitor the transmission status of E2B reports.

Use the following procedure to check the status of transmitted E2B reports.

1. Select Worklist -> Bulk ICSR Transmit.

2. Click the Bulk ICSR Transmit tab to view the status of transmitted reports.

Note:
Viewing the transmission status of E2B reports is a feature available only in Argus Safety Web.

4.4.6 View Acknowledgement Information

In Argus Safety, you can view detailed acknowledgement information for a report sent to a trading partner or a regulatory authority. Use the following procedure to view acknowledgement information.

The status of each report is updated, based on the information extracted from the ICSR acknowledgment, irrespective of the transmission status (Success or Failure).

The acknowledgement information such as acknowledgement message tracking #, acknowledgement report tracking #, date acknowledge initiated, company ICSR message and error reported by receiver is displayed in the Report Details dialog.

1. On the Regulatory Reports tab of the Case Form, click the E2B report and select View Report Details.

2. When the system opens the Report Details dialog, click View ACK Information to view the acknowledgement details for that report. If the report is rejected, an error message or a comment appears in the Notes area of the dialog
When the Acknowledgement Information dialog opens:

Click Print to print the acknowledgement details

OR

Click OK to close the dialog box.

5 Use the ICSR Viewer

The ICSR Viewer enables you to open E2B files and view them in different formats. You can print these files from the ICSR viewer.

5.1 Open the ICSR Viewer

The ICSR Viewer enables you to view your E2B reports in the following views. A new switch is added to identify the default viewing format of the PMDA E2B R3 report in the ICSR viewer.

View

Description

SGML

Displays the E2B report in the SGML format. This view is applicable for non-Japanese E2B reports.

Decoded View

Displays all the E2B elements in groups and subgroups. Elements eligible for decoding with their decoded values in parentheses.
Decoded View supports the following Argus J specific views for Japanese E2B reports:

- I - Decoded View

- J - Decoded View

I and J Decoded Views display following information on the screen in Japanese language:

- Field Labels on the screen

- Folder Tree Values

- Decoded description values wherever there is a text.

In this view, the application lists the ICH and PMDA element in the decoded formats as per the applicable decoded value based on the allowed values set for the element against the profile. Besides, the element number and decoded element description (both English and J) are based on the "Data Additional Information Tab Case Form 1-28 Element R3" and Title/J Title respectively as per PMDA E2B R3 Mapping.

CIOMS

For details on the CIOMS view, refer to the "E2BCIOMSMapping" document. This view is applicable for non-Japanese E2B reports.

HL 7 View

In this view, the application opens the report within the HL7 message format as per the PMDA Guidance ( as explained in the report generation section).

MedWatch

For details on the MedWatch view, refer to the "E2BMedWMapping" document. This view is applicable for non-Japanese E2B reports.

I-SGML

Displays ICSR I data items in SGML format.

J-SGML

Displays ICSR J data items in SGML format.

I-Decoded

Displays the Decoded view for all the I elements of a PMDA E2B report.

J-Decoded

Displays the Decoded view for all the J elements of a PMDA E2B report.

PMDA Report Form

Displays the appropriate PMDA form, as per the reporting category.

Native XML View

In native XML view, the application lists all the ICH and PMDA specific elements as per the PMDA E2B R3 Mapping.

You can also view the E2B Report from the Argus Safety application.

Click the Draft or Final status for a report in the Regulatory Reports tab of Case Form.

5.1.1 PMDA E2B Report Mapping

Companies often send the expedited case reports to PMDA through E2B XML transmission over a specified gateway. The E2B Report adheres to the guidelines provided by the PMDA in conjunction with the ICH, which the Argus Safety Applications need to follow.

The PMDA profile E2B transmission logic for SERIOUSNESS [A.1.5.2] tags considers on those events which have been included in the PMDA E2B based on event reportability criteria. This is applicable to the following tags:

1. SERIOUSNESSDEATH

2. SERIOUSNESSLIFETHREATENING

3. SERIOUSNESSHOSPITALIZATION

4. SERIOUSNESSCONGENITALANOMALI

5. SERIOUSNESSDISABLING

6. SERIOUSNESSOTHER

The E2B transmission logic for SERIOUSNESSDEATH tag which currently looks at death details even though it is not related to any event included in the E2B has been removed. It is transmitted as 1 (Yes), only if at least one event which is included the E2B report has Death associated with it. Otherwise, it will be transmitted as 2.This is applicable to all E2B profiles - ICH, FDA, EMEA and PMDA.

The transmission logic for SERIOUSNESSDEATH tag has been removed. It is transmitted as 1 (Yes), only if at least one event which is included the E2B report has Death associated with it. Otherwise, it shall be transmitted as 2.This is applicable to all E2B profiles - ICH, FDA, EMEA and PMDA.

All the E2B check validations for all profiles - ICH, FDA, EMEA and PMDA, related to the following tags will be corrected to only refer to seriousness of the events which are included in the E2B report:

1. SERIOUS

2. SERIOUSNESSDEATH

3. REACTIONOUTCOME

For PMDA E2B reports, if there are no reportable events for the E2B / PMDA Paper Reports, then instead of opening PMDA ICSR Validation Report with missing mandatory tag errors for REACTIONMEDDRAPT and REACTIONMEDDRALLT tags, application shall display an Argus standard messagebox with OK button and error message: No reportable event exists for the report.

Note:
For additional details, refer to the PMDA E2B Report Mapping Guide that is part of the Technical Reference Manual, as part of this release.

5.2 Export an SGML File

The system enables you to use the following procedure to export an SGML file.

1. Click the Final E2B report type on the Regulatory Reports tab.

2. When the system opens the E2B Viewer window, Select SGML from the View Format drop-down list.

3. When the system displays the contents of the SGML file, click Export.

4. When the system displays the SGML report, click File -> Save As.

5. When the system opens the Save As dialog box:

1. Enter a name for the file.

2. Browse to the folder where the file is to be saved

3. Click Save to save and export the SGML file.

Note:
Exporting an E2B report can only be done from the SGML view on final reports. If you select draft, the Export button becomes unavailable

6 Import ICSR Reports

6.1 Incoming ICSR Reports

Incoming ICSR Reports can be viewed from the Incoming ICSR Report screen. This section includes discussions on the following:

- Search for Duplicate Cases

- Use the View Differences Report

- View the E2B Report

- Accept Single/Multiple E2B Reports

- E2B Initial/Follow-up Intake

- E2B Follow-up Acceptance for Closed/Locked Cases

- Source XML Received for the Case

- Import E2B (R3) Messages

- ICSR Pending Screen for (R3) Report

6.1.1 Search for Duplicate Cases

The Duplicate Search dialog for E2B report allows you to search for possible duplicate cases in the Argus Safety system. You can select different combinations of search criteria. When more than one criterion is selected, only cases that satisfy all criteria are listed. By default, only the fields that are present in the E2B Report are checked for the Duplicate Search.

Use the following procedure to perform a duplicate search.

1. Select Reports -> ICSR Pending Report.

2. When the system opens the Incoming E2B Reports dialog, right-click a case to perform a duplicate search.

3. The system displays the search results at the bottom of the dialog box.

6.1.1.1 Duplicate Search Dialog Box Fields

The following table describes the fields present in the Duplicate Search dialog.

Field

Description

Agency

The name of the primary agency.

Original Case Number

The submitter's original case number.

Message Number

The case message number.

Product Name

The name of any product on XML.

Generic Name

The active substance on XML.

Report Type

The type of report.

Study ID

The unique value that identifies the study.

Receipt Date

The date Argus received the report and saved it in the system.

Center ID

The ID of the center.

Sal.

The salutation, such as Mr. or Mrs.

Suffix

The suffix, if applicable, that follows the name (e.g., Jr., Sr.,III, etc.)

First Name

The first name of the patient.

Last Name

The last name of the patient.

Country of Incidence

The country where the incident occurred.

State

The state where the incident occurred.

Postal Code

The postal code of the area where the incident occurred.

Patient Name

The name of the patient.

Event Desc.

A description of the adverse event.

Initials

The initials of the patient.

Onset Date

The date from the first reaction or adverse event occurred.

Pat. ID

The unique value that identifies the patient.

Age/Units

The age of the patient.

Pat. DOB

The patient's date of birth.

Gender

The gender of the patient.

Reference #

National Regulatory Authority's Report Number, used as a Reference Number.

Journal

The journal name of the literature reference.

Keyword

Select the check box and enter a keyword to be searched, if required.

Title

Select the check box and enter a title to be searched, if required.

Nullification Reason

The reason the case was nullified.

Accept Initial E2B as Follow-Up

Enables you to accept initial E2B as a follow-up to an existing case.

Search

Finds results matching the specified search criteria.

View E2B

Enables you to view the E2B report.

Accept E2B Case

Enables you to accept an E2B case.

Reject E2B Case

Enables you to reject an E2B case.

View Warning

Enables you to view warnings associated with the case.

View Differences

Enables you to view the differences between the XML to be imported (a message that is not yet imported into the database), the current case data in the database, and the last imported case.
Note: This button is available only for follow-up and nullification reports.

Case Number

The case number of the case matching the search criteria.

Pat. Initials

Displays the initials of the patient in the case matching the search criteria.

Action

Enables you to view the Case Summary dialog.

Project ID

Displays the Project ID of the case matching the search criteria.

Study ID

Displays the Study ID of the case matching the search criteria.

Date

Displays the date of the case matching the search criteria.

Country

Displays the country name of the case matching the search criteria.

Product

Displays the product name involved with the case matching the search criteria.

Event

Displays the event involved with the case matching the search criteria.

Report Type

Displays the report type of the case matching the search criteria.

Reporter

Displays the reporter involved with the case matching the search criteria.

Note:
The search output is displayed in the Total Number of Rows section. You can click the Action icon to view the Case Summary dialog.

6.1.2 Use the View Differences Report

The View Differences Report enables you to view differences between the following:

- The current XML being imported (a message not yet imported into the database)

- The current case data in the database

- The last imported case.

Click View Differences from the Duplicate Search screen to view the View Differences report. View Differences is available only for follow-up and nullification reports only.

The following table lists and describes the fields in the View Differences report:

Field

Description

Trading Partner

Enables you to view the name of the Trading Partner sending the E2B report.
Note: The Lock/Archive icon displayed with this field indicates the status of the case.

DTD Version

Enables you to view the DTD version of the follow-up E2B report.

Case Number

Displays the sender's original case number for the E2B report.

Follow Up #

Displays the sequence number of the follow-up for the E2B report.

Total Number of Rows

Allows you to select the type of E2B Difference to view from:
Current E2B vs. Current Case in Database

Current E2B vs. Last Imported E2B

Current Case in Database vs. Last Imported E2B

Import

This check box highlights import differences.

E2B Element

Refers to the data elements in the incoming E2B report or in the existing report.

Current E2B

Refers to the data in the incoming XML that has not yet been accepted in the current E2B.

Current Case in Database

Refers to the data in the current case in the database.

Last Imported E2B

Refers to the data showing the last imported E2B.

Accept Follow-up

Allows you to accept follow-up reports with the corresponding fields selected for import.

Reject Follow-up

Enables you to reject follow-up reports for import.

Print List

Provides the difference report in a PDF format.

Close

Enables you to close the window.

6.1.2.1 Displaying Differences

The differences in the E2B reports are displayed in the following manner:

- Addition - New elements on incoming XML are highlighted in grey.

- Deletion - Deleted elements are highlighted in red.

- Modification - Modified elements are highlighted in yellow.

For PMDA R3:

- The Difference report viewer lists all the ICH and PMDA regional elements in one single view similar to that of EMA R3 (unlike the PMDA E2B R3 where there were two I and J views).

- All the concepts for the R3 import frameworks such as deletion, primary key matching of the records, and custom comparison logic are also available for PMDA E2B R3 ICSR import.

6.1.3 View the E2B Report

Use the following procedure to view the E2B Report:

1. Select Reports -> Duplicate Search and right-click to the Duplicate Search dialog box.

2. Click View E2B to view the E2B report in the ICSR Viewer.

6.1.4 Accept Single/Multiple E2B Reports

Use the following procedure to accept single and multiple E2B reports:

1. Select Reports -> E2B Pending to open the Incoming ICSR Report dialog box.

2. When the system opens the Incoming ICSR Report dialog box:
Select Accept ICSR to accept a single report

OR

Select the check boxes for each report and click Accept ICSRs to accept multiple reports.

3. When the system opens the Acceptance of Initial Report Confirmation dialog box, enter the password and any relevant notes.

4. Click OK to accept the case.

Note:
Accept ICSRs can be performed only when the system numbering is set to Automatic.

5. If the system is configured to automatically number cases, the system opens the case accepted dialog appears with the generated case number.

6. Click OK to close this dialog.

Note:
If the system is configured to manually number cases, you will be prompted to enter a case number for the case that is being accepted.

For PMDA R3:

The case acceptance procedure supports the batch import of the R3 message (unlike PMDA E2B R2).

6.1.5 E2B Initial/Follow-up Intake

During case acceptance, you can access selective acceptance fields in the report.

- The Selective Acceptance feature is enabled only for single initial ICSRs and is a right-click option.

- If you select multiple ICSRs, the system disables this button.

- If you select a single follow-up or nullification ICSR, the system disables this button.

- When the system displays the E2B Difference Report dialog, you can select the elements required to create or update a case without the system displaying the Case Number and Follow-up Number in the difference report dialog for initial reports.

- The following changes have been made to the Initial Intake and the Follow-up Difference Report dialogs:

- The system displays the decoded view to enable you to select the elements (e.g., US [United States]).

- The system prints the check box options for the Initial Intake and Follow-up Difference Report dialogs.

- The label is updated to Select when selecting elements for the Initial Intake and the Follow-up Difference report dialog.

- You must select the following fields before the system will permit you to accept the Initial case. By default, all the fields are selected.

- Country of Incidence (default and grayed out)

- Report Type (default and grayed out)

- Initial Receipt Date (default and grayed out)

- Any one Product

- Any one Event Term

- If you fail to select these fields, the system displays the following message:
E2B cannot be imported as it does not meet minimum Argus requirements.

- The system permits you to print the Initial ICSR report.

- When you click Accept Initial, the system displays the Accept E2B Case dialog. When you complete the data elements and click OK, the system displays the Error/Warning message dialog for any elements you have selected.

- Once you accepts the case as an initial or follow-up case, the system attaches the Source XML (ICSR) and the Initial Selection PDF to the case in the Additional Info tab.

- Initial/Follow-up Source XML

- Attachment Classification. As specified in the Reporting Destination for the XML source classification.

- Date. The system date when the case you accepted XML for the case.

- Description. The acceptance notes you entered for XML.

- When you click the Source ICSR, you can see the ICSR when opening the ICSR View (E2B Viewer).

- Initial Selection PDF

- Attachment Classification: As specified in the Reporting Destination for the Selection Source Classification.

- Date: The system date when you accepted XML for the case.

- Description: The date you entered acceptance notes for XML.

- Follow-up Source XML

- When you click the Source ICSR PDF or the E2B Difference Report, you can view the Initial Selection PDF or the E2B Difference Report in a different IE window.

- Once you accept a case as an initial or a follow-up ICSR, the system prefixes the Business Level Acknowledgement Notes with the case number in the following format:
Imported Case #: XXXXXX

where:

XXXXXX is the case number

- The system attaches the current notes sent in the Business Level Acknowledgement.

- If the system receives the ICSR via the physical gateway (configured at the reporting destination level), the system sends a low level ACK to indicate the file was received by the Argus Interchange Service.

- For Auto Accepted ICSRs, the system does not attach the source PDF in the case because the source XML is attached.

- The system places this file in the Physical Out folders as configured for the reporting destination in the E2B Mapping Configuration.

- For EDI received files, the system continues to let the EDI Gateway send the low level ACK as it does currently.

- The Interchange Services does not process the low level ACK received in the Physical In destination folder, but enters any errors in the log file since the file will always be rejected by the Interchange Service.

6.1.6 E2B Follow-up Acceptance for Closed/Locked Cases

- If you try to accept follow-up information for a closed or locked case, the system prompts you to unarchive or unlock the case for processing after entering the password and acceptance notes.

- If the system archives a case while you are accepting the report, the system displays the Case Re-open dialog to enable you to open the case.

- If the system locks a case while you are accepting a report, the system displays the Case Unlock dialog to enable you to unlock the case.

- After the you reopen the case, the system accepts all updates as defined in the follow-up information you selected.

- If the you do not have permission to reopen an archived or locked case, the system displays the following message:

- You do not have permission to Re-open an Archived/Closed case or Locked Case.

- If you select multiple open, locked, or archived cases or if you do not have permission to open the case, the system skips the cases.

- The system does not create follow-up actions for cases that it accepts automatically.

6.1.7 Source XML Received for the Case

Once Argus accepts a case as an initial or follow-up case, the system attaches the source XML (ICSR) and the Initial Selection PDF to the case in the Additional Info tab as follows:

- Initial/Follow-up Source XML

- Attachment Classification &endash; As specified in the Reporting Destination for XML Source Classification.

- Date &endash; The system date when the user accepted the case for XML.

- Description &endash; The acceptance notes entered by the user for XML.

- When the user clicks the Source ICSR, the system permits the user to view the ICSR by opening the ICSR Viewer (E2B Viewer).

- Initial Selection PDF

- Attachment Classification. As specified in the Reporting Destination for Selection Source Classification.

- Date. The system date when you accepted the case for XML.

- Description. The acceptance notes you entered for XML.

- Follow-up Source XML

- When you click the Source ICSR PDF or the E2B Difference Report, the system enables you to view the Initial Selection PDF or the E2B Difference Report in a different IE window.

- When you accept the case as an initial or follow-up ICSR, the system inserts the case number before Business Level Acknowledgement Notes in the following format: Imported Case #: xxxx

- If the system receives the ICSR via the physical gateway, it sends a low level ACK to indicate that the file was reviewed by Argus Interchange Services.

- The system places the file in the Physical Out folders as defined in the reporting destination configured in the E2B Mapping.

- When the system receives files from EDI, the system continues to let the EDI Gateway send the low level ACK.

- The Interchange Services does not process the Low Level ACK in the Physical In destination folder but enters any errors in the log file because the file will always be rejected by the Interchange Service.

6.1.8 Import E2B (R3) Messages

- The import process for PMDA E2B R3 imports a single xml file similar to that of a EMA R3 message (unlike PMDA E2B R2 which consists of two files I & J).

- ICSR Import logic for PMDA E2B R3 enables you to import an incoming ICSR file using PMDA E2B R3 profile that consist of only ICH elements i.e. if there are only the ICH elements present in the incoming message, the files would still be imported for ICH elements.

- In the incoming ICSR message for both PMDA E2B R2 and R3, if there is no J2.1a (for R3) and J.4a(for R2) value in the incoming ICSR message then it is considered as Marketed ADR report, and either domestic or foreign is decided based on the COI identified on the data in the incoming ICSR (Primary reporter country or the Reaction occur country).

- Similar to that of PMDA E2B R3 export (same as ICH and EMA) the incoming PMDA E2B R3 messages is expected to be in UTF-8 format rather than the Shift-jis. In case of PMDA E2B R2 (in Argus the encoding is governed based on the Reporting Destination configuration).

- The following are the PMDA E2B R3 specific rules applied to validation logic during import of PMDA E2B R3 file:

- During validations, the special internal logic of considering the Nullification report as Completion Report (J2.7.1-MHLWADMICSRCOMPLETECLASSR3="completed") is considered applicable for PMDA E2B R3. Additionally, the same logic is extended for the Downgrade report for the PMDA E2B R3 message.

- The following is the Minimum case creation validation logic for Reaction for PMDA E2B R3 Research & measure (AE, AF, DE,DF, BC, BD, AG, or DG) category of report:
If the incoming file does not comprise a Reaction than a Dummy relation is used during executing the minimum case validation.

(For details on the profile switch, refer to Oracle Argus Japan Administrator's Guide).

(For details on minimum case validation, refer to Oracle Argus Interchange User Guide (English), section ICSR Import Framework.)

- The following is the COI Identification logic for Minimum case validation:
If Reporting Category is AE, AF, DE, DF, BC, BD, AG, or DG, then fetch the value based on the availability in the following order:

a. Fetch COI from the Primary Reporter C.2.r.5= 1.

b. Fetch COI from E.i.9.

c. Fetch the country from the First reporter which has valid C.2.r.3 value.

- In the incoming PMDA E2B R3 message file the following date elements might contain the time zone component. In case these date elements contain the time zone offset, then adhere to that time zone offset in the element value while converting it in the GMT.

- J2.2.1 - Date of Reporting

- N.1.5 - Date of Batch Transmission

- N.2.r.4 - Date of Message Creation

- C.1.2 - Date of Creation

- C.1.4 - Date Report Was First Received from Source

- C.1.5 - Date of Most Recent Information for This Report

Argus supports time component for N.1.5, N.2.r.4, and C.1.2 only.

In case C.1.4, C.1.5, and J2.2.1 values are in CCYYMMDD precision i.e. without the time component then consider the incoming value to be in GMT and store it without any transformation.

Sample date formats:

- 23-Jan-2017 08:30 +3.5
EMA & PMDA: +3.5 for converting it to GMT: > If Argus support's time, then save the converted date.> If Argus does not support's time, then strip the time from converted date, and save.

- 23-Jan-2017 08:30
EMA & PMDA:

> If Argus support's time, then save the incoming date as-is.> If Argus does not support's time, then strip the time from as-is date, and save.

- 23-Jan-2017
EMA & PMDA: Save the date as-is.

- PMDA E2B R3 regulation have introduced as a new concept of Urgent Report (J2.3 (MHLWFLAGFORURGENTREPORT) = 1). The Urgent Report is treated as regular initial or a follow-up report as applicable.

- The application logic for attachment import supports the compression algorithm as per the profile switch "Compression algorithm for file attachments in PMDA E2B R3".

- Similar to that of EMA E2B R3, if the Reporting destination is configured to transmit the Attachments then the PMDA E2B R3 import logic imports all the valid attachments that are allowed to be added into the case form as configured in the profile switch "Case Processing > Valid Attachment File Types".

6.1.9 ICSR Pending Screen for (R3) Report

- Pending screen filter displays an additional value "Urgent Report" in the existing Reports> ICSR Pending > Report type drop-down list.

- The search grid indicates the Urgent reports by appending "(Urgent)" in the "Initial / F-U / Nullification/ Amendment" column after the actual report type. For example, if the Initial report is an urgent report then the column value is displayed as "Initial (Urgent)".

- In the Pending screen context menu, the E2B Viewer displays the same options as in PMDA E2B R3 Report export i.e. it supports the viewing of the PMDA Paper report. Besides, the default view settings for E2B Viewer remains same as for PMDA E2B R3 export.

6.1.10 PMDA E2B R3 ACK

- PMDA E2B R3 Acknowledgment Template profile "ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE - PMDA" is available in the application.

- Similar to EMA R3, PMDA E2B R3 supports Batch Acknowledgement transmission. The acknowledgements pertaining to ICSR received in the batch are sent only after processing all the ICSRs present in the XML file.

- The application supports the generation of the low level ACK for the PMDA E2B R3 ICSR message imported in Argus using physical media option at Agency level.

- The application generates PMDA E2B R3 ACK as an XML file with the following file name format (unlike PMDA E2B R2 where it was a SGML):
A-<Company's Abbreviation>-<Date of Reporting>-<unique number>.xml

Attribute

Description

Company's Abbreviation

Code List > Reporting Destination > EDI Tab> Company Identifier

Date of Reporting

System date in Japan Time zone (using profile switch JPN_OFFSET) "YYYYMMDDHHMIss" format.

Unique number

This unique number must be alpha-numeric value constructed by concatenating the Case Number and last 2 characters of SAFETYREPORTID tag value (i.e. AA, AB, and AC etc.).For example if the case number is "15JP000236" and Safety Report ID is "JP-SENDER-JAPAN-15JP000236AA" then the Unique number will be "15JP000236AA".In case of a batch ACK, use the case number form the first case of the batch.

6.2 Processed ICSR Reports

The Processed ICSR Reports screen contains a list all processed ICSR Reports. Click the Processed ICSR Reports tab on the Incoming Reports screen to view the Processed ICSR Reports screen.

The Processed ICSR screen contains the following:

- Search Criteria

- Total Number of Rows

6.2.1 Total Number of Rows Fields

The following table lists and describes the fields in the Total Number of Rows section on the Processed ICSR screen.

Field

Description

Originated Case#

Displays the Originated Case Number of the case.

Initial/F-U/Nullification

Displays the Initial/F-U/Nullification status.

Trading Partner

The name of the trading partner.

World Wide Unique#

The World Wide Unique # for the case.

Import Status - Warnings/Errors

The import status of the case and any associated warnings/errors.

Case # Imported As

The Case Number used when importing the case.

Accepted / Rejected By

Identifies who accepted or rejected the case.

Notes

The case notes.

Interchange Date

The Interchange Date.

Date Imported/Rejected

The date the case was imported/rejected.

ACK Gen

Yellow indicates the case is still pending
Orange indicates the case is accepted with warnings / errors

Red indicates the user or system rejected the case.

Green indicates the case has been successfully imported.

EDI Out

Yellow indicates the system is waiting to send the report out of the EDI / XML or PHY out folders
Green indicates the report is already sent out of the EDI / XML or PHY out folders

Red indicates that the EDI gateway failed to send the report out of the EDI / XML or PHY out folders.

Glossary

Electronic Format

A document stored on the computer, instead of printed on paper.

Encode

To convert data by the use of a code in such a manner that reconversion to the original form is possible.

Field Description

Information that describes the characteristics of data in a field.

Field Format

A format in which the output consists of structured field introducers and variable data rather than output in line format.

Filter

A device or program that separates data, signals, or material in accordance with specified criteria.

Home Page

The top-level Web page of a portal. Sometimes used as a synonym for default portal page.

Periodic Safety Update Report

The Periodic Safety Update Report (PSUR) is required as part of the FDA Post Marketing Drug Risk Assessment (PMDRA) program. The PSUR software is designed to track the submission of Periodic Safety Update Reports by marketed product and country.

Portable Document Format

Portable Document Format (PDF) is a file format proprietary to Adobe Systems for representing two-dimensional documents in a device independent and resolution independent fixed-layout document format.

Query

A request for information from the database based on specific conditions. For example, a request for a all reports related to a particular study.

Report

A formatted presentation of information relating to a model or to process simulation results. Reports can be viewed online, printed, or exported to a variety of file formats.

Report Type

A data source and how it is mapped.

Rich Text Format (RTF)

A document file format developed by Microsoft for cross-platform document interchange.

Spontaneous Report

A communication from an individual (e.g. health care professional, consumer) to a company or regulatory authority that describes a suspected adverse experience. It does not include cases identified from information solicited by the applicant such as individual cases or findings derived from a study.

Study

Any organized data collection system (such as adverse experience information derived from a clinical trial, patient registry, including pregnancy registries). Reports from company-sponsored patient support programs should be handled as if they were study reports and not as spontaneous reports.

Text

A broad term for something that contains words to express something.

Universal Resource Locator (URL)

In addition to identifying a resource, URLs provide a means of locating the resource by describing its primary access mechanism (e.g., its network 'location').

Web Browser

A client program that initiates requests to a Web server and displays the information that the server returns.

Web Page

Any document that can be accessed by a URL on the World Wide Web.

Web Server

A software program that is capable of servicing Hypertext Transfer Protocol (HTTP) requests.

Web Site (or Website)

A related collection of files available on the Web that is managed by a single entity (an organization or an individual) and contains information in hypertext for its users. A Web site often includes hypertext links to other Web sites.

Web-based Application

An application that is downloaded from the Web each time it is run. The advantage is that the application can be run from any computer, and the software is routinely upgraded and maintained by the hosting organization rather than by each individual user.

World Wide Web (WWW)

A network of servers that contain programs and files. Many of the files contain hypertext links to other documents available through the network.

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