2 Configuring Argus Interchange

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

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Argus Interchange Mapping Utility

The Argus Interchange Mapping Utility enables you to store multiple profiles. This enables companies to transmit E2B reports to multiple agencies. The Argus Interchange Mapping Utility maintains an audit log that tracks every change made to the settings. You can also use this utility to view Trading Partner Configurations. This chapter includes discussions of the following:

Logging On and Off Interchange
Viewing Regulatory Authorities/Trading Partners
Configuring Argus Interchange Service
Adding a Database for Argus Interchange Service
Viewing the Audit Log
Comparing DTD Profiles
E2B Codes Translation
E2B Extensions

Logging On and Off Interchange

This section provides information about a logging in and out of Interchange.

Logging On to Interchange

To log on to Interchange:

Go to Start-->Programs-->Oracle-->ESM Mapping.
Enter the User Name, Password, and Database in the log on dialog.

Note:
The User Name and Password for the Argus Interchange Mapping Utility are created through User Configuration in Argus Console. This is done by selecting the ESM Admin role from the list of available roles in the User Role listbox.
Click Login.

Exiting from Interchange

To exit from the Argus Interchange Mapping Utility:

Select Administrator -> Exit to open a confirmation dialog.
Click Yes to exit Argus Interchange Mapping Utility.

Working with Profiles

The Argus Interchange Mapping Utility provides the following standard Message and Acknowledgement profiles:

ICH-ICSR V2.1 MESSAGE TEMPLATE
ICH-ICSR V2.1 MESSAGE TEMPLATE - EMA
ICH-ICSR V2.1 MESSAGE TEMPLATE - FDA
ICH-ICSR V3.0 MESSAGE TEMPLATE
ICH-ICSR V1.1 ACKNOWLEDGEMENT TEMPLATE
ICH-ICSR V1.1 ACKNOWLEDGEMENT TEMPLATE - EMA
ICH-ICSR V1.1 ACKNOWLEDGEMENT TEMPLATE - FDA
CBER EVAERS V1.0 MESSAGE TEMPLATE

Beginning Argus 8.0, the following profile template has been added:

ICH-ICSR E2B R3 MESSAGE TEMPLATE

This section provides information about working with profiles and includes discussions of the following:

Defining a Profile
Printing a Profile
Copying a Profile
Deleting a Profile

Defining a Profile

This section describes how to view or modify the rules of a DTD profile in Argus Interchange Mapping Utility. You can view profile details by selecting a Profile from the Argus Interchange Mapping Utility window.

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The following table lists and describes items that are common to each tab of the Argus Interchange Mapping Utility.

Using the Transmit Tab

The following is an illustration of the Transmit tab:

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To view details in the Transmit Tab:

Select a profile from the Profile drop-down list.
Click Transmit.

The following tables lists and describes the items on the Transmit tab:

Item	Description
Adverse Event Database Select Statement	Enables you to enter and view the SQL logic used to extract the value of the selected element of the DTD profile from AE database.
E2B Check checkbox	Indicates whether the selected profile is used in the E2B check functionality in Argus. The E2B check function is used to validate E2B reports based on the validation rules defined for the DTD profiles. Only the profiles that have the E2B check selected are used for validation.

Item

Description

Adverse Event Database Select Statement

Enables you to enter and view the SQL logic used to extract the value of the selected element of the DTD profile from AE database.

E2B Check checkbox

Indicates whether the selected profile is used in the E2B check functionality in Argus.

The E2B check function is used to validate E2B reports based on the validation rules defined for the DTD profiles.

Only the profiles that have the E2B check selected are used for validation.

Printing a Profile

This section describes how to setup your printer and print the profile.

Setting Up the Printer

You should set up your printer before printing a profile.

To set up your printer

Select Administrator -> Printer Setup to open the Printer Setup dialog box.
Select the default printer from this dialog box.

The following is an illustration of the Print dialog box.

Printing a Profile

Use the following procedure to print a profile.

Select Administrator -> Print Profile.
This prints the selected profile to your default printer.

The following is an illustration of a printed profile.

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Copying a Profile

Note:

The Copy Profile option can be used to create custom E2B profiles with customized Export / Import mapping logic for any E2B element. However, any new changes / fixes applied to factory E2B profiles are not automatically applied on the custom E2B profiles. Hence, the custom profile logic may get obsolete by any Argus Safety version upgrade which has changes / fixes applied to factory E2B profiles. In such a scenario, customers should re-create their custom E2B profile again, by copying the new factory E2B profile and applying their custom Export / Import mapping logic manually.

Use the following procedure to copy a profile.

In the Profile list, select the profile to copy.
Select Administrator -> Copy Profile, to open the Copy Profile dialog box.
Type the profile name in the To Profile field, click Save, and click OK.

Deleting a Profile

You can only delete profiles created or modified in the Interchange Mapping Utility interface. You cannot delete the pre-installed Argus Interchange profiles.

To delete a profile

Select the profile to delete from the Profile list.
Select Administrator -> Delete Profile.
Click Yes to confirm the deletion of the profile.

Viewing Regulatory Authorities/Trading Partners

Use the following procedure to view regulatory authorities/trading partners.

Select Administrator->Trading Partners to open the Agency List dialog box.
Double-click the required Regulatory Authority or Trading Partner to view its details.
The system opens the Trading Partner Configuration dialog box. You cannot modify the information in the dialog box.

Note:
To modify or create new Regulatory Authorities/Trading Partners, choose Reporting Destination in the Code List in Argus Console.

Configuring Argus Interchange Service

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

To configure Argus Interchange Service:

Select Administrator -> Setup INI File menu in the Interchange Mapping Utility to open the Service INI File Setup dialog box.
Use the items in the Service INI File Setup dialog to configure the Argus Interchange Service INI file.
Enter the data for each field as required.

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.

Adding a Database for Argus Interchange Service

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

To configure a database:

In the Setup INI File dialog box, double click Add New Process to open the Service DB Setup dialog.
Use the items in the Service DB Setup dialog to configure the ESM Service INI file.
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.

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.
Enterprise Short Name	Select the relevant enterprise short name, from the alphabetically-sorted list, containing all the enterprise short names. When an enterprise is selected, it loads the list of agencies for that enterprise in the Agency Name drop-down list.
Agency Name	Select the Agency from the drop-down list. This list contains all the agencies of the enterprise which had been selected in the Enterprise Short Name drop-down list. Note: If you change an agency name and also change the Incoming/Outgoing folders for the agency, the application prompts you to save the changes made.
Local Company	The system automatically populates this field when Agency is selected.
Incoming Folder	Enter the path to the folder where incoming files are stored.
Outgoing Folder	Enter the path to the folder where outgoing files are stored.
E2B Attachment Outgoing Folder	Enter the path to the folder where outgoing E2B attachments are processed.
Save Button	Click Save to set the Folder Paths configured for the Agency as Default. When selecting another agency to configure from the Drop Down, all the Paths will remain.
Delete Button	Click Delete to delete the entire configuration for the Agency selected only.

Viewing the Audit Log

The audit log stores changes made to the system from the application in the audit log. You can also view and filter individual changes.

To view the audit log:

Select Administrator -> Audit Log.
When the system opens the Audit Log dialog box, enter the appropriate data in each field and click Search.
When the system displays the search results, double-click a row to view detailed information about the changes made in the Audit Log Detail dialog box.
Select an item in the list at the bottom of the Audit Log Details dialog to view details of the old value and the new value of the selected item.

Audit Log Dialog Box Fields

The following table lists and describes the fields in the Audit Log dialog box.

Item	Description
From	Enter the search start date.
To	Enter the search end date.
Range	Select a pre-configured date range on for the search. Note: When the Argus Interchange Audit log is invoked, it shows the default range of the last 7 days.
User's List	Select a user from the list of users.
Print Log	Prints the current view.
Search	Performs the search.
Close	Closes the dialog.

Comparing DTD Profiles

You can compare two DTD profiles to find element-level differences. Select a source profile in the left pane and a target profile in right pane and run the Compare Profiles utility to generate the differences. The Compare Profiles utility also enables you to update the SQL statements (at the element level) of the Destination Profile elements with those of the Source Profile.

To compare DTD profiles:

On the Argus Interchange Mapping Utility menu bar, click Administrator -> Compare Profiles.
When the system opens the Compare Profiles dialog box, use the items in the Compare Profiles dialog to compare profiles.
Enter the data in the files as required.

Compare Profile Dialog Box Fields

The following table lists and describes the fields in the Compare Profile dialog box.

Item	Description
Source Profile drop-down	Is used for selecting a source profile from the available profiles configured in the system.
Destination Profile drop-down	Displays the profiles with the same DTD version and type (message/acknowledgement) as the ones in the Source profile. Note: The source profile is to be selected before selecting the destination profile. The destination profile is disabled if you have not selected the source profile.
Show Difference Only	Displays those nodes that contain different SQL statements between the source and destination profiles when this checkbox is checked.
Compare	Compares the differences between the source and destination profiles when this button is clicked. Note: The elements that are different in the Source and Destination profiles are displayed in a light gray background color.
Source Profile pane	Displays the source profile and its elements in a tree structure. When you click on any of the elements, the corresponding SQL statements are displayed on the source profile textbox, which is on the left-corner below the Source Profile pane.
Destination Profile pane	Displays the destination profile and its elements in a tree structure. When you click on any of the elements, the corresponding SQL statements will be displayed on the Destination profile textbox, which is on the right-corner below the Destination Profile pane.
Print	Prints all the SQL statements of the source and the destination profile with differences highlighted. Note: If there are no differences between the source and destination profiles, the following pop-up message is displayed: "No differences found' and no report shall be printed."
Update	Updates the individual SQL statements related to each element. Clicking the Update button also updates SQL statements in the destination profile. Note: The Update button is enabled when the nodes with different SQL statements are clicked.
Update All	Updates all the differences in SQL statements across all the elements between the source and destination profiles. Note: When a user clicks the Update All button, the following pop-up message is displayed: "Are you sure you want to update all the SQL statements in Destination Profile with Source Profile?" Clicking Yes updates all the SQL statements whereas clicking No does not update.
Close	Closes the Compare Profiles window.

Note:

The Update and Update All buttons are never enabled when the profile selected from the Destination Profile is of the type template.

E2B Codes Translation

E2B Codes Translation enables you to configure rules to translate the E2B codes and values in the incoming E2B reports, which come from different trading partners to preferred values in the AE system during case creation.

In the Interchange Mapping Utility, click Administrator -> E2B Translation Codes to open the E2B Code Translation screen.

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E2B Codes Translation Fields

The following table lists and describes the fields on the E2B Codes Translation screen.

Item	Description
Agency Name	Enables the user to select an agency name from the drop-down list box.
#	Displays the serial number.
DTD Element Name	Displays the DTD element name.
Input Value	Displays the type of input value
Output Value	Displays the type of output value.
Edit	Enables you to edit the information

Configuring E2B Codes Translation

Use the following procedure to configure E2B Codes Translation.

Select the Agency Name from the drop-down list box to displays the DTD Elements and their descriptions.
Click Edit to edit the DTD Element Name, Input Value, Output Value, and DTD Element Description.
Click Save to save your changes.

E2B Extensions

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 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 when the report is accepted or rejected by the user.

You can view the extended elements for the following:

ICSR 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 Selective Intake for Initial and E2B Difference Report for 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.

Argus Console

The Argus 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.

This section includes discussions of the following:

Configuring Regulatory Authorities
Configuring SMTP
Configuring Code List Items

Configuring 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:

On the Argus Console, Click Code Lists -> Argus.
When the system opens the Code List Maintenance screen, select Reporting Destination from the list.

Note:
If a report is already scheduled for a Reporting Destination, then clicking on the Delete button displays an error message that this item is already being used, and hence, cannot be deleted.

Refer to the Argus Safety Guide for information on using the first three tabs of the Reporting Destination.
Click the EDI tab, select the appropriate data for each item, and enter the data in the fields as required.

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/Control Name	Description
SGML/XML	Enables the user to select whether to send the report in SGML or XML format.
Agency Identifier	Enables the user to enter the routing ID configured in Cyclone for the sender community.
Identification Code	Enables the user to enter the agency Duns code, a unique identification code that identifies the trading partner. This field is disabled for the E2B (R3) profile.
Code Qualifier	Enables the user to enter the code qualifier here. The code qualifier is used to interpret the identification code. This field is disabled for the E2B (R3) profile.
Message Profile	Enables the user to select a message profile.
Mark as Auto Submit	Enables the user to mark the report for auto submission.
Auto Accept ICSR's	Click this checkbox to auto accept ICSR's. This checkbox is visible only when case numbering is set to Automatic.
ACK Profile	Enables the user to select the acknowledgement profile.
Primary Receive Agency	Enables the user to select the primary receiving agency.
Imported Cases are assigned to	Enables the user to select the country, where the imported cases need to be assigned. Note: This list comprises the configured Argus sites. The default value is the site of the importing user.
Initial Workflow State	Enables the user to configure the initial workflow state of the case. Note: This list comprises Argus workflow states, with the default value being blank. If you select blank as the workflow state, it is treated as a new case being booked-in.
XML Source Classification	The system enables the user to configure the XML Source Classification and the PDF Source Classifications used for classifications defined while the Source E2B File / PDF for Initial Intake or E2B Differences report is classified. When a case is accepted as an initial or follow-up case, the system attaches the source XML and the Initial Selection PDF to the case on the Additional Info tab.
Selection Source Classification	Enables the user to select the source classification from the drop-down.
Transmit E2B Attachments	Click this checkbox to transmit E2B attachments. If this checkbox is checked in the Reporting Destination Code List, case form attachments are sent to the specified reporting destination.
Attachment Classification	Enables the user to select the attachment classification.
Identification Code	Enables the user to enter the company Duns code, a unique identification code that identifies the trading partner.
Company Identifier	Enables the user to enter the company identifier
Code Qualifier	Enables the user to enter the code qualifier here. The code qualifier is used to interpret the identification code.
File Name	Enables the user to enter the file name
SGML Declaration File	Enables the user to enter the SGML Declaration File.
Maximum # of reports to include in the msg	Enables the user to enter the maximum number of reports that will be transmitted in one message.
Method	Enables the user to select a method here. This field contains E2B ESTRI Gateway and E2b Media values.
EDI Header Required	Enables the user to generate the EDI Header
XML Version	Enables the user to enter the XML Version.
URL of Message DTD	Enables the user to enter the path where the message DTD resides on the internet or enter full path if it is located on the disk.
Encoding	Enables the user to select the character set encoding used in XML
URL of ACK DTD	Enables the user to enter the path where the ACK DTD resides on the internet or enter the full path if it is located on the disk.

Configuring 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:

Open Argus Console.
When the system opens the Code List Maintenance screen, click System Configuration -> SMTP Configuration.
When the system opens the SMTP Configuration dialog box, enter the appropriate data in each field.

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.

Configuring Code List Items

Argus Safety Codelist values are associated to E2B Codes for the applicable factory data items. If you enter new codelist values, appropriate E2B codes must be entered for sending the newly added data in E2B reports.