Oracle® Argus Interchange

User's Guide

Release 8.1.2

E93463-02

October 2018

Oracle Argus Interchange User's Guide, Release 8.1.2

E93463-02

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Contents

Preface

- Audience

- Where to Find More Information

- Documentation Accessibility

- Revision History

1 About Argus Interchange

- 1.1 Argus Interchange Process Overview

- 1.2 ICSR

- 1.2.1 Minimum Requirement for Electronic Report Generation

2 Configure Argus Interchange

- 2.1 ESM Mapping Utility

- 2.1.1 Configure 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 Argus Console

- 2.2.1 Configure Regulatory Authorities

- 2.2.2 Configure Code List Items

3 Configure the Interchange Mapping Utility

- 3.1 Navigate to Interchange Mapping

- 3.2 Message and Acknowledgement Profiles

- 3.3 Manage Profiles

- 3.3.1 Define a Profile

- 3.3.1.1 Use the Transmit Tab

- 3.3.1.2 Use the Conformance Rules Tab

- 3.3.1.3 Use the Receive Tab

- 3.3.2 Use the Follow-up Receive Tab

- 3.3.3 Print a Profile

- 3.3.4 Copy a Profile

- 3.3.5 Delete a Profile

- 3.4 Compare Profiles

- 3.4.1 Compare Profile Dialog Box Fields

- 3.5 ICSR Codes Translation

- 3.5.1 Configure ICSR Codes Translation

- 3.5.2 ICSR Codes Translation Fields

- 3.6 View the Audit Log

- 3.6.1 Audit Log Dialog Box Fields

- 3.7 ICSR Extensions

4 Validate ICSR Reports

- 4.1 Why perform an ICSR check?

- 4.2 Report Generation Validations

- 4.3 Validation Rules

5 Transmit and Monitor Reports

- 5.1 Schedule Reports

- 5.1.1 New Expedited Report Dialog Fields

- 5.1.2 Nullification Reports

- 5.1.3 Follow-Up eMDR Reports

- 5.1.4 Follow-up eVAERS Reports

- 5.2 Generate Reports

- 5.3 Attachments in Reports

- 5.4 Transmit Reports

- 5.4.1 Transmit ICSR Reports

- 5.4.2 Transmit Bulk Reports by Form

- 5.4.3 Monitor ICSR Transmit Status

- 5.4.3.1 ICSR Transmit Status Fields

- 5.4.3.2 Message Acknowledgement Status Dialog Fields

- 5.4.4 Monitor ICSR Receive Status

- 5.4.4.1 ICSR Receive Status Dialog Fields

- 5.4.4.2 Message Acknowledgement Status Dialog Fields

- 5.4.4.3 Validation Check of Incoming Message

- 5.4.5 View Status

- 5.4.6 View Acknowledgement Information

6 Use the ICSR Viewer

- 6.1 Open the ICSR Viewer

- 6.2 Export an XML File

7 Import ICSR Reports

- 7.1 Incoming ICSR Reports

- 7.1.1 Import both E2B (R2) and E2B (R3) Messages

- 7.1.2 ICSR Import Framework

- 7.1.3 Interchange Accept Process

- 7.1.4 Search for Duplicate Cases

- 7.1.4.1 Duplicate Search Dialog Box Fields

- 7.1.5 Use the View Differences Report

- 7.1.5.1 Display Differences

- 7.1.6 View the E2B Report

- 7.1.7 Accept Single or Multiple E2B Reports

- 7.1.8 E2B Initial or Follow-up Intake

- 7.1.9 E2B Follow-up Acceptance for Closed or Locked Cases

- 7.2 Processed ICSR Reports

Preface

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

Audience

This guide is intended for the users and administrators of the Argus Interchange application.

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

Original document for the release.

2.0, October 2018

Updated field description for Agency Name in section ICSR Codes Translation Fields, to fix the following documentation related bug.

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

1 About Argus Interchange

Oracle Argus Interchange is an electronic submission and exchange module that enables the transmission of required ICH:E2B reporting functionality as well as the exchange of vital drug safety information with regulators and partners worldwide. Cases are reported instantly and accurately using standardized, worldwide reporting and transmission processes.

A color-coded graphical display provides peace of mind by delivering real-time insight into transmission status. Further, Argus Interchange is seamlessly integrated with Oracle Argus Safety, facilitating import, export, and transmission of cases. In addition, it supports immediate case triage upon electronic intake of data.

Argus Interchange provides the critical link to connect the pre-clinical and post-marketing safety information domains. This is the crucial component enabling pharma companies to communicate between their e-clinical and safety systems, delivering immediate return on investment gains. Argus Interchange will allow any standards-based systems (ICH:E2B to CDISC:ODM) to instantly exchange adverse events data. It thereby eliminates costly data entry redundancy and any possibility for introduction of errors.

Note:
The term E2B that is used in this document refers to E2B (R2), E2B (R3), eVAERS and E2B (R3)reports.

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 ICSR 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 Status

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 ICSR 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 ICSR Reports

Explains how to view the Processed ICSR Reports.

1.2 ICSR

ICSR is a a report that contains information describing a suspected adverse drug reaction related to the administration of one or more medicinal products to an individual patient.

E2B is the international standard for transmitting medicine adverse event reports specified by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

1.2.1 Minimum Requirement for Electronic Report Generation

The minimum requirements (mandatory) for generating an ICSR report are as follows:

1. One identifiable patient - any one of several data elements is considered sufficient to define an identifiable patient (such as initials, age, sex)

2. One identifiable reporter - any one of several data elements is considered sufficient to define an identifiable reporter (such as initials, address, qualifications)

3. One adverse event/reaction (or outcome), and

4. One suspect or interacting drug

Reporting Destination can be configured with a message profile for E2B(R2), E2B(R3), eMDR or eVAERS report form.

E2B (R2) report contains the following information:

A: Administrative and Identification Information

A.1 - Identification of the case safety report

A.2 - Primary source(s) of information

A.3 - Information on sender and receiver of case safety report

B: Information on the Case:

B.1 - Patient characteristics

B.2 - Reaction(s)/event(s)

B.3 - Results of tests and procedures relevant to the investigation of the patient

B.4 - Drug(s) information

B.5 - Narrative case summary and further information

E2B (R3) and eVAERS reports are built using HL7 version 3 (V3) messaging standards with the following sections:

Section A:

C.1 - Identification of the Case Safety Report

C.2 - Primary Source(s) of Information

C.3 - Information on Sender of Case Safety Report

C.4 - Literature Reference(s)

C.5 - Study Identification

Section B

D - Patient Characteristics

E - Reaction(s)/Event(s)

F - Results of Tests and Procedures Relevant to the Investigation of the Patient

G - Drug(s) Information, and

H - Narrative Case Summary and Further Information

eMDR reports are built using HL7 version 3 (V3) messaging standards with the following sections:

A - Patient Information

B - Adverse Event or Product Problem

C - Suspect Product Information

D - Suspect medical device

E - Initial Reporter

F - For Use by User Facility/Importer (Devices Only)

G - All manufacturers

H - Device manufacturers only

The following are the key features of reports in HL7 format:

1. Structure and Cardinality - Messages are built using Health Level 7 Version 3 (HL7 V3) messaging standard.

2. International Standard Code Sets - International Standard Code Sets are used in HL7 messages: ISO 5218, ISO 639-2, NCI and UCUM.

3. Null flavors - ICH ICSR uses the codes from the HL7 Messaging Standard to categorize exceptions. Null flavor such as NI, NA, UNK enables transmission of an empty element and provides an explanation for the reason for the lack of data using codes. Confidential information such as Patient or Reporter's name and address can be masked by the sender due to security, privacy or other reasons by using MSK Null flavor.

4. Attachments can be presented in-line within the ICSR message itself. In-line data is transmitted as part of the encapsulated data value in the ICSR message.

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 ESM Mapping Utility

Argus Interchange mapping utility helps to configure the Argus Interchange Service.

2.1.1 Configure 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 2012R2 server, navigate to Apps and click 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 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

2.2.1 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 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 Administrator's Guide, Configuring Reporting Destination section for information on using Reporting Destination.

2.2.2 Configure 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.

3 Configure the Interchange Mapping Utility

This chapter provides information on configuring and mapping the web-based Argus Interchange.

3.1 Navigate to Interchange Mapping

To navigate to the Interchange Mapping menu:

1. Open Argus Console.

2. Go to System Configuration ->Interchange Mapping.

3.2 Message and Acknowledgement Profiles

Argus Interchange Mapping 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 V3.0 MESSAGE TEMPLATE - EMA

- ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE – EMA

- 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

- CDRH eMDR V1.0 MESSAGE TEMPLATE

Import profiles for EMA & PMDA E2B (R3)

Two new Import profiles for EMA & PMDA E2B (R3) are now available.

- A new EMA (R3) profile with OOTH Export and Import mappings with all standard features such as Copy, Edit, Print and Audit.

- A new EMA (R3) acknowledgement with default mappings and with all standard features such as Copy, Edit, Print and Audit.

All conformance rules are added to the OOTB EMA (R3) profile.

Low level Ack generation is supported for EMA (R3) import using physical media.

3.3 Manage Profiles

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

3.3.1 Define a Profile

This section describes viewing or modifying the rules of a profile in the Interchange Mapping. You can view profile details by selecting a Profile from the Interchange Mapping screen.

On selecting a Profile from the drop-down, the system displays the following information:

- The tree view structure of ICSR elements

- The Transmit and Receive tabs

The following notes are displayed at the bottom of the screen:

- When a profile provided as part of the factory data is selected, * Profile Type is TEMPLATE. All Fields are Read-only.

- When a custom profile is selected, * Profile Type is User DEFINED. Fields with white background are editable.

3.3.1.1 Use the Transmit Tab

Use the following procedure to view details on the Transmit Tab:

1. Select a profile from the Profile drop-down list.

2. Click Transmit.

The following table lists and describes fields 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 profile from the AE database.

ICSR check checkbox

Indicates whether the selected profile is used in the ICSR check functionality in Argus.
The ICSR check function validates E2B reports based on the validation rules defined for the profiles.

Only profiles that have the ICSR checkbox selected are used for validation.

Blind in PMDA AE Paper Report

Select this check box if the selected profile must be blind in the PMDA AE Paper Report.
This check box is available only for PMDA E2B R2 Profiles for Japanese user and if the Japanese version is enabled.

Configured Transmit Logic

This drop-down lists the descriptive names (alphabetical order) for all the configured Transmit Mapping logic for the particular element across all the HL7 based ICSR profiles. The first value is blank and the last value is (Add New). This drop-down value is available for editing for all custom profiles and is read-only for OOTB Template profile.

3.3.1.2 Use the Conformance Rules Tab

The Conformance Rules tab is available to the users for the E2B (R3) and PMDA E2B (R3) profiles. The Japanese DTD tab is not available to PMDA E2B (R3).

The tab allows user to configure the following parameters against each ICSR Element node for which data is transmitted (as it is applicable only for E2B export logic). It is available only for the ICSR Element Nodes (except for the Message & Batch Header tags - N) for which data is transmitted and is not available for parent element, as the attributes specific to validations are applicable only at root element level.

This configuration remains un-editable (read only) for all out-of-the-box E2B (R3) based ICSR template profiles (EMA, PMDA) but is allowed to be edited for custom/copied profiles. (The configuration data for out-of-the-box mapping profiles is available with the mapping of that profile).

The Conformance Rules tab data is also copied to the new profile when user copies any existing ICSR profile.

Editing Conformance rules is allowed only for custom profiles.

The following is the Conformance Tab for PMDA profile:

To configure the validations rule against the ICSR element, following fields have been made available to user under the Conformance Rules tab:

Field

Type

Description

Field Name / Field Name (J)

Textbox
Length:255 AN

Field Name/Label of the Case form or Console UI field to which the element's mapping logic corresponds to is specified in this field.
EMA: English

PMDA: Japanese

For PMDA E2B (R3): Refer Mapping xls > Mapping(Sheet) >  UI Field Name(J)

Field Location

Textbox
Length:255 AN

UI Fields Location/path of the Case form or Console UI field to which the element's mapping logic corresponds to is specified in this field.
EMA: English

PMDA: Japanese

For PMDA E2B (R3): Refer Mapping xls > Mapping (Sheet) > UI Field Name(J)

Data Type

Drop-down list

This drop-down list has the following options in the below specified order:
Blank (Default)

Country

Date/Time

E2B Code

MedDRA Term/Code

MedDRA Version

Text

For PMDA E2B (R3): Refer Mapping xls > Mapping(Sheet) > PMDA Data Type DTD (R3)

Data Length

Textbox
Length: 9 chars

This text box allows user to enter only Numeric Values
For PMDA E2B (R3): Refer Mapping xls > Mapping(Sheet) >  PMDA Length DTD (R3)

Mandatory Along with

Drop-down list

This drop-down list contains the DTD_ELEMENT names that are present under the same parent of the selected element (except the selected element itself), with blank as the first and the default option
Format: DTD_ELEMENT(DATA_ELEMENT)

Display Order: Same as they are listed in the Element navigation tree on the left

For PMDA E2B (R3): Refer Mapping xls > Mapping(Sheet) > Mandatory Along with

Allowed Value Check Required

Checkbox

This checkbox is left unchecked by default
For PMDA E2B (R3): Refer Mapping xls > Mapping(Sheet) >  Allowed Values

Allowed Values

Button

Clicking this button opens up Allowed value configuration Dialog for configuring the allowed values for the selected elements against that profile
This button is enabled only if Allowed Value Check Required checkbox is checked

For PMDA E2B (R3): Refer Mapping xls > Mapping (Sheet) >  Allowed Values

Primary Validation Category

Drop-down list

This drop-down list is available for EMA profiles only.
The following option is listed in the drop-down list in the below specified order:

Blank (Default)

Mandatory

Conditional Mandatory

Do not enter

Other Fatal Validation

Optional

Additional Validations

Button

On clicking this button Additional Validation Configuration Dialog opens up, this Dialog enables users to configure the SQL based validations for the element.
This button is available for EMA.

PMDA Specific

Reporting Category

Label

All Reporting Category (R3) Codes (AA, AB, AC, AD, AE, AF, AG, DA, DB, DC, DD, DE, DF, DG, BC, BD) as configured in the Reporting_category (flex code list) are listed here, along with Nullification.

Reporting Category Description

Label

Description of the corresponding Reporting Category is listed here.

Primary Validation Category

Drop-down list

This drop-down list is available for PMDA profile only.
The following option is listed in the drop-down list in the below specified order:

Blank (Default)

Mandatory

Mandatory for Completion Report

Conditional Mandatory for Completion Report

Conditional Mandatory

Do not Enter

Other Fatal Validation

Optional

For PMDA E2B (R3): Refer Mapping xls > Mapping (Sheet) >  Reporting Category wise Conformance

Additional Validations

Button

On clicking this button Additional Validation Configuration, the Dialog opens. This Dialog enables users to configure the SQL based validations for the element.
Available button available against each Reporting Category.

Save

Button

On clicking the Save button, the changes are committed to Data base and audit logged.
This committing of data includes any changes done in the Allowed Value Configuration and Additional Validation Configuration Dialogs as well.

On clicking the Save button, the application logic validates that there exists a Primary category for the ICSR Element

- In case of Non-PMDA profile: Element Level

- In case of PMDA: Reporting category level

If there exists a row with primary category as blank, the application displays an error message: Please select a Primary Validation category for the element Title: ICSR Validation with OK Button.

Print

Button

On clicking the print button, the application prints all the Conformance rule tab data.

The Allowed Values Configuration Dialog

On clicking Allowed Values, the Allowed Values Configuration Dialog (modal Dialog) opens. The Allowed Values Configuration Dialog lets users View, Add, Update, Delete and Associate/De-associate the Codes and Description attribute of the Allowed values for the particular ICSR element for that profile.

Description for fields/buttons on the Allowed Values Configuration Dialog:

Table 3-1 Allowed Values Configuration Dialog fields

Code textbox

This is a textbox where user enters the Code value that is being transmitted in the ICSR report. For example, E2B R3 Codes, ISO code and so on.

Description textbox

This is a textbox where user enters the description against the Code that is being transmitted in the ICSR report.

Description (J) textbox

This is a textbox where user enters the Japanese description against the Code that is being transmitted in the ICSR report. This is visible only to J user (when J module is enabled) and only for PMDA Profile

Edit button

On clicking the edit button, the Code and Description textboxes become enabled for user to edit

The Additional Validation Configuration Dialog

Clicking Additional Validations displays the Additional Validation Configuration Dialog which lets the user View, Add, Update, Delete, Associate/De-associate, categorize and mark a validation to be Primary for the ICSR element of that profile.

If user marks any validation as Primary, the Associated drop-down list is disabled by default.

On unchecking the Primary Validation checkbox, the Primary validation checkbox for all other validations and the Associate and Validation Category drop-down lists for this particular validation are enabled.

For EMA profiles, the Additional Validation can be configured at the element level, whereas for the PMDA profile the validation can be configured individually against each reporting category for that element.

The OOTB validations are only allowed to be Associate, Disassociate, categorized or marked as primary for the element, and the Edit button always remains disabled for all such OOTB validations.

Description for fields/buttons on the Additional Values Configuration Dialog:

Table 3-2 Additional Values Configuration Dialog fields

Message Text area

In this text area, the user specifies the message that is printed in the validation report in case of a failure validation.

Message (J) Text area

In this text area, the user specifies the Japanese message that is printed in the validation report in case of a failure validation. This is visible only to J user (when J module is enabled) and only for PMDA Profile.

Validation SQL Text area

In this text area, the user specifies the SQL condition for the validation that is executed in order to run this particular validation.

Edit button

On clicking the edit button, the Message and Validation SQL text areas becomes enabled for user to edit.

Associate Drop-down list

Lets the user associate or de-associate the allowed value for an element for the profile and has the following set of values:

(R3) profiles that supports both Export & Import, that is, EMA (R3)

a. Blank (Validation not associated with this profile)

b. Transmit (Validation only applicable during export)

c. Receive (Validation only applicable during Import)

d. Transmit & Receive (Validation applicable for both Export & Import)

(R3) profiles that support Export but do not support the Import

a. Blank (Validation not associated with this profile)

b. Transmit (Validation only applicable during export)

Validation Category

User specifies the category of validation by selecting an option from this drop-down list.

Primary Validation checkbox

User marks a validation as primary validation against an element for the profile by checking this checkbox.

Add button

On clicking the Add button, a new row is added to the grid, with Message, Description text areas, Associate drop-down list and Validation Type drop-down list (blank) enabled by default.

Delete button

Deleted button is disabled by default, and is enabled only if user selects a user created custom validations row in the grid.

3.3.1.3 Use the Receive Tab

Use the following procedure to view details on the Receive Tab:

1. Select a profile from the Profile drop-down list.

2. Click Receive.

The following table lists and describes the fields on the Receive tab:

Item

Description

Import Mapping Logic: PL/SQL Code

Enables you to enter and view the PL/SQL code to be processed for the selected element of the profile during the import.

Enable Post-Save checkbox

Enabled for Template and Custom profiles and is a profile level switch. When this checkbox is marked, then post-save routines are executed while importing an ICSR message.

Extended ICSR

Enabled only for Custom profiles and is a profile level switch.
When this checkbox is marked, the profile is considered as an Extended ICSR Profile (ICSR+ Profile).

Current Element is part of Primary Key

When this checkbox is marked, this field is treated as part of the Primary key. Values in Primary keys are used for matching data in an existing case while importing Follow-up reports.
Based on the results, either a new record is created or an existing record is updated.

Select AE column as a part of Primary Key

Displays the Argus Case Form Database column name to which the current primary key E2B element is mapped.
This relationship compares the E2B element from the incoming follow-up report to the related Case Form database column name value in the target case to identify matching records in repeater sections.

Always Import for Initial/Follow-up reports

Governs the default UI behavior of the Import checkbox that appears against each element in the E2B Difference Report screen. If this checkbox is checked for an element, the corresponding checkbox on the E2B Difference Report screen also appears as checked and disabled. By enforcing the behavior of always importing that element, the user cannot uncheck the checkbox on the E2B difference screen.

Configured Receive Logic

This drop-down lists the descriptive names (alphabetical order) for all the configured Import Mapping logic for the particular element across all the HL7 based ICSR profiles. The first value is blank and the last value is (Add New). This drop-down value is available for editing for all custom profiles and is read-only for OOTB Template profile.

3.3.2 Use the Follow-up Receive Tab

A new tab Follow-up Receive, for configuring certain configuration attributes for the ICSR profile that are specific for the Follow-up imports of the ICSR file has been introduced. This tab is available be available for the (R3) based ICSR profiles that support the import (currently applicable for EMA and PMDA (R3)).

To configure the validations rule against the ICSR element, following fields have been made available to user under the Follow-up Receive tab:

Field

Type

Description

ICSR Follow-up case identification logic

Text Area

Profile level logic to identify the Follow-up case against the incoming ICSR.
OOTB default logic: Current Argus embedded logic

Custom comparison logic

Text Area
Default : Blank

Profile level option to specify the logic to customize the OOTB PK driven Difference report data such that user can define a PL/SQL block with this section to control the Difference report data that will be further used during the case acceptance.
The order of execution for the Custom logic is that, first all the embedded OOTB system logic to build the comparison data are executed with application of Default deletes, and then once the embedded logic for Difference report execution is completed the configured custom comparison logic is invoked and the result of that custom logic is reflected on the difference report UI and further will be consumed during case data acceptance.

The Configured custom logic is executed under the same DB user level access right as application does for import mapping SQL logic. Validate that under the same access right user is able to update, insert and delete the data of the Difference report table.

Any changes to the custom logic are audit logged and are supported in the copy profile and print as well.

Application provides all the possible Bind variable that this custom logic would require in order to define the business specific logic.

PK Element configuration

Download (Button)

This button facilitates the user to configure the PK's for identifying the repeater records in the ICSR file, so that those can be used while building the Difference report such that, if for a repeater record the configured PK elements are same in the incoming ICSR and the ICSR from the Case data then that record shall be treated as the same record.
On clicking of the Download button application will export a CSV file with all the PK's for that profile as per the attached sample.

PK Element configuration

Upload (Button)

On clicking the upload button the standard Argus upload dialogue appears
with fowling title and label:

Title: ICSR Mapping Utility

Label: ICSR PK Element Configuration

Allowed File Types: CSV

As soon as user uploads the CSV file with the application executes a validation over the uploaded file to in order to validate that the uploaded CSV file is as per the application expectations.

- Profile: column lists only the name of the profile for which file is getting uploaded. In case of any mismatch an error is pushed into Val_error column (<Profile Name> is different than the current profile).

- PARENT_ELEMENT: The data in this column is validated to list down only those elements which have child elements to them in the current profile. In case of any incorrect entry an error is pushed into Val_error column (<Parent Element> is not a valid Parent element as per the current profile).

- DTD_ELEMENT: The data in this column is validated to list down only those elements are true child elements i.e. they are the exact root node of the xml. In case of any incorrect entry an error is pushed into Val_error column (<DTD Element> is not a valid Child element as per the current profile).

- DTD_ELEMENT: The data in this column is validated that the elements belongs to the Parent element as per the current profile. i.e. DRUGCHARACTERIZATION - Parent element is "DRUG" as per the EMA R3 OOTB Profile whereas in the uploaded CSV the parent for the same is mentioned as DRUGINDICATIONR3 then the error is pushed to the VAL_Error column (<DTD Element> doesn't belong to <Parent Element> as per the current profile).

- DEFAULT_DELETE: The data in this column is validated to see if it contains any value other than "Y" or "N". Where "Y" denotes that the repeater element will be marked for Deletion by default in case of no match with the incoming file. And "N" denotes that that the repeater block will not be marked for deletion by default. In case of any other value in the columns the error is pushed to the VAL_Error column (Incorrect value. Value should be either "Y" or "N").

- DEFAULT_DELETE: The data in this column is validated to see the same value exist for all the rows for a particular PARENT_ELEMENT i.e. for all the rows for a particular parent element the value for DEFAULT_DELETE should be same. In case of validation failure the error is pushed to the VAL_Error column (All the values corresponding to <PARENT_ELEMENT> should be same).

- None of the four columns "PROFILE", "PARENT_ELEMENT", "DTD_ELEMENT" & "DEFAULT_DELETE" are blank for either of the row. In cases any of them is blank the error is pushed to the VAL_ERROR column(<Column Name(comma separated)> cannot be blank).

- As soon as user upload the CSV file all the above validation is executed and in case there are any errors the file with the error listed in VAL_ERROR column is pushed to user from the browser (all these operations shall be performed within the upload user action). Also, if there are any validation errors the uploaded file data is not reflected into the DB configurations i.e. only a file without any validation errors can be committed to DB.

- All the changes to the PK's are audit logged.
The VAL_ERROR column is only present in CSV file only when there are any errors to the uploading file. It is not be present in the normal downloaded or uploaded file.

3.3.3 Print a Profile

Use the following procedure to print a profile.

1. Select the profile to print from the Profile list.

2. Click Print. This prints a PDF of the selected profile.

3.3.4 Copy a Profile

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

Use the following procedure to copy a profile.

1. Select the profile to copy from the Profile list.

2. Click Copy Profile, to open the Copy Profile dialog box.

3. Type the profile name in the To Profile field, and click Save.

3.3.5 Delete a Profile

You can only delete profiles created or modified in the Interchange Mapping interface. You cannot delete Template profiles.

Use the following procedure to delete a profile.

1. Select a custom profile to delete from the Profile list. The system enables the Delete button.

2. Click Delete.

3. Click Yes to confirm.

3.4 Compare Profiles

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

To compare profiles:

1. On the Argus Interchange Mapping menu, click Compare Profiles.

2. When the system opens the Compare Profiles dialog box, use the items in the Compare Profiles dialog to compare profiles.

3. Enter the data in the files.

3.4.1 Compare Profile Dialog Box Fields

The following table lists and describes the fields on 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 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 are 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 appears: "No differences found and no report is 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 appears: "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.

3.5 ICSR Codes Translation

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

Go to Argus Console -> System Configuration -> Interchange Mapping -> ICSR Translation Codes to open the ICSR Code Translation screen.

Note:
Argus Console -> Interchange Mapping -> ICSR Code Translation has been enhanced to list all (R3) elements in addition to the existing elements in the DTD Element Name drop-down list as specified in Codelist Translation column of the Import Mapping xls. The values in this drop-down list are filtered based on what is selected in the newly added ICSR Type drop-down list, that is, if (R2) is selected, then all (R2) elements are listed and if (R3) is selected, all (R3) elements are listed.

3.5.1 Configure ICSR Codes Translation

Use the following procedure to configure ICSR Codes Translation.

1. Select the Agency Name from the drop-down list box to display the Elements and their descriptions.

2. Click on the respective field to edit the Element Name, Input Value, Output Value, and Element Description.

3. Click Save to save your changes.

3.5.2 ICSR Codes Translation Fields

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

Item

Description

Agency Name

Enables the user to select an agency name from the drop-down list box. This drop-down lists the agencies configured with the (R3) profile (that supports the import of ICSRs) under the EDI tab (applicable for PMDA (R3) and EMA (R3) along with the (R2) agencies.

#

Displays the serial number.

ICSR Type

Enables the user to configure the translation code at the ICSR message type level. It lists two values (R2) (default) and (R3), and is enabled by default when the user creates any new entry to translation configuration.

Element Name

Displays the element name.

Input Value

Displays the type of input value.

Output Value

Displays the type of output value.

3.6 View the Audit Log

The Audit Log stores changes made to the system from the application. You can also view and filter individual changes.

Use the following procedure to view the Audit Log:

1. On the Argus Interchange Mapping menu, click View Audit Log.

2. When the system opens the Audit Log dialog box, enter the appropriate data in each field and click Search.

Note:
For more information on Audit Log Dialog box fields, see Audit Log Dialog Box Fields.

3. 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.

4. Select an item in the list at the bottom of the Audit Log Details dialog to view details of the old and new values of the selected item.

3.6.1 Audit Log Dialog Box Fields

The following table lists and describes the fields on 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 for the search.
Note: When the Argus Interchange Audit log is invoked, it shows the default range of the last 7 days.

User Name

Select a user from the list of users.

Print

Prints the current view.

Search

Performs the search.

3.7 ICSR Extensions

For more details, from the Argus Safety OHC">>Argus Safety OHC page, download the Technical Reference Manuals, and refer to the >Oracle Argus Interchange ICSR Extensibility Guide.

4 Validate ICSR Reports

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

4.1 Why perform an ICSR check?

During case data entry and prior to E2B file generation, the user may want to verify that sufficient data and the quality of data collected will generate a valid E2B file.

To do so, a Data Validation check is required for E2B profiles and to provide a listing of data elements that do not satisfy the criteria required to generate an E2B report.

On performing an ICSR check, the system performs a validation and lists the following types of validation errors for the data elements that are failing the validations in the ICSR Report data check errors and warnings:

E2B (R2), eVAERS, and eMDR:

1. Mandatory

2. Mandatory Optional

3. Together DTD Element Validation

4. Other Validation

5. Date Validation

6. E2B Generation Validation (only E2B(R2) reports)

7. Encoding Validation

8. Length check Validation

E2B (R3):

1. Mandatory

2. Conditional Mandatory

3. Other Validations

4. Together DTD Validation

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.

ICSR check can be used to validate E2B (R2), eVAERS and eMDR reports, provided the ICSR check flag is marked in the Interchange Mapping Utility.

ICSR check can be used to validate EMA E2B (R3) and PMDA E2B (R3) profiles provided the following conditions are met:

- ICSR check flag is marked in the Interchange Mapping Utility

- Profile is configured with atleast one of the reporting destinations

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 following are not covered by ICSR check:

- Attachment size validations are not supported as part of the ICSR check for any of the E2B (R3), eMDR, and eVAERS Profiles.

- The ICSR check does not validate data elements pertaining to the Batch and Message headers of the ICSR.

- Validation are not be provided for elements that are mandatorily captured in Argus Safety.

- Validations related to follow-up and Nullification reports are not displayed in the ICSR check report.

To perform an ICSR check, the system requires some reference data based on which validations can be performed. The system uses the following (existing) logic:

Agency

Considers the first available Agency that was configured with the Profile in Reporting Destination.

Product License

Considers the License used in the first available Product in the Case Form.

Reporting Category (for PMDA (R3))

Uses the Reporting Category data for the first available Product in the Case Form.

4.2 Report Generation Validations

The system performs the following validations at the time of report generations and displays validation error if there are failures:

1. Missing Mandatory Elements

2. Missing Mandatory Optional Elements

3. Length Validation for character data

4. M2 Code validation

5. Report File Size validation (for HL7 Reports only)

6. File type of attachments that qualify to be included

The system displays an error message in the following scenarios:

1. While generating draft E2B or eVAERS or eMDR report using Draft tool button, if the default Reporting Destination is not specified for E2B or eVAERS or eMDR in Common Profile Switches.

2. While generating draft/final E2B or eVAERS or eMDR report for the Reporting Destination which is not configured with valid Message Profile as E2B or eVAERS or eMDR respectively.

3. While generating E2B(R3) or eVAERS or eMDR report, if the size of inline attachments or overall size of xml file exceeds the maximum file size limit specified in the Reporting Destination configuration.

4. While validating the file type of the attachments that qualify to be included in the E2B(R3) report and displays a validation message to indicate the file type provided for the attachment does not confirm with the allowed file types for the report.

4.3 Validation Rules

Validation Rules for all profiles can be viewed from Argus Console > System Configuration > Interchange Mapping > Manage Profile.

E2B Generation validation rules are executed on the generated ICSR report data.

The validation rules that are applicable to individual element is governed by configuration in the Conformance Rules tab for that element for the respective profile.

Validation Rule the elements is categorized amongst the following categories:

- Basic Data Validation: This category covers all the applicable validation based on the Length of the field.
Length - This validation check validates if the data type length of output is within with the configured Data length or not. If the data length is exceeding the configured length then validation error is listed in the validation report.

- Allowed Values Data Check: The element for which the Allowed Value Check Required checkbox is checked is validated against the allowed values codes associated with them using Allowed Values Configuration Dialog for the respective profile.

- Mandatory Along with (Together): Elements for which the Mandatory along with element is specified, validation rule validates for such elements in the generated ICSR the element itself and the configured Dependent element co-exist or none of them exists in the report.

- Validation Category Based: The element is validated as per the value configured for that element in the Validation Category drop-down list in the Conformance rule tab.
The elements for which there exists a SQL based validation for which Primary Validation checkbox is checked in the Additional Validation Configuration Dialog, the framework based validation is not executed for them; rather the configured SQL based validations is executed for them.

These validations are categorized in two sub categories, one for the ICSR reports for EMA the profile, and the other ICSR Report for PMDA profile

- EMA

The validation for the PMDA report is fired at each reporting category level:

Mandatory: The element which is configured as Mandatory should be present in the ICSR Report; if it is not present in the report output then application displays the validation failure in the validation report.

Conditional Mandatory: The element which is marked as Conditional Mandatory is present based on certain condition, hence it is expected that user will configure a Validation for it in the Additional Validation Dialog. There is no framework based validation for the elements configured with this validation type in Conformance rule tab.

Optional: The element which is marked as optional may or may not be present in the report, but still there could be a possibility that there might exist a validation under the Additional Validation Dialog and if any of the configured validation is failed it will be listed in the validation report.

Other Fatal: There is no framework based validation for the elements configured as other fatal validation type in Conformance rule tab.

- PMDA E2B
Mandatory: The element which is configured as Mandatory should be present in the ICSR Report; if it is not present in the report output then application displays the validation failure in the validation report.

Mandatory for Completion: The element which is marked as Mandatory for completion should be present in the ICSR Report if J2.7.1 (MHLWADMICSRCOMPLETECLASS) = completed for that report; if it is not present then application displays the validation failure in the validation report.

Conditional Mandatory and Conditional Mandatory for Completion: The element which is marked as Conditional Mandatory or Conditional Mandatory for Completion is present in the report based on certain condition, hence it is expected that user will configure a Validation for it in the Additional Validation Dialog. There is no framework based validation for the elements configured with these validation types in Conformance rule tab.

Do not Enter: The element which is marked as Do not enter are not present in the report, and if they are present than application lists the validation failure in the validation report (Argus report generation logic removes the elements that are marked as Do not enter at the time on generation itself).

Optional: The element which is marked as optional may or may not be present in the report, but still there could be a possibility that there might exist a validation under the Additional Validation Dialog and if any of the configured validation fails, it is listed in the validation report.

Other Fatal: There is no framework based validation for the elements configured as other fatal validation type in Conformance rule tab.

- Additional Validations: The Additional SQL based validations associated with elements in the respective ICSR profile (element level for E2B other than PMDA and Reporting category level for PMDA E2B), the validation is fire based on the SQL logic specified under the Validation SQL.

5 Transmit and Monitor 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.

5.1 Schedule Reports

Argus Safety enables you to schedule your E2B, eMDR and eVAERS reports. In addition, it allows you to generate these 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 such as &amp; for (&), &lt; for (<), &gt; for (>), &apos; for (') and &quot; for (") as per XML specifications.

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 from the bottom of the screen.

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

5.1.1 New Expedited Report Dialog Fields

The Schedule New Expedited Report window has a Report Information 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.
Note: This field is displayed when an E2B or eVAERS report is selected as the Report Form. If the Report Form is selected as eVAERS then the Message type is set to ichicsr and is disabled.

Aware Date

Select the Aware date for which the report is required to be scheduled.
Amendment reports can be scheduled by selecting the Aware date which is appended with text (A).

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.

Protect confidentiality of Reporter and Patient

Select this checkbox if you do not wish to disclose the identity of the reporter and the patient in the report.

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.

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.

5.1.2 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/ N.1.2

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 / N.1.5

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/C.1.2

System enters the message date.

A.1.13/C.1.11.1

System enters 1=Yes on the Nullification report.

A.1.13.1/C.1.11.2

System enters the reason for the Nullification report.

J.2

System increments this value every time it transmits the report.

J.4b

System enters the PMDA Acknowledgement Number.

J.5

System increments this value every time it submits the report.

J.6

System will enter 1. 1 means that it is a completion report.

J.7

System will remove the value of this tag, if it was present in the previous 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.

- Nullification reports are not scheduled for eMDR.

5.1.3 Follow-Up eMDR Reports

If an eMDR report is manually scheduled or automatically scheduled for the same reporting Destination, system either schedules Initial or Follow-up report based on the same logic (product license ID and status of previously scheduled report) that is currently existing for Device reports.

If the case was previously submitted to a Reporting Destination as MedWatch Device report and if the same reporting destination is configured for sending eMDR report:

1. System schedules the next eMDR as a follow-up report and displays the follow-up numbering in the Case Form ' Regulatory Reports ' Seq field by considering the previously reported MedWatch device report.

2. System uses the same report number (F.2 or G.9) that was used in MedWatch Device report in eMDR for the data element ufimporterrepnumber(F2) or mfrreportnumber (G9).

3. Follow-up number that is populated in (F7 uffollowupnumber or G7 gfollowupnumber) shall be incremented from (F7 or G7) of the previously submitted MedWatch Device report by considering the internal common profile switch Allow generation of Report.

Example : If F/p 1 report was submitted as 0000555-2014-00011 to CDRH in MedWatch format and the next follow-up report in eMDR format, then Mfr Report # shall be populated as 0000555-2014-00011 and F/p number as 2.

If the previous report was sent by eMDR and the subsequent report is being sent as MedWatch Device to the same destination, the system shall maintain the report numbering (F2 or G9) same as of previously submitted eMDR.

1. System schedules a follow-up report by populating Follow-up' in the Case Form Regulatory Reports' Seq column.

2. System uses the same report number (F2 or G9) from the previously submitted eMDR report in the F2 or G9 of MedWatch Device report.

3. Follow-up number that is populated in (F7 or G7) is incremented from (F7 uffollowupnumber or G7 gfollowupnumber) of the previously submitted eMDR report by considering the internal common profile switch Allow generation of Report.

4. The MedWatch Device scheduled after the eMDR report does not respect the Common Profile Switch "Data to print on follow up MedWatch Device form "and system displays a warning message during manual scheduling of report as Delta data will not be printed MedWatch Device form for this Device license as it was previously submitted as an eMDR. In case automatic scheduling, this warning message is logged against the report without impacting report scheduling or generation.

Example : If F/p 1 report was submitted as 0000555-2014-00011 to CDRH in eMDR format and the next follow-up report in eMDR report fails due to some reason and company decides to send them in MedWatch device format, then MedWatch report shall print Mfr Report # as 0000555-2014-00011 and F/p number as 2

System includes complete data in follow-up eMDR as the other E2B (R3) reports.

Note:
Common Profile Switch Data to print on follow up MedWatch Device form does not have any impact on eMDR follow-ups.

Downgrade report is scheduled automatically if the F/UP version does not satisfy the Regulatory Reporting Rules defined for eMDR for a case that was previously submitted in eMDR.

Follow-up eMDR is scheduled automatically if the Significant F/UP version is marked as Amendment for a case that was previously submitted in eMDR (existing functionality for non E2B (R3) reports).

Nullification reports are not scheduled for eMDR.

5.1.4 Follow-up eVAERS Reports

If an eVAERS report is manually scheduled or automatically scheduled for the same reporting Destination, system either schedules Initial or Follow-up report based on the same logic (product license type and status of previously scheduled report) that is currently existing for E2B reports.

If the case was previously submitted to a Reporting Destination in VAERS PDF format and if the same reporting destination is configured for sending eVAERS report:

1. System schedules the next eVAERS as a follow-up report and displays the follow-up numbering in the Case Form ' Regulatory Reports ' Seq field by considering the previously reported VAERS.

2. If any Follow-up reports are scheduled to the same destination at a later point of time, system schedules a follow-up report by populating'Follow-up<##> in Case Form Regulatory Reports Seq column.

3. System uses Case Number (as printed in the Manufacturer Control Number (that is listed in Box 24) of the previously submitted VAERS report) in data elements C.1.1. and C.1.8.1.

If a reporting destination is configured for eVAERS and VAERS reports and if the previous report was sent in eVAERS format and if the subsequent report is scheduled in VAERS PDF format to the same destination:

1. System schedules an initial report by populating Initial' in the Case Form Regulatory Reports Seq column.

2. If any Follow-up reports are scheduled to the same destination at a later point of time, system schedules a follow-up report by populating Follow-up<##> in Case Form Regulatory Reports Seq column.

3. System does not use (C.1.1) from the previously submitted eVAERS report as the Manufacturer Control Number of VAERS report.

Note:
If user tries to generate eVAERS and VAERS in parallel for a Case, then system has different MCN for eVAERS and VAERS reports for the same case.

Downgrade report is scheduled automatically if the Significant F/UP version does not satisfy the Regulatory Reporting Rules defined for eVAERS for a case was submitted in eVAERS.

System auto-schedules Amendment report instead of a follow-up report for a Reporting Destination configured with eVAERS profile, when:

a. eVAERS report was previously submitted to the same Reporting Destination for the same license type

b. if the latest record in the 'Amendment / Follow-up section' of Case Form ' General is an Amendment and the Amendment record was created for previously submitted eVAERS report

System auto-schedules a Nullification report instead of follow-up report for a Reporting Destination configured with eVAERS, under the same conditions ( Case deletion and manually scheduling Nullification from Reports Compliance Submitted Reports Schedule Nullification) as per current functionality on Nullification reports for E2B profiles.

When Nullification report is generated, following data element items have updated values from the previous report.

- N.1.2 batchmessagenumb

- N.1.5 batchmessagedate

- N.2.r.4 messagecreationdate

- C.1.2 transmissiondater3

- C.1.11.1 casenullification

- C.1.11.2 nullificationreason

5.2 Generate Reports

Use the following procedure to generate a scheduled report.

1. E2B, eMDR and eVAERS report scan be manually generated by clicking the draft/final links in the row that corresponds to the scheduled E2B Report in In the Regulatory Reports tab. The report is generated and can be viewed in the ICSR Viewer. If a validation error occurs during E2B report generation, the validation details are stored in the Report Details Dialog.

2. E2B, eMDR and eVAERS reports are generated by AG Services for a locked case which has scheduled 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.

5.3 Attachments in Reports

Case Form Attachments are sent to Reporting Destination with the E2B (R2) report as described below:

1. If attachment classification in the case is specified in the Reporting Destination, system reads such Attachments and converts .XLS, .TXT, .TIF, .DOC, .RTF, .PNG, .JPG or .BMP them into PDF and combine with the PDF attachments if any in the case.

2. The single merged PDF has each attachment which is merged available as a link (bookmark) by the classification name provided for the attached file.

3. Attachments are sent only if there is a E2B report sent out for that Agency. Attachments are not sent for nullification reports.

Note:
While transmitting attachments using the FDA profile in the E2B (R2) format, the system places the attachment file (PDF file created by merging all relevant attachments) in the configured Attachment folder (Reporting Destination > EDI tab > ICSR Attachment Outgoing folder) only after receiving a positive ACK for the ICSR submitted in the E2B (R2) format as an Initial or Follow-up report.
The placement of Attachment files in configured folder after receipt of Positive Ack is done only for E2B (R2) generated using FDA E2B (R2) profile (CFG_PROFILE.AUTHORITY_ID=2.

The system retains the ICSR Attachment in the Outgoing folder if a negative acknowledge is received for an ICSR.

Case Form Attachments are sent to the Reporting Destination with E2B (R3) report as described below:

1. Case Form Attachments are embedded within the ICSR sent in report formats such as E2B (R3), eVAERS and eMDR.

2. Attachments are encoded in the B64 format and sent in the report. The selection of attachments is based on Reporting Destination configuration.

3. Attachments for E2B(R3) are compressed using the compression algorithm configured before embedding them to ICSR. The default algorithm used is DF (Deflate). Attachments are not compressed in eVAERS and eMDR reports.

4. Attachments that were sent out in previous submissions are not sent in Follow-up submission of E2B (R3), eVAERS and eMDR reports (only new and updated attachments are sent in Follow-up reports).

5.4 Transmit Reports

5.4.1 Transmit ICSR Reports

Argus Safety enables you to simultaneously submit multiple adverse event reports to ease the submission process.

After submission of ICSR, the Reporting Destination which receives the ICSR sends MDN and Business Acknowledgment to indicate the status of report acceptance.

The section below describes use of the Bulk Reporting screen to transmit E2B reports and ICSR Transmit Status, ICSR Receive Status and Bulk ICSR transmit screen to track the report submissions and acknowledgement.

5.4.2 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, eMDR or eVAERS.

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. When Expedited reports are selected, the Transmission Comment dialog box is displayed.

7. Click OK to transmit the report(s).
or

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

8. 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.Transmitting Bulk Reports by Form.

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 ICSR 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.

5.4.3 Monitor ICSR Transmit Status

Use the following procedure to monitor ICSR Transmit Status:

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

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

5.4.3.1 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.

5.4.3.2 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.

Acknowledgement Message #

This is the receiver's acknowledgement 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.

ICSR Message Receiver ID

This is the receiver name or identification.

Acknowledgement Message Date

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.

Report Number

This is the report number for adverse event.

Authority /Company Number

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

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."

Report Type

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

Follow up

Nullification

Duplicate

Error Message/Comments

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

5.4.4 Monitor ICSR Receive Status

Use the following procedure to monitor ICSR Receive Status:

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.

5.4.4.1 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.

5.4.4.2 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.

Acknowledgement Message #

This is the receiver's acknowledgement 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.

ICSR Message Receiver ID

This is the receiver name or identification.

Acknowledgement Message Date

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.

Report Number

This is the report number for adverse event.

Authority /Company Number

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

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."

Report Type

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

Follow up

Nullification

Duplicate

Error Message/Comments

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

5.4.4.3 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 ICSR service processes all the incoming messages located in a folder either in incoming EDI directory or physical media directory. Incoming ICSR Messages are retrieved as SGML from a shared directory. The incoming folder is configurable in Argus Interchange Mapping Utility. ICSR 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 ICSR 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 ICSR 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 it through the Argus Interchange Mapping Utility, where all the incoming messages can be stored. The Interchange service processes the received message and moves it in the Archive 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 '2.0', DTD release '1.0', 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

Invalid 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: ICSR 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,

<< ICSR service user >>

- In case the application fails to identify the incoming message:
From: ICSR 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,

<< ICSR service user >>

- In case of validation failure of the incoming acknowledgement:
From: ICSR 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,

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

5.4.5 View Status

Argus Safety provides the feature to monitor the transmission status of E2B, eMDR and eVAERS reports.

Use the following procedure to check the status of transmitted E2B, eMDR and eVAERS reports.

1. Select Worklist -> Bulk ICSR Transmit.

2. Select E2B, eMDR or eVAERS report from the Report drop-down list.

3. Click the Reports tab to view the transmission status of E2B reports.

4. Click the Message tab to view the transmission status of individual E2B messages.

5.4.6 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, eMDR, or eVAERS 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.

6 Use the ICSR Viewer

The ICSR Viewer enables you to open E2B files and view them in different formats.

Note:
The term E2B that is used in this document refers to E2B (R2), E2B (R3), eMDR, and eVAERS reports.

You can print these files from the ICSR viewer.

6.1 Open the ICSR Viewer

The ICSR Viewer enables you to view your E2B reports in the following views:

View

Description

XML

Displays the report in the XML format. This view is applicable for E2B reports.

Decoded View

Displays all the data elements in groups and subgroups. Elements are eligible for decoding with their decoded values in parentheses. A link is provided in the Decoded View to view the attachments that are sent along with the report.
The ICSR Viewer provides the decoded view format for the eVAERS, eMDR, and E2B reports.

For eMDR XML reports, the MedWatch box numbers are displayed instead of Data Element Number.

HL7 View

This view is applicable for only E2B (R3) eMDR and eVAERS reports.This view displays the report in HL7 format.
The data element number and data element description is displayed as a comment for all the data elements that are part of E2B (R3) Regulatory guidelines from ICH, EMA, CDRH, PMDA, and CBER.

CIOMS

For details on the CIOMS view, refer to the E2BCIOMSMapping document. This view is applicable for only E2B (R2) reports.

MedWatch

For details on the MedWatch view, refer to the E2BMedWMapping document. This view is applicable for only E2B (R2) reports.

6.2 Export an XML File

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

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

2. When the system opens the ICSR Viewer window, select XML from the View Format drop-down list.

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

4. When the system displays the XML 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 XML file.

Note:
Exporting an E2B report can only be done from the XML view on final reports. If you select draft, the Export button becomes unavailable.
Besides, these XML files cannot be used for external submissions or transmissions.

7 Import ICSR Reports

7.1 Incoming ICSR Reports

Incoming ICSR Reports can be viewed from the Incoming ICSR Report screen.

This release does not support import of eVAERS.

7.1.1 Import both E2B (R2) and E2B (R3) Messages

The ICSR Import functionality supports the import of both the E2B (R2) and E2B (R3) reports without any data loss of data conversions. To determine if the Sender agency is sending an (R2) or (R3) message, the application relies on the configured E2B profile for the receiving Agency in the Argus Console.

Once the application identifies the message type, the incoming message is processed in accordance with message type and the profile so that the respective data element mappings are executed to extract the data without any data loss.

The application provides the OOTB profile to import ICH, PMDA, EMA & FDA E2B (R2) message, and the EMA & PMDA E2B (R3) message.

Note:
If the incoming message is identified as ICH E2B (R3) message, application downgrades it to ICH E2B (R2) before importing it into the system.

7.1.2 ICSR Import Framework

ICSR Import framework for (R3) import has been designed to provide greater flexibility with respect to (R2) import. It facilitates the user in extending, configuring and customizing the Import profile in such a way that broader use cases for importing data leveraging the ICSR import framework can be met.

The Import framework has been designed to achieve more flexibility by extending, configuring and customization the profile for the following:

1. Extensible ICSR Profile framework: With the current ICSR (R2) framework, E2B+ allows the user to extend the profile elements. However, extending a profile using the existing Framework has certain limitations:

- Linking of extended child with the Parent: If the element is added to the node which is lower in the report hierarchy, linking of the extended node becomes difficult with the higher level node.
For example:

Level 1: SAFETYREPORT

Level 2: PATIENT

Level 3: Drug

Level 4: Dosage

Now, if the user wants to extend an element at Dosage level using E2B+, then the linking of that attribute with the Drug becomes complex and at times could error prone.

- Cannot add a new Parent/repeater: Using the current E2B+ framework it is not feasible to add a new repeater section that is not part of the standard E2B report.

2. Minimum Case creation validations on Incoming ICSR: MAH uses Argus Safety for capturing data from different sources to meet their regulatory and non-regulatory reporting needs. ICSR Import is a big platform for data capturing from various sources. MAH are expected to use Argus as an importing platform to pull the information from various sources in their Safety database and then further process it using Argus for coping with regulatory and non-regulatory purposes.

Note:
All the compliance validation is maintained in the error/warning log for user to review the regulatory gaps with the incoming ICSR file.

3. Import F/U on non-E2B compliant Case: The usage of the ICSR Import framework in not confined to regulatory purposes only - the purpose of the incoming ICSR file can be just the data exchange. Therefore, there can be a scenario where the case on which the ICSR is being imported may not be regulatory complaint but the user would like to import the update from the incoming ICSR. Therefore, the application will not execute the ICSR conformance validation check before importing the data from Follow-up ICSR.

4. Provide flexibility to user to map Incoming ICSR as Follow-up to the existing case: As the usage of the ICSR Import framework in not confined to regulatory purposes, the logic to link an incoming report to the report with an existing case is configurable at the profile level.

5. Comparison and data evaluation/update for an incoming Follow-up report: As per the current implementation for comparing the Incoming ICSR file, the application provides the user a three view difference in the ICSR format:

- Newly imported ICSR message

- ICSR message generated using the current case data against the ICSR profile for the importing agency

- Last imported ICSR file to the case

This comparison logic performs a record matching based on the metadata of the internal table by performing the key based comparison of the elements in the above three ICSR files. The comparison logic can be configured by modifying the internal metadata to a certain extent with several limitations. The existing comparison and data updation logic has been enhanced for the following:

a Support deletion of unwanted data after F/U

b Flexibility in Primary key identification for F/U records

c Special use case to support comparison based on External applications entity Identifier

d Customizable comparison and updation for handling exceptional use scenarios (User Exits)

For more details, from the Argus Safety OHC">>Argus Safety OHC page, download the Technical Reference Manuals, and refer to the >Oracle Argus Interchange ICSR Extensibility Guide.

7.1.3 Interchange Accept Process

This section is specific to the E2B (R3) Import.

The application function flow for importing (R3) based ICSR messages in the Interchange accept process is similar to that of the (R2) except for the updates specified in this section.

Note:
Any xsd/xslt/dtd validations that may apply to any of the internal processing/ massaging/ transformations of the xml message are configurable at profile level.

- The application supports importing of batch (R3) messages consisting of more than one report.

- The maximum file size allowed to be imported into Argus respects the value configured in Argus Console -> Reporting Destination -> EDI -> Allowed report size (in MB) for the receiving Agency.

- The Interchange Accept process performs the following validations on the incoming (R3) message:
Hard Validation: In case of a validation error under this category, the Interchange Accept process rejects the incoming message and generates a negative ACK with the required error message. For more information on ACK mapping details, refer to the ACK element level mappings. The following are the categories of hard validations:

1. Length validation

2. Code list data validations

3. Minimum case creation validation

Soft Validation: In case of a validation error under this category, the Interchange Accept process does not reject the incoming message. Instead, the process maintains a log of errors under this category for future reference in the ICSR Pending screen (for more details, refer to the ICSR Pending screen) and in the Case Attachment (for more details, refer Case creation/updation section). The following are the categories of soft validations:

1. Element Conformance validation

2. Mandatory along with validation

3. Additional validation

The logic to identify the case over which the Incoming (R3) ICSR message is imported as a Follow-up is configurable at the profile level.

- The accept process loads all the data from the incoming (R3) based ICSR message to staging schema without any data loss.

- The application logic to identify the Agency whose profile configuration is used during the import of the (R3) based ICSR message is as follows:

1. Reporting Destination'EDI'Agency Identifier: N.1.3-BATCHMESSAGESENDERIDENTIFIER / N.2.r.2 - MESSAGESENDERIDENTIFIER

2. Reporting Destination'EDI'Company Identifier: N.1.4-BATCHMESSAGERECEIVERIDENTIFIER / N.2.r.3 - MESSAGERECEIVERIDENTIFIER

3. Reporting Destination'EDI' Primary Receive Agency: Checked

- All the respective statuses that are applicable for the existing (R2) message have been updated for the (R3) message in a similar manner. These statuses can be tracked in various screen in Argus UI such as Reports > ICSR Pending (Pending & processed tabs) & Utilities > ICSR > ICSR Receive Status).

- Duplicate (R3) message identification is governed based on the value in the N.1.2 -BATCHMESSAGENUMB tag.

- The existing application to identify the Initial/Follow-up/Downgrade/Nullification has been enhanced to identify the Amendment report based on the C.1.11.1- CASENULLIFICATION. The amendment identification is only applicable for (R3) message as the concept of amendment report is specific to (R3) reports only.

- The acceptance process every stage of import evaluates the various import stages and generates the ACK in the (R3) format.

7.1.4 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 ICSR 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.

7.1.4.1 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.

7.1.5 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 ICSR 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.

7.1.5.1 Display 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.

7.1.6 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. You can also view an E2B report from the ICSR Pending screen by right-clicking on a row and selecting ICSR Viewer.

7.1.7 Accept Single or Multiple E2B Reports

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

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

2. When the system opens the ICSR Pending screen:
To accept a single report, right-click on it and select Accept E2B

OR

To accept multiple reports, select the check boxes for each report and click Accept E2B.

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:
The acceptance of multiple E2Bs 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.

7.1.8 E2B Initial or 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 accept 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.

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

- 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 (ICSR 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 #: XXXXX

where:

XXXXX 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.

- 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.

7.1.9 E2B Follow-up Acceptance for Closed or 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 case is in archived state while you are accepting the report, the system displays the Case Re-open Dialog to enable you to open the case.

- If the case is in locked state while you are accepting a report, the system displays the Case Unlock Dialog to enable you to unlock the case.

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

- If 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.

7.2 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

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.

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