Oracle® Argus Interchange User’s Guide Release 7.0.2 E35664-01 February 2013 Oracle Argus Interchange User's Guide Release 7.0.2 E35664-01 Copyright © 2013 Oracle and/or its affiliates. All rights reserved. This software and related documentation are provided under a license agreement containing restrictions on use and disclosure and are protected by intellectual property laws. Except as expressly permitted in your license agreement or allowed by law, you may not use, copy, reproduce, translate, broadcast, modify, license, transmit, distribute, exhibit, perform, publish, or display any part, in any form, or by any means. Reverse engineering, disassembly, or decompilation of this software, unless required by law for interoperability, is prohibited. The information contained herein is subject to change without notice and is not warranted to be error-free. If you find any errors, please report them to us in writing. 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Contents Preface................................................................................................................................................................. vi Audience....................................................................................................................................................... vi Documentation Accessibility..................................................................................................................... vi Related Documents..................................................................................................................................... vi Checking My Oracle Support................................................................................................................... vii Conventions................................................................................................................................................ vii 1 About Argus Interchange Argus Interchange Process Overview.................................................................................................. 1-1 2 Configuring Argus Interchange ESM Mapping Utility.............................................................................................................................. 2-1 Logging On and Off Interchange..................................................................................................... 2-2 Logging On to Interchange........................................................................................................ 2-2 Exiting from Interchange........................................................................................................... 2-3 Working with Profiles....................................................................................................................... 2-3 Defining a Profile........................................................................................................................ 2-3 Using the Transmit Tab...................................................................................................... 2-4 Printing a Profile......................................................................................................................... 2-4 Setting Up the Printer.......................................................................................................... 2-4 Printing a Profile.................................................................................................................. 2-5 Copying a Profile........................................................................................................................ 2-6 Deleting a Profile......................................................................................................................... 2-7 Viewing Regulatory Authorities/Trading Partners..................................................................... 2-7 Configuring Argus Interchange Service......................................................................................... 2-8 Service INI File Setup Dialog Box............................................................................................. 2-9 Adding a Database for Argus Interchange Service....................................................................... 2-9 Service DB Setup Fields.......................................................................................................... 2-10 Viewing the Audit Log................................................................................................................... 2-12 Audit Log Dialog Box Fields.................................................................................................. 2-13 Comparing DTD Profiles............................................................................................................... 2-13 Compare Profile Dialog Box Fields....................................................................................... 2-15 E2B Codes Translation.................................................................................................................... 2-16 E2B Codes Translation Fields................................................................................................. 2-16 Configuring E2B Codes Translation...................................................................................... 2-16 iii E2B Extensions................................................................................................................................. 2-17 Web Console........................................................................................................................................... 2-19 Configuring Regulatory Authorities............................................................................................ 2-19 EDI Tab Fields.......................................................................................................................... 2-20 Configuring SMTP.......................................................................................................................... 2-22 SMTP Configuration Dialog Box Fields................................................................................ 2-23 Configuring Code List Items......................................................................................................... 2-23 Configuring an Action Taken................................................................................................. 2-23 Configuring Age Groups........................................................................................................ 2-24 Configuring Age Units............................................................................................................ 2-25 Configuring Attachment Classifications.............................................................................. 2-25 Configuring Dosage Units...................................................................................................... 2-26 Configuring an Event Outcome............................................................................................. 2-27 Configuring Gender................................................................................................................ 2-27 Configuring Report Type........................................................................................................ 2-28 Configuring Reporter Type.................................................................................................... 2-29 Configuring Routes of Administration................................................................................. 2-29 Configuring a Message Type................................................................................................. 2-30 E2B Length Check.................................................................................................................... 2-31 3 E2B Check Why perform an E2B Check?................................................................................................................. 3-1 4 Transmitting and Monitoring E2B Reports Logging In and Out of Argus Safety.................................................................................................... 4-1 To Log Out of the Argus Application............................................................................................. 4-2 Scheduling an E2B Report...................................................................................................................... 4-2 New Expedited Report Dialog Fields............................................................................................. 4-3 Viewing a Scheduled E2B Report......................................................................................................... 4-5 Transmitting E2B Reports....................................................................................................................... 4-5 Transmitting Bulk Reports by Form................................................................................................ 4-5 Monitoring E2B Transmit Statuses.................................................................................................. 4-7 E2B Transmit Status Fields........................................................................................................ 4-8 Message Acknowledgement Status Dialog Fields................................................................. 4-9 Monitoring E2B Receive Statuses................................................................................................. 4-10 E2B Receive Status Dialog Fields........................................................................................... 4-10 Message Acknowledgement Status Dialog Fields.............................................................. 4-11 Validation Check of Incoming Message............................................................................... 4-12 Nullification Reports...................................................................................................................... 4-14 Viewing Statuses............................................................................................................................. 4-16 Viewing Acknowledgement Information.................................................................................... 4-17 5 Using the E2B Viewer Opening the E2B Viewer......................................................................................................................... 5-1 Exporting an SGML File......................................................................................................................... 5-2 iv 6 Importing E2B Reports Incoming E2B Reports............................................................................................................................. 6-1 Searching for Duplicate Cases.......................................................................................................... 6-1 Duplicate Search Dialog Box Fields......................................................................................... 6-1 Using the View Differences Report................................................................................................. 6-3 Displaying Differences............................................................................................................... 6-4 Viewing the E2B Report.................................................................................................................... 6-4 Accepting Single/Multiple E2B Reports........................................................................................ 6-4 E2B Initial/Follow-up Intake........................................................................................................... 6-5 E2B Follow-up Acceptance for Closed/Locked Cases................................................................. 6-7 Processed E2B Reports............................................................................................................................. 6-7 v Preface This Guide provides documentation on the tasks related to the handling of E2B reports in Argus Safety. These include configuration, validation, viewing, transmitting, monitoring and import of E2B reports. Audience This document is intended for the users and administrators of the Argus Interchange application. 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 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. Related Documents This section lists the manuals for Oracle Argus products. You can order printed manuals from the Oracle iStore. Oracle Argus Documentation The documentation set includes: ■ Oracle Argus Safety User's Guide ■ Oracle Argus Safety Administrator's Guide ■ Oracle Argus Safety Database Administrator's Guide ■ Oracle Argus Dossier User's Guide ■ Oracle Argus Affiliate User's Guide ■ Oracle Argus Unblinding User's Guide vi ■ Oracle Argus Interchange UICH DTD 2.1 Mapping Reference Guide Checking My Oracle Support The Oracle Argus Safety product suite continues to grow and evolve. To help you use it and stay abreast of updates we provide between releases, it is a good practice to check My Oracle Support for information that enhances our released documentation. To open the Oracle Argus Safety product page on My Oracle Support, complete the following steps: 1. Open a Web browser to http:/support.oracle.com. 2. Click Sign In and enter your user information. The My Oracle Support portal opens, displaying general news from several categories. If you do not yet have an account, click Register here and follow the instructions given on the registration page. 3. Click Knowledge. 4. In the Browse any Product, by Name field, enter Oracle Argus Safety. 5. Click Go. My Oracle Support loads the Oracle Argus Safety Knowledge Browser Product Page. Conventions The following text conventions are used in this document: Convention Meaning boldface Boldface type indicates graphical user interface elements associated with an action, or terms defined in text or the glossary. italic Italic type indicates book titles, emphasis, or placeholder variables for which you supply particular values. monospace Monospace type indicates commands within a paragraph, URLs, code in examples, text that appears on the screen, or text that you enter. vii 1 About Argus Interchange 1 Argus Interchange provides pharmaceutical manufacturers with a simple, efficient way to comply with electronic standards for transferring regulatory information through the use of an Electronic Data Interchange (EDI) gateway. It also enables you to view E2B reports in different formats, such as SGML, CIOMS, and MedWatch. These reports can be submitted to trading partners or to regulatory authorities. Argus Interchange Process Overview The following flowchart shows the steps to follow when using Argus Interchange. The following table describes each of the steps in the preceding flowchart. Task Description Logging on Explains how to log on to Argus Safety. Schedule E2B Report Explains how to schedule an E2B Report for a case using the New Expedited Report dialog. View E2B Report Explains how to view a scheduled E2B Report in the E2B viewer and check for validation errors. Transmit E2B Report Explains how to transmit E2B reports by using the Bulk Reporting features in Argus Safety. View Statuses Explains how to view and understand the status of a transmitted E2B report. View Acknowledgement Explains how to view the detailed acknowledgement information from a trading partner or a regulatory authority. About Argus Interchange 1-1 2 Configuring Argus Interchange 2 This section is intended for Argus Interchange Administrators. The flowchart shows the steps to follow when configuring, reviewing, and administering Argus Interchange. ESM Mapping Utility The ESM Mapping Utility enables you to store multiple profiles. This enables companies to transmit E2B reports to multiple agencies. The ESM Mapping Utility maintains an audit log that tracks every change made to the settings. You can also use this utility to view Trading Partner Configurations. This chapter includes discussions of the following: ■ Logging On and Off Interchange ■ Viewing Regulatory Authorities/Trading Partners ■ Configuring Argus Interchange Service ■ Adding a Database for Argus Interchange Service ■ Viewing the Audit Log ■ Comparing DTD Profiles ■ E2B Codes Translation ■ E2B Extensions Configuring Argus Interchange 2-1