Oracle® Argus Safety Installation Guide Release 7.0 E20622-01 April 2011 Oracle Argus Safety Installation Guide, Release 7.0 E20622-01 Copyright © 2011 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................................................................................................................................................................. ix Intended Audience...................................................................................................................................... ix Documentation Accessibility..................................................................................................................... x About This Book.......................................................................................................................................... x Related Documents..................................................................................................................................... xi Checking My Oracle Support................................................................................................................... xii Conventions................................................................................................................................................ xii 1 Introduction 1.1 General Installation and Software Requirements.................................................................. 1-1 1.2 Pre-Requisite Installation Order............................................................................................... 1-1 1.2.1 Argus Safety Database Server Installation Requirements............................................. 1-2 1.2.1.1 Oracle Considerations.................................................................................................. 1-2 1.2.2 Argus Safety Web Server Installation Requirements..................................................... 1-2 1.2.3 Argus Safety Report Server Installation Requirements................................................. 1-3 1.2.4 Argus Transaction Server Installation Requirements.................................................... 1-4 1.2.5 Argus Interchange Server Requirements......................................................................... 1-5 1.2.6 Argus Safety Web Client Installation Requirements...................................................... 1-6 1.2.7 Argus Safety Dossier Web Client Installation Requirements........................................ 1-7 1.2.8 Argus End of Study Unblinding Tool (EOSU) Installation Requirements................. 1-7 1.2.9 Argus Multi-Tenant Portal Server Requirements........................................................... 1-7 1.3 Argus Safety Hardware Topology........................................................................................... 1-8 1.3.1 Recommended Hardware Topology for a Small Company.......................................... 1-8 1.3.2 Recommended Hardware Topology for a Mid-sized Company.................................. 1-8 1.3.3 Recommended Hardware Topology for a Large Company.......................................... 1-9 1.4 General Pre-Installation Tasks.................................................................................................. 1-9 1.5 Installation Process Overview................................................................................................ 1-10 2 Starting the Installation 2.1 Getting Started............................................................................................................................. 2-1 2.2 Installing the Files Required to View Japanese Text.............................................................. 2-1 3 Installing the Argus Safety Database 3.1 Overview...................................................................................................................................... 3-1 3.2 Schemas Required for Database Instances.............................................................................. 3-1 iii 3.2.1 Argus Safety Instance Database Schemas........................................................................ 3-2 3.2.2 Argus DLP Instance (Optional)......................................................................................... 3-2 3.2.3 Axway Synchrony Database Instance (Optional)........................................................... 3-2 3.3 Setting up Oracle Parameters.................................................................................................... 3-2 3.3.1 Oracle 11g Database Settings............................................................................................. 3-2 3.3.1.1 Argus Safety Database Instance Parameters............................................................ 3-3 3.3.1.2 Argus Safety Database I/O Configuration............................................................... 3-3 3.3.1.3 Oracle Instance Settings............................................................................................... 3-4 3.3.1.4 OPTIMIZER_SECURE_VIEW_MERGING............................................................... 3-4 3.3.1.5 JOB_QUEUE_PROCESSES.......................................................................................... 3-4 3.3.2 GMT Offset Calculation...................................................................................................... 3-5 3.4 Prerequisites for New Schema Creation................................................................................. 3-6 3.4.1 Creating the Argus Safety Database Schema................................................................... 3-6 3.4.1.1 XDB Schema Installation Requirement for Interchange......................................... 3-7 3.4.1.2 Installing the Schema Creation Tool.......................................................................... 3-7 3.4.1.3 Creating the Tablespaces............................................................................................. 3-7 3.4.1.4 Creating the Schema..................................................................................................... 3-7 3.5 Loading Factory Data.............................................................................................................. 3-16 3.6 Enabling and Disabling Oracle Text..................................................................................... 3-17 3.6.1 Enabling Oracle Text........................................................................................................ 3-17 3.6.2 Disabling Oracle Text....................................................................................................... 3-19 3.7 Implementing Table Partitioning.......................................................................................... 3-21 3.8 Loading the MedDRA and MedDRA J Dictionaries........................................................... 3-21 3.8.1 Loading the MedDRA Dictionary.................................................................................. 3-21 3.8.1.1 Overwriting an Existing MedDRA Dictionary...................................................... 3-25 3.8.1.2 Recoding Events........................................................................................................ 3-28 3.8.2 Loading the J Drug Dictionary....................................................................................... 3-32 3.8.3 Overwriting an Existing MedDRAJ Dictionary........................................................... 3-34 3.8.3.1 Recoding Events........................................................................................................ 3-36 3.9 Loading the WHO-DRUG Dictionary................................................................................... 3-40 3.9.1 Loading the WHO-Drug Dictionary to New Tables................................................... 3-41 3.9.2 Loading the WHO-Drug Dictionary Using the Overwrite Option........................... 3-44 3.9.3 To Load the WHO-Drug Dictionary using the Format C Option.............................. 3-45 3.10 Validating the Argus Safety Database.................................................................................. 3-46 3.11 Enabling and Disabling DLP.................................................................................................. 3-47 3.11.1 Prerequisites...................................................................................................................... 3-47 3.11.2 Enabling DLP.................................................................................................................... 3-47 3.11.3 Disabling DLP................................................................................................................... 3-54 3.12 Upgrading the Argus Safety Database................................................................................. 3-56 3.12.1 Prerequisites...................................................................................................................... 3-57 3.12.2 Argus Upgrade from Safety versions prior to AS 6.0.1 / AS 6.0.1.1......................... 3-57 3.12.3 Database Upgrade Procedure (with or Without DLP) from AS 6.0.1 to AS 7.0...... 3-59 3.13 Merging a Single Enterprise Safety Database into a Multi-tenant Database.................. 3-68 3.13.1 Prerequisites to Running the Merge Export Step......................................................... 3-68 3.13.2 Prerequisites to Running the Merge Import Step........................................................ 3-68 3.13.3 Completing the Merge Process....................................................................................... 3-68 3.13.3.1 Merge Export.............................................................................................................. 3-68 iv 3.13.3.2 Exporting the dmp File Copy to the Target Database Server............................. 3-69 3.13.3.3 Merge Import............................................................................................................. 3-69 3.13.3.4 Manual Dictionary Synchronization....................................................................... 3-70 3.14 Copy Configuration Tool........................................................................................................ 3-71 4 Installing Argus Safety Web 4.1 Installing Argus Safety Web...................................................................................................... 4-1 4.2 Adding the Argus Site as a Trusted Site.................................................................................. 4-9 4.3 Configuring the IIS Manager for Windows 2008................................................................... 4-9 4.4 Connecting to a Domain Account on Windows 2008......................................................... 4-11 4.5 Enabling SSL Support for Windows 2008............................................................................ 4-13 4.6 Configuring Load Balancer in Argus Web........................................................................... 4-14 4.6.1 Setup Argus Web Load Balancer IP Address............................................................... 4-14 4.6.2 Set up load balanced folders........................................................................................... 4-14 4.6.3 Set up the shared network directory ............................................................................. 4-14 4.7 Installing Argus Report Server.............................................................................................. 4-14 4.8 Securing Sensitive Configuration and Operational Data................................................... 4-15 4.9 Configuring Identity in the IIS Application Pools.............................................................. 4-16 4.10 Resetting IIS.............................................................................................................................. 4-16 5 Installing Argus Safety Service 5.1 Starting Argus Safety Service.................................................................................................... 5-3 5.2 Setting up RightFax.................................................................................................................... 5-6 6 Installing and Configuring EDI Gateway 6.1 Creating a Axway Synchrony Database Instance.................................................................. 6-1 6.2 Installing Axway Synchrony Interchange............................................................................... 6-2 6.3 Starting the Axway Synchrony Server..................................................................................... 6-4 6.4 Configuring Axway Synchrony Interchange.......................................................................... 6-5 6.5 Configuring Axway Synchrony for Binary File Transmission............................................. 6-6 6.6 Configuring Axway Synchrony Community......................................................................... 6-8 6.6.1 Registering with the Axway Synchrony Community.................................................... 6-8 6.6.2 Adding a Partner to the Axway Synchrony Community.............................................. 6-8 6.6.2.1 Registering the Receiver's Community on the Sender Server............................ 6-10 6.7 Adding a Node......................................................................................................................... 6-10 6.8 Configuring Axway Synchrony Certificates........................................................................ 6-10 6.8.1 Configuring Receiver Axway Synchrony Certificates................................................ 6-11 6.8.2 Configuring Sender Axway Synchrony Certificates................................................... 6-11 6.9 Configuring EVENTS.XML.................................................................................................... 6-13 6.10 Testing Communication.......................................................................................................... 6-15 7 Installing and Configuring Interchange 7.1 Installing Interchange Service................................................................................................... 7-1 7.2 Configuring Interchange Service.............................................................................................. 7-6 7.2.1 Transmitting E2B Attachments.......................................................................................... 7-6 v 7.3 Accessing EDI Gateway Shared Folders................................................................................. 7-6 7.4 Configuring the Interchange Service.INI File......................................................................... 7-7 8 Performing Post-installation Checks 8.1 Post-Installation Tasks............................................................................................................... 8-1 8.1.1 General Checklist................................................................................................................. 8-1 8.1.2 Configuring Argus Safety Windows Service to run as a Domain User....................... 8-2 8.1.3 Configure Worklist Intake.................................................................................................. 8-2 8.1.4 IIS Checklist.......................................................................................................................... 8-4 8.1.5 .INI File Checklist................................................................................................................ 8-5 8.1.6 Service Checklist.................................................................................................................. 8-5 8.2 Verifying the Web Server Installation and IIS Configurations............................................ 8-5 8.2.1 Verifying IIS 7 Configuration............................................................................................. 8-6 8.3 Configure and Verify the Dossier Installation........................................................................ 8-6 8.3.1 Configuring the Dossier Application................................................................................ 8-6 8.3.2 Verifying the Dossier Installation...................................................................................... 8-7 8.4 Verify Files installed on Middle Tier Servers:........................................................................ 8-8 8.5 Verifying the Documentum Installation.................................................................................. 8-8 8.6 Validating the easyPDF Installation......................................................................................... 8-9 8.6.1 Validating the easyPDF Installation for Word 2007....................................................... 8-9 9 Enabling IIS HTTP Compression 9.1 IIS Web Page Compression....................................................................................................... 9-1 9.1.1 HTTP Compression............................................................................................................. 9-1 9.1.2 Known Effects of Enabling Compression........................................................................ 9-1 9.1.3 How to Enable HTTP Compression.................................................................................. 9-2 9.2 IIS Caching Settings.................................................................................................................... 9-2 9.2.1 IIS Caching............................................................................................................................ 9-2 9.2.2 Known Effects of Enabling Caching................................................................................. 9-2 9.2.3 How to Enable Caching...................................................................................................... 9-2 9.3 Local Internet Explorer (IE) Client Caching Settings............................................................. 9-3 9.3.1 IE Client Caching................................................................................................................. 9-3 9.3.2 IE Client Caching Tab Options.......................................................................................... 9-3 9.3.3 How to Enable IE Caching................................................................................................. 9-4 10 Configuring E-mail 10.1 About E-mail Configuration................................................................................................... 10-1 10.2 Configuring SMTP................................................................................................................... 10-1 10.2.1 Using the SMTP Configuration Utility.......................................................................... 10-1 10.2.2 Functions Affected by SMTP........................................................................................... 10-2 10.2.2.1 Bulk Report Transmit E-mail................................................................................... 10-2 10.2.2.2 Autosignal E-mail...................................................................................................... 10-3 10.2.2.3 Fax E-mail................................................................................................................... 10-3 10.2.2.4 Fax Status E-mail....................................................................................................... 10-3 10.2.2.5 Priority E-mail............................................................................................................ 10-3 10.2.2.6 Dossier Notification E-mail...................................................................................... 10-3 vi 10.2.2.7 E-mail Sent by Interchange Service......................................................................... 10-3 11 Installing End of Study Unblinding 11.1 EOSU Hardware/Software Requirements........................................................................... 11-1 11.2 How to Install the EOSU Utility............................................................................................ 11-2 12 Other Tasks 12.1 Configuring the Argus.xml File............................................................................................. 12-1 12.2 Configuring the Argus.ini File............................................................................................... 12-2 12.3 Deploying a Portlet on Oracle WebLogic Server................................................................. 12-5 12.4 Deploying the Global Home Application on a WebLogic Server .................................... 12-8 12.4.1 Configure Global Homepage Properties File............................................................... 12-8 12.4.1.1 Update Global Homepage Properties File............................................................. 12-8 12.4.1.2 Deploy Company Logo............................................................................................. 12-9 12.4.2 Pre-Deployment Configuration...................................................................................... 12-9 12.5 Configuring SSO in Oracle Access Manager..................................................................... 12-14 12.5.1 Installing WebGate......................................................................................................... 12-18 12.5.2 Configuring WebGate on Windows Server 2008....................................................... 12-23 12.5.3 Protecting Files in the Argus Directory....................................................................... 12-27 12.6 Installation and Configuration of Oracle Web Tier Suite................................................ 12-33 12.6.1 Installing Oracle Web Tier............................................................................................. 12-34 12.6.2 Configuring Oracle Web Tier........................................................................................ 12-36 12.6.3 Oracle Http Server Administration.............................................................................. 12-40 12.6.4 Configuring Oracle Http Server as Reverse Proxy Server for WebLogic............... 12-41 12.7 Configuring the WebCenter Security Provider for Identity Assertion.......................... 12-42 12.7.1 Configuring the Oracle Internet Directory Authenticator........................................ 12-42 12.7.2 Configuring the OAM Identity Asserter..................................................................... 12-45 12.7.3 Configuring the Default Authenticator and Setting the Order of Providers......... 12-47 12.7.4 Setting EXTRA_JAVA_PROPERTIES for WebLogic Domain.................................. 12-47 12.8 Installation Maintenance Tasks............................................................................................ 12-48 12.8.1 Installing New Components......................................................................................... 12-48 12.8.2 Uninstalling Components.............................................................................................. 12-49 12.8.3 Removing All Components........................................................................................... 12-49 12.9 Web Client Tips...................................................................................................................... 12-50 12.10 Clearing Oracle Temp Files.................................................................................................. 12-51 12.11 Configuring easyPDF............................................................................................................ 12-52 12.11.1 Setting Up easyPDF........................................................................................................ 12-52 12.11.2 Setting up Microsoft Office........................................................................................... 12-53 12.12 Setting Printer Defaults......................................................................................................... 12-53 12.13 Argus Configuration Files.................................................................................................... 12-54 13 Argus Integrations 13.1 Installing Argus Integrations................................................................................................. 13-1 13.2 Resetting IIS.............................................................................................................................. 13-3 13.3 General Interface Information................................................................................................ 13-3 13.4 Basic Configuration Overview............................................................................................... 13-3 vii 13.5 Safety Message......................................................................................................................... 13-4 13.6 MedDRA Integration............................................................................................................... 13-4 13.6.1 Flow of MedDRA Auto Encoding.................................................................................. 13-5 13.6.2 MedDRA Auto-Encoding Safety Message Example................................................... 13-5 13.6.3 Configuration.................................................................................................................... 13-7 13.7 Product License Study Interface............................................................................................ 13-7 13.8 Drug Dictionary Integration................................................................................................... 13-8 13.8.1 Flow of Drug Dictionary Coding.................................................................................... 13-8 13.8.2 Drug Dictionary Coding Safety Message Example..................................................... 13-9 13.8.3 Configuration.................................................................................................................. 13-10 13.9 Lot Number Interface............................................................................................................ 13-11 13.9.1 Flow of Lot Validation................................................................................................... 13-11 13.9.2 Lot Validation Safety Message Example..................................................................... 13-11 13.9.3 Configuration.................................................................................................................. 13-12 13.10 Worklist Intake....................................................................................................................... 13-14 13.10.1 Flow of Worklist Intake................................................................................................. 13-14 13.10.2 Worklist Intake Safety Message Example................................................................... 13-14 13.10.3 Configuration.................................................................................................................. 13-16 13.11 Literature Intake..................................................................................................................... 13-17 13.11.1 Flow of Literature Intake............................................................................................... 13-17 13.11.2 Configuration.................................................................................................................. 13-18 13.11.2.1 Metadata Configuration......................................................................................... 13-18 13.12 Extended E2B Interface......................................................................................................... 13-19 13.12.1 E2B Mapping Updates................................................................................................... 13-19 13.12.2 Add Extension Elements to DTD................................................................................. 13-19 13.12.3 Prepare Factory Data for Extension Elements............................................................ 13-21 13.12.4 Create Business Logic for Extension Elements........................................................... 13-23 13.12.5 Configure Reporting Destination for Extension Profile............................................ 13-23 13.12.6 Extension Elements Sample XML................................................................................. 13-24 13.12.7 Extension Elements Sample Import PL/SQL Block.................................................. 13-24 A Third Party Attributions viii Preface This guide describes installing — or upgrading to — Oracle Argus Safety 7.0. Keep this guide; you perform some of these tasks once, but others you repeat as your system changes or grows. Intended Audience We wrote this manual assuming your organization has the expertise to perform the job functions listed in this section. If your staff lacks these skills, we recommend that you engage Oracle Consulting. Oracle Database Administrators Installing Oracle Argus Safety requires a level of knowledge equivalent to having mastered the material in Oracle's DBA Architecture and Administration course. You must be able to read SQL*Plus scripts and edit them. You must be able to run SQL scripts and review logs for Oracle errors. For ongoing administration, additional training as a DBA is essential. System Administrators Installing and maintaining an Oracle Argus Safety network requires mastery of the following skills: ■ Microsoft Windows operating systems, in general – creating and managing user accounts and groups – installing Oracle software – managing settings through the Control Panel – managing network printers – creating services ■ UNIX: – creating and managing user accounts and groups – installing Oracle RDBMS software and patches – identifying space on a file system for Oracle database tablespaces – setting and using environment variables ix Documentation Accessibility Our goal is to make Oracle products, services, and supporting documentation accessible to all users, including users that are disabled. To that end, our documentation includes features that make information available to users of assistive technology. This documentation is available in HTML format, and contains markup to facilitate access by the disabled community. Accessibility standards will continue to evolve over time, and Oracle is actively engaged with other market-leading technology vendors to address technical obstacles so that our documentation can be accessible to all of our customers. For more information, visit the Oracle Accessibility Program Web site at http://www.oracle.com/accessibility/ Accessibility of Code Examples in Documentation Screen readers may not always correctly read the code examples in this document. The conventions for writing code require that closing braces should appear on an otherwise empty line; however, some screen readers may not always read a line of text that consists solely of a bracket or brace. Accessibility of Links to External Web Sites in Documentation This documentation may contain links to Web sites of other companies or organizations that Oracle does not own or control. Oracle neither evaluates nor makes any representations regarding the accessibility of these Web sites. TTY Access to Oracle Support Services To reach Oracle Support Services, use a telecommunications relay service (TRS) to call Oracle Support at 1.800.223.1711. About This Book This guide contains these chapters: Chapter1, "Introduction" This section provides an overview of the hardware and software requirements for Oracle Argus Safety. Chapter2, "Starting the Installation" This section provides information about starting the installation. Chapter3, "Installing the Argus Safety Database" This section describes the steps in creating, upgrading, and validating the Argus Safety Database schema. Chapter4, "Installing Argus Safety Web" This section describes how to install Argus Safety Web and Argus Report Server, and how to configure IIS Manager and Load Balancer. Chapter5, "Installing Argus Safety Service" This section provides instructions on installing Argus Safety Service. x