Oracle® Argus Safety [1] Installation Guide Release 8.2 E96569-01 August 2018 Oracle Argus Safety Installation Guide, Release 8.2 E96569-01 Copyright © 2018 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............................................................................................................................................................... xiii Where to Find More Information............................................................................................................ xiii Documentation Accessibility................................................................................................................... xiii Part I Prepare to Install Argus Safety 1 System Requirements 1.1 Hardware Requirements for Argus Safety.............................................................................. 1-1 1.2 Software Requirements for Argus Safety................................................................................ 1-2 1.2.1 Operating System................................................................................................................ 1-2 1.2.2 Oracle Components............................................................................................................. 1-2 1.2.3 Other Components.............................................................................................................. 1-4 1.2.4 Generic—Other Supported Features................................................................................ 1-4 2 Install Oracle Database 2.1 Get the Oracle Database Installation Guide............................................................................ 2-1 2.2 Download and Extract the Oracle Database Software.......................................................... 2-1 2.3 Install Oracle Database............................................................................................................... 2-1 2.3.1 Database Software Installation Options........................................................................... 2-1 2.3.2 Database Configuration Options....................................................................................... 2-2 2.3.3 Register ODP.NET in Windows Global Assembly Cache (GAC)................................ 2-2 2.3.4 Oracle Advanced Security Transparent Data Encryption (TDE).................................. 2-3 2.3.5 Install and Apply Oracle Patch Set................................................................................... 2-3 2.4 Set Up Database Parameters..................................................................................................... 2-3 2.4.1 Argus Safety Database Instance Parameters (Recommended)..................................... 2-3 2.4.2 Additional Database Setup Information.......................................................................... 2-4 2.5 GMT Offset Calculation............................................................................................................. 2-4 2.6 Table Partitioning (Optional).................................................................................................... 2-5 Part II Set Up Argus Safety Middle and Client Tiers 3 Install and Configure Argus Safety Web 3.1 Prerequisites................................................................................................................................ 3-1 3.2 Install IIS....................................................................................................................................... 3-1 iii 3.3 Install Argus Safety Web........................................................................................................... 3-2 3.4 Configure the IIS Manager for Windows Server.................................................................... 3-3 3.5 Enable SSL Support for Windows Server................................................................................ 3-4 3.6 Configure Load Balancer in Argus Web.................................................................................. 3-4 3.6.1 Set Up Argus Web Load Balancer IP Address................................................................ 3-4 3.6.2 Set Up Shared Network Directory.................................................................................... 3-4 3.7 Secure Sensitive Configuration and Operational Data.......................................................... 3-4 3.8 Configure Identity in the IIS Application Pools..................................................................... 3-5 3.9 Reset IIS........................................................................................................................................ 3-5 4 Enable IIS HTTP Compression 4.1 IIS Web Page Compression....................................................................................................... 4-1 4.1.1 HTTP Compression............................................................................................................. 4-1 4.1.2 Known Effects of Enabling Compression........................................................................ 4-1 4.1.3 Enable HTTP Compression................................................................................................ 4-1 4.2 IIS Caching Settings.................................................................................................................... 4-2 4.2.1 IIS Caching............................................................................................................................ 4-2 4.2.2 Known Effects of Enabling Caching................................................................................. 4-2 4.2.3 Enable Caching..................................................................................................................... 4-2 4.3 Local Internet Explorer (IE) Client Caching Settings............................................................. 4-3 4.3.1 IE Client Caching................................................................................................................. 4-3 4.3.2 Enable IE Caching................................................................................................................ 4-3 4.3.3 IE Client Caching—Tab Options....................................................................................... 4-3 5 Install and Start Argus Safety Service 5.1 Install Argus Safety Service....................................................................................................... 5-1 5.2 Start Argus Safety Service.......................................................................................................... 5-2 5.3 Set Up RightFax........................................................................................................................... 5-2 6 Install and Configure Interchange 6.1 Prerequisites................................................................................................................................ 6-1 6.2 Install Interchange Service......................................................................................................... 6-1 6.3 Configure Interchange Service.................................................................................................. 6-2 6.4 Access EDI Gateway Shared Folders....................................................................................... 6-2 6.5 Configure Interchange Service .INI File.................................................................................. 6-2 7 Configure E-mail 7.1 Configure SMTP.......................................................................................................................... 7-1 8 Set Up the Client Browser 8.1 Prerequisites................................................................................................................................ 8-1 8.2 Install Files Required to View Japanese Text (For Japanese installation only).................. 8-1 8.3 Configure Internet Explorer...................................................................................................... 8-1 8.4 Add the Argus Site as a Local Intranet Site............................................................................. 8-2 8.5 Add Argus Site to the Enterprise Mode.................................................................................. 8-3 iv 8.6 Set Up Compatibility View with Internet Explorer............................................................... 8-3 8.7 Increase the Internet Explorer Timeout Setting to Run Reports.......................................... 8-3 9 Post-installation Checks 9.1 Post-Installation Tasks............................................................................................................... 9-1 9.1.1 General Checklist................................................................................................................. 9-1 9.1.2 Configure Argus Safety Windows Service to run as a Domain User.......................... 9-1 9.1.3 Configure Worklist Intake.................................................................................................. 9-2 9.1.3.1 RelsysWindowsService.exe.config............................................................................. 9-2 9.1.3.2 Service.config................................................................................................................ 9-3 9.1.3.3 Intake.config.................................................................................................................. 9-3 9.1.4 IIS Checklist.......................................................................................................................... 9-4 9.1.5 .INI File Checklist................................................................................................................ 9-4 9.1.6 Verify and Update Network Proxy Settings.................................................................... 9-4 9.2 Verify Files Installed on Middle Tier Servers......................................................................... 9-5 9.3 Verify Documentum Installation.............................................................................................. 9-5 9.3.1 Integrate Documentum Completely................................................................................. 9-6 9.3.2 Run Documentum on Argus Safety.................................................................................. 9-6 10 Other Tasks 10.1 Configure Argus.xml File....................................................................................................... 10-1 10.2 Configure Argus.ini File......................................................................................................... 10-1 10.2.1 Argus.ini Parameters........................................................................................................ 10-2 10.3 Install SSO on Oracle Access Manager 11g.......................................................................... 10-4 10.3.1 Prerequisites...................................................................................................................... 10-4 10.3.2 Install SSO.......................................................................................................................... 10-4 10.4 Installation Maintenance Tasks.............................................................................................. 10-5 10.4.1 Install New Components................................................................................................. 10-5 10.4.2 Uninstall Components..................................................................................................... 10-6 10.4.3 Remove All Components................................................................................................. 10-6 10.5 Set Up Printer Defaults........................................................................................................... 10-7 10.6 Argus Configuration Files...................................................................................................... 10-7 10.6.1 Backup Configuration Files............................................................................................. 10-7 Part III Install or Upgrade Argus Safety Database Tier 11 Install Argus Safety Database 11.1 Create Argus Safety Database Schema................................................................................. 11-1 11.1.1 Prepare to Install Schema Creation Tool....................................................................... 11-2 11.1.1.1 Prerequisites............................................................................................................... 11-2 11.1.1.2 Install Java.................................................................................................................. 11-2 11.1.1.3 Set Java Install Path................................................................................................... 11-2 11.1.1.4 Install XDB Schema for Interchange....................................................................... 11-3 11.1.2 Install the Schema Creation Tool.................................................................................... 11-3 11.1.3 Run Create DBA User Script........................................................................................... 11-3 11.1.4 Create Tablespaces (Optional)........................................................................................ 11-4 v 11.1.5 Prerequisites to Create the Schema................................................................................ 11-5 11.1.6 Configure the Database Setup Properties File.............................................................. 11-5 11.1.7 Create the Schema on Windows from the User Interface........................................... 11-7 11.1.8 Create the Schema on Windows from a Batch file....................................................... 11-9 11.1.9 Create the Schema on Linux or Unix............................................................................. 11-9 11.2 Post Fresh Install Steps............................................................................................................ 11-9 11.3 Oracle Text.............................................................................................................................. 11-10 11.4 Validate Argus Safety Database.......................................................................................... 11-10 11.4.1 Validate Argus Safety Database on Windows from a User Interface..................... 11-10 11.4.2 Validate Argus Safety Database on Windows from a Batch file.............................. 11-11 11.4.3 Validate Argus Safety Database on Linux or Unix.................................................... 11-11 11.5 Enable and Disable Data Lock Point (DLP)....................................................................... 11-11 11.5.1 Prerequisites.................................................................................................................... 11-12 11.5.2 Enable DLP...................................................................................................................... 11-12 11.5.3 Disable DLP..................................................................................................................... 11-12 11.6 Enable DLP on a Specific Enterprise................................................................................... 11-12 11.6.1 Set Up the Base Database............................................................................................... 11-13 11.6.2 Enable DLP on Specific Enterprise or Delta Cases.................................................... 11-13 11.6.3 Validate the Schema....................................................................................................... 11-14 11.7 Copy Configuration Data (Optional).................................................................................. 11-14 11.7.1 Set Up the Copy Configuration Tool........................................................................... 11-14 11.7.2 Use the Copy Configuration Tool................................................................................ 11-14 11.8 Create Argus Safety Read-only Database Account (Optional)....................................... 11-15 12 Upgrade Argus Safety Database 12.1 Prerequisites for Database Upgrade..................................................................................... 12-1 12.2 Argus Safety Database Upgrade............................................................................................ 12-1 12.3 Post Upgrade Steps.................................................................................................................. 12-2 12.4 Enable Local Locking in Argus Safety.................................................................................. 12-2 12.5 Merge a Single Enterprise Safety Database into a Multi-tenant Database...................... 12-3 12.5.1 Prerequisites to Run the Merge Export Step................................................................. 12-3 12.5.2 Merge Export..................................................................................................................... 12-3 12.5.3 Export the dmp File Copy to the Target Database Server.......................................... 12-4 12.5.4 Prerequisites to Run the Merge Import Step................................................................ 12-4 12.5.5 Merge Import.................................................................................................................... 12-5 12.5.6 Synchronize Dictionary Manually................................................................................. 12-6 13 Work with the Dictionaries 13.1 MedDRA Dictionary................................................................................................................ 13-1 13.1.1 Prerequisites...................................................................................................................... 13-1 13.1.2 Load MedDRA or MedDRA J Dictionary..................................................................... 13-2 13.1.3 Overwrite an Existing MedDRA or MedDRA J Dictionary....................................... 13-2 13.1.4 Recode MedDRA.............................................................................................................. 13-3 13.1.4.1 Run the Schema Creation Tool to Recode Events................................................. 13-4 13.2 WHO Drug Dictionary............................................................................................................ 13-5 13.2.1 Prerequisites...................................................................................................................... 13-5 13.2.2 Load WHO Drug Dictionary to New Tables................................................................ 13-6 vi 13.2.3 Overwrite an Existing WHO Drug Dictionary............................................................. 13-6 13.2.4 Load WHO Drug Dictionary Format C......................................................................... 13-7 13.3 J Drug Dictionary..................................................................................................................... 13-8 13.3.1 Prerequisites...................................................................................................................... 13-8 13.3.2 Create and Modify Required File .................................................................................. 13-8 13.3.2.1 Create All_Data.txt file............................................................................................. 13-9 13.3.2.2 Create formulationcode.txt file................................................................................ 13-9 13.3.2.3 Create drugnameenglish.txt file............................................................................ 13-10 13.3.2.4 Modify the.mdb file................................................................................................. 13-10 13.3.3 Load J Drug Dictionary.................................................................................................. 13-10 13.3.4 Overwrite an Existing J Drug Dictionary.................................................................... 13-11 Part IV Configure Other Products 14 Configure and Enable Argus Dossier 14.1 Prerequisites............................................................................................................................. 14-1 14.2 Configure Dossier.................................................................................................................... 14-1 14.3 Update IE Settings for Dossier............................................................................................... 14-2 14.4 Enable Dossier.......................................................................................................................... 14-2 15 Install and Configure Axway B2Bi 15.1 Create an Axway B2Bi Database Instance............................................................................ 15-1 15.2 Install Axway B2Bi................................................................................................................... 15-1 15.3 Configure Axway B2Bi............................................................................................................ 15-1 15.3.1 Configure Axway B2Bi for Binary File Transmission................................................. 15-3 15.3.2 Configure Axway B2Bi Community.............................................................................. 15-4 15.3.2.1 Register with the Axway B2Bi Community........................................................... 15-4 15.3.2.2 Add a Partner to the Axway B2Bi Community..................................................... 15-4 15.3.2.3 Register the Receiver's Community on the Sender Server.................................. 15-5 15.3.3 Add a Node....................................................................................................................... 15-5 15.3.4 Configure Axway B2Bi Certificates................................................................................ 15-6 15.3.4.1 Configure Receiver Axway B2Bi Certificates........................................................ 15-6 15.3.4.2 Configure Sender Axway B2Bi Certificates........................................................... 15-6 15.3.5 Configuring EVENTS.XML............................................................................................. 15-7 15.3.6 Configure Message Processing Settings........................................................................ 15-8 15.4 Test Communication............................................................................................................... 15-9 16 Install and Configure Oracle B2B 16.1 Install Oracle B2B..................................................................................................................... 16-1 16.2 Integrate Oracle B2B with Argus Safety............................................................................... 16-1 16.3 Create Integration tables in B2B Schema.............................................................................. 16-1 16.4 Configure Oracle B2B User Interface.................................................................................... 16-2 16.4.1 General Configuration > Administration > Configuration........................................ 16-2 16.4.2 Document Configuration > Administration > Document.......................................... 16-2 16.5 Configure Enterprise Manager.............................................................................................. 16-2 16.5.1 Deploy SOA Composite................................................................................................... 16-2 vii 16.5.2 Configure SOA Composite.............................................................................................. 16-3 16.5.2.1 AS_BPEL_Outbound Composite............................................................................ 16-3 16.5.2.2 AS_BPEL_Inbound Composite................................................................................ 16-3 16.6 Configure Web Logic Console............................................................................................... 16-3 16.6.1 Data source with JNDI Name as ’eis/DB/ArgusSafety_Outbound’........................ 16-4 16.6.2 Data source as ’jdbc/ArgusSafety_Inbound’............................................................... 16-4 16.6.3 Data source with JNDI Name as ’eis/DB/ArgusSafety_Inbound’........................... 16-4 16.6.4 DB Adapters for Data Source.......................................................................................... 16-4 16.7 Configure Large Payload Exchange...................................................................................... 16-4 16.7.1 Outbound Files.................................................................................................................. 16-5 16.7.2 Inbound Files..................................................................................................................... 16-5 16.7.3 Transaction Time.............................................................................................................. 16-5 16.7.4 General B2B Settings for Large Payloads...................................................................... 16-5 16.8 Configurations for Argus Safety............................................................................................ 16-5 16.8.1 Configure Oracle B2B....................................................................................................... 16-5 16.8.2 Update for B2B Documents............................................................................................. 16-5 16.8.3 Argus Console > Reporting Destination Code List..................................................... 16-6 17 Configure OBIEE or BI Publisher 17.1 Prepare BI Publisher Server.................................................................................................... 17-1 17.2 Set Up BI Publisher for Argus Safety.................................................................................... 17-1 17.2.1 Enable a Local Superuser................................................................................................. 17-1 17.2.2 Create a Database Connection........................................................................................ 17-2 17.2.3 Set Up Runtime BI Publisher Memory.......................................................................... 17-2 17.2.4 Configure Oracle Fusion Middleware Security Model............................................... 17-3 17.3 Manage Users and Roles......................................................................................................... 17-3 17.3.1 Configure Users, Groups and Roles............................................................................... 17-3 17.3.1.1 Create a Group........................................................................................................... 17-3 17.3.1.2 Create a User.............................................................................................................. 17-4 17.3.1.3 Create an Application Role...................................................................................... 17-4 17.3.2 Create Application Policies and Set Up Folder Privileges (BI Publisher Standalone only) 17-5 17.3.2.1 Create Application Policies...................................................................................... 17-5 17.3.2.2 Manage Folder Privileges......................................................................................... 17-6 17.3.3 Create Application Policies and Set Up Folder Privileges (OBIEE and BI Integrated Installation only) 17-8 17.3.3.1 Create Application Policies...................................................................................... 17-8 17.3.3.2 Manage Folder Privileges......................................................................................... 17-9 17.4 Upload BI Publisher Reports................................................................................................ 17-19 17.4.1 Flexible Aggregate Reports.......................................................................................... 17-19 17.4.2 PMDA R3 Paper Reports............................................................................................... 17-20 17.5 Integrate Argus Safety with BI Publisher........................................................................... 17-20 17.5.1 Configure AG Service.................................................................................................... 17-20 17.5.2 Configure Web Service (Expedited Reports only)..................................................... 17-21 17.5.3 Add AG Service user to BI Publisher (Expedited Reports only)............................. 17-21 17.5.4 Update SSO Exclusion List............................................................................................ 17-21 17.6 Argus Console—BIP Common Settings............................................................................. 17-22 viii 17.6.1 Configure BIP Reporting Admin User........................................................................ 17-22 17.6.2 Enable BIP Aggregate Reports and Configure Persistence Data (Flexible Aggregate Reporting only) 17-22 17.6.3 Configure Code Lists...................................................................................................... 17-23 17.6.3.1 Flexible Aggregate Reporting Code Lists............................................................ 17-23 17.6.3.2 PMDA R3 Paper Forms Code lists........................................................................ 17-23 17.7 Configure Flexible Aggregate Reporting Database.......................................................... 17-24 17.7.1 Execute Argus_BIP_Enable........................................................................................... 17-24 17.7.2 Database Jobs................................................................................................................... 17-25 17.7.2.1 Report Output Pusher............................................................................................. 17-25 17.7.2.2 Persist Data Cleaner................................................................................................ 17-25 17.8 Upgrade BIP Reports to 8.2.................................................................................................. 17-25 18 Install Argus Unblinding 18.1 Prerequisites............................................................................................................................. 18-1 18.2 Install Argus Unblinding Utility............................................................................................ 18-1 19 Configure Web Service Interfaces 19.1 Prerequisites............................................................................................................................. 19-1 19.2 Install Web Service Interfaces................................................................................................ 19-1 19.3 Reset IIS..................................................................................................................................... 19-2 19.4 Argus Web Service Interface.................................................................................................. 19-2 19.4.1 Argus Web Service Interface Framework..................................................................... 19-3 19.5 Edit .config Files....................................................................................................................... 19-3 19.5.1 Edit the .config file for Outbound Interfaces................................................................ 19-3 19.5.2 Edit the .config file for Inbound Interface..................................................................... 19-4 19.6 Safety Message ........................................................................................................................ 19-4 19.7 MedDRA Interface................................................................................................................... 19-4 19.7.1 MedDRA Configuration.................................................................................................. 19-5 19.7.1.1 Enable MedDRA Integration through Argus Console......................................... 19-5 19.7.1.2 Edit the ArgusWeb/ASP/web.config file............................................................. 19-5 19.7.1.3 Edit the Argus.NET/web.config file...................................................................... 19-5 19.7.2 MedDRA Encoding Flow................................................................................................ 19-6 19.7.3 Examples of MedDRA Encoding Safety Message........................................................ 19-6 19.7.3.1 Request (V 2.0)........................................................................................................... 19-6 19.7.3.2 Response (V2.0).......................................................................................................... 19-7 19.7.3.3 Request (V 1.1)........................................................................................................... 19-8 19.7.3.4 Response (V 1.1)......................................................................................................... 19-9 19.7.3.5 Request (V 1.0)......................................................................................................... 19-10 19.7.3.6 Response (V 1.0)....................................................................................................... 19-11 19.7.4 MedDRA Interface XML Schema................................................................................. 19-12 19.7.4.1 MEDDRA_Request.................................................................................................. 19-12 19.7.4.2 MEDDRA_Response............................................................................................... 19-13 19.8 Product Study License Interface.......................................................................................... 19-14 19.9 WHO Drug Coding Interface............................................................................................... 19-15 19.9.1 Configuration.................................................................................................................. 19-16 ix 19.9.2 Drug Dictionary Coding Flow...................................................................................... 19-16 19.9.3 Example of WHO Drug Coding Safety Message....................................................... 19-16 19.9.3.1 Request...................................................................................................................... 19-16 19.9.3.2 Response................................................................................................................... 19-17 19.9.4 WHO Drug Coding: XML Schema............................................................................... 19-19 19.9.4.1 Request: WHODrug_Request................................................................................ 19-19 19.9.4.2 Response: WHODrug_Response........................................................................... 19-19 19.10 Lot Number Interface............................................................................................................ 19-20 19.10.1 Configuration.................................................................................................................. 19-20 19.10.2 Lot Validation Flow........................................................................................................ 19-21 19.10.3 Example of Lot Number Safety Message.................................................................... 19-21 19.10.3.1 Request...................................................................................................................... 19-21 19.10.3.2 Response................................................................................................................... 19-22 19.10.4 Lot Number: XML Schema............................................................................................ 19-23 19.10.4.1 Request: Lot_Request.............................................................................................. 19-23 19.10.4.2 Response: Lot_Response......................................................................................... 19-24 19.10.5 Transformation................................................................................................................ 19-24 19.11 Worklist Intake....................................................................................................................... 19-25 19.11.1 Configuration.................................................................................................................. 19-25 19.11.2 Worklist Intake Flow...................................................................................................... 19-26 19.11.3 Example of Worklist Intake Safety Message............................................................... 19-27 19.12 Literature Intake..................................................................................................................... 19-29 19.12.1 Configuration.................................................................................................................. 19-29 19.12.1.1 Metadata Configuration......................................................................................... 19-30 19.12.2 Literature Intake Flow.................................................................................................... 19-31 19.13 Extended E2B Interface......................................................................................................... 19-31 20 Configure Argus Centralized Coding 20.1 setup_centralized_coding_interface_schema.bat................................................................ 20-1 20.2 dms_migration.bat................................................................................................................... 20-2 20.2.1 Single Enterprise Migration in One Execution............................................................. 20-2 20.2.2 All Enterprise Migration in One Execution.................................................................. 20-2 Part V Secure Argus Safety 21 Argus Password Management—Cryptography Tool 21.1 Install or Upgrade to Argus Safety 8.2.................................................................................. 21-1 21.1.1 Generate New Cryptography Key................................................................................. 21-1 21.1.2 Argus Safety Database..................................................................................................... 21-2 21.1.3 Argus Safety Application Servers.................................................................................. 21-2 21.2 Reset Password or Change the Cryptography Key............................................................ 21-2 21.2.1 Reset the ARGUSUSER Password................................................................................. 21-2 21.2.2 Edit Keys............................................................................................................................ 21-3 21.2.3 Re-encrypt Common User Passwords........................................................................... 21-4 21.2.4 Generate Encrypted String.............................................................................................. 21-5 21.2.5 Reset Administrator and System Application User Password.................................. 21-5 x