Contents

List of Figures

List of Tables

Title and Copyright Information

Preface

• Audience
• Documentation Accessibility
• Finding Information and Patches on My Oracle Support
• Finding Oracle Documentation
• Related Documents
• Conventions

1 Preparing to Install Oracle Clinical

• 1.1 Oracle Clinical Architecture
• 1.2 Oracle Clinical and RDC 4.6.2 Technology Stack
• 1.3 Product Organization, Licenses, and Related Install Documentation
• 1.4 Choosing a Character Set
• 1.5 Downloading the Media Pack
• 1.6 Planning an Oracle Clinical Database Tier Installation
  • 1.6.1 Database Tier Operating System Requirements
  • 1.6.2 Database Tier Character Set Requirements
  • 1.6.3 Database Tier System Requirements
    • 1.6.3.1 C Run-time Libraries on UNIX Database Servers
  • 1.6.4 Oracle Database 11g Release 2 (11.2.0.2) Patch Set 1 Requirements and Options
    • 1.6.4.1 Required Reading
    • 1.6.4.2 Oracle Text Option
    • 1.6.4.3 Oracle Database 11g Release 2 (11.2.0.2) Patch Set 1 Partitioning Option
    • 1.6.4.4 Oracle Distributed Study Conduct Option
  • 1.6.5 Global Library Location
  • 1.6.6 Database Seed Numbers in a Replicated Environment
• 1.7 Planning an Oracle Clinical Application Tier Installation
  • 1.7.1 Application Tier Operating System Requirements
  • 1.7.2 Application Tier Character Set Requirements
  • 1.7.3 Forms Server Requirements
    • 1.7.3.1 Critical Patch Update
    • 1.7.3.2 Permanent IP Address
    • 1.7.3.3 Oracle Application Servers
    • 1.7.3.4 Java Runtime Environment
    • 1.7.3.5 Shared Directory on Application Server
    • 1.7.3.6 Planning File Viewing and Associated Directories
  • 1.7.4 Reports Server Requirements
    • 1.7.4.1 Critical Patch Update
    • 1.7.4.2 Permanent IP Address
    • 1.7.4.3 Oracle Application Servers
    • 1.7.4.4 Load Tuning Reports Servers
• 1.8 Planning an Oracle Clinical Client Installation
  • 1.8.1 Client Tier Operating System Requirements
  • 1.8.2 Client Tier Application Requirements
• 1.9 Integrating Oracle Clinical with Other Products and Options
  • 1.9.1 Oracle Remote Data Capture
  • 1.9.2 Oracle Thesaurus Management System
  • 1.9.3 Siebel Clinical
  • 1.9.4 SAS 9.2 Software
  • 1.9.5 Custom Applications for Oracle Clinical
• 1.10 Applying Oracle Critical Patch Updates
• 1.11 Applying the Latest Oracle Clinical Patch Set
• 1.12 Following the Installation Constraints and Order
• 1.13 Reviewing the Installation Log Files

2 Installing Oracle Clinical Database Server on UNIX

• 2.1 Performing Prerequisite Tasks for Installing Oracle Database 11g Release 2 (11.2.0.2) Patch Set 1
  • 2.1.1 Create Owners, Groups, and Mount Points
  • 2.1.2 Configure Kernel Resources and Adjust Operating System Environment
  • 2.1.3 Test the C Compiler Installation
  • 2.1.4 Install Latest Operating System Patches
• 2.2 Installing Oracle Database 11g Release 2 (11.2.0.2) Patch Set 1
  • 2.2.1 Install Oracle Database 11g Release 2 (11.2.0.2) Patch Set 1
  • 2.2.2 Install Oracle Database 11g Release 2 (11.2.0.2) Patch Set 1 Examples
  • 2.2.3 Install Patch 10213073 to Oracle Database 11g Release 2 (11.2.0.2) Patch Set 1
  • 2.2.4 Install CPU/PSU 10248523
• 2.3 Setting Permissions and Write Access to Oracle-Owned Directories
  • 2.3.1 Change Permissions for Running oraenv Script
  • 2.3.2 Grant Access to the ORACLE_HOME Directory
  • 2.3.3 Set Permissions for the Oracle Inventory Directory
• 2.4 Setting Up User Groups and Accounts
  • 2.4.1 Create the oclsascr User Group for SAS
  • 2.4.2 Create the opapps Account
  • 2.4.3 Create the rxcprod Account
• 2.5 Installing the Oracle Clinical Database Server
  • 2.5.1 Oracle Clinical Database Server Directory Structure for UNIX
  • 2.5.2 Transfer the Oracle Clinical Database Server Software
  • 2.5.3 Start Installing the Database Server Software
  • 2.5.4 Attend to the Oracle Clinical Database Server Installation Screens
  • 2.5.5 Review the Installation Log Files
  • 2.5.6 Remove Group Privileges from this Session
• 2.6 Performing Post-installation Tasks
  • 2.6.1 Complete the Setup of the opapps Account
  • 2.6.2 Complete the Setup of the rxcprod Account
  • 2.6.3 Review the opa_settings File
  • 2.6.4 Apply the Latest Critical Patch Updates and Any New Patches

3 Installing the Oracle Clinical Database Server on Windows

• 3.1 Installing and Patching Oracle Database 11g Release 2 (11.2.0.2) Patch Set 1
  • 3.1.1 Install Oracle Database 11g Release 2 (11.2.0.2) Patch Set 1
  • 3.1.2 Install Oracle Database 11g Release 2 (11.2.0.2) Patch Set 1 Examples
  • 3.1.3 Apply Patch Bundle 12767726
• 3.2 Setting Up User Accounts and User Groups
  • 3.2.1 Create the RXCPROD Account
  • 3.2.2 Create the oclsascr User Group
  • 3.2.3 Setting Up Local Policy Security Options
• 3.3 Installing the Oracle Clinical 4.6.2 Database Server
  • 3.3.1 Oracle Clinical 4.6.2 Database Server Directory Structure for Windows
  • 3.3.2 Start the Oracle Clinical 4.6.2 Database Server Installation for Windows
  • 3.3.3 Attend to the Oracle Clinical 4.6.2 Database Server Installation Screens
• 3.4 Performing Post-installation Tasks
  • 3.4.1 Limit Permissions on the XMLTEMP Folder
  • 3.4.2 Create the PSUB Root Directory for File Viewing
  • 3.4.3 Edit the opa_settings.bat File
  • 3.4.4 Apply the Latest CPU Security Update and Any New Patch Sets and Patches

4 Creating an Oracle Clinical Database

• 4.1 Reviewing Database Requirements and Recommendations
  • 4.1.1 Start with a New Database Instance
  • 4.1.2 Decide on Lowercase or Uppercase SID Name for UNIX
  • 4.1.3 Check Required Tablespaces
  • 4.1.4 Use the Database Configuration Assistant
  • 4.1.5 Select Required Components
  • 4.1.6 Use Automatic Memory Management
  • 4.1.7 Review Entries in the opa_settings File
  • 4.1.8 Set Initialization Parameters
  • 4.1.9 Modify the tnsnames.ora File
• 4.2 Installing Oracle Clinical Database Objects
  • 4.2.1 Transfer the Oracle Clinical UNIX Media
  • 4.2.2 Customize the Installation
    • 4.2.2.1 Edit the Tablespace Size Scripts
    • 4.2.2.2 Edit the User Account Creation Script
  • 4.2.3 Start Installing the Oracle Clinical Database
    • 4.2.3.1 Start the Installer on a UNIX Server
    • 4.2.3.2 Start the Installer on a Windows Server
  • 4.2.4 Attend to the Oracle Clinical Database Installation Screens
  • 4.2.5 Remove Group Privileges from this Session (UNIX Only)
• 4.3 Reviewing the Log Files for Installation Errors
• 4.4 Performing Post-Installation Database Tasks
  • 4.4.1 Change Default Passwords for Schemas and Roles
  • 4.4.2 Enroll Users
  • 4.4.3 Set the Database Time Zone
  • 4.4.4 Pin Database Packages
    • 4.4.4.1 Pin UNIX Database Packages
    • 4.4.4.2 Pin Windows Database Packages
  • 4.4.5 Check Disconnected Replication Tablespace
  • 4.4.6 Review Optimization Statistics
  • 4.4.7 Consider Implementing Partitioning

5 Installing and Configuring Oracle Application Server

• 5.1 Installing the Oracle Application Server Technology Stack
  • 5.1.1 Set the Windows Compatibility Mode for the setup.exe File
  • 5.1.2 Install Oracle Application Server 10g Release 2 (10.1.2.0.2)
    • 5.1.2.1 Attend to the Oracle Application Server 10g Release 2 Installation Screens
    • 5.1.2.2 Apply Oracle Oracle Application Server 10g Release 2 Patch Set 3 (10.1.2.3.0)
    • 5.1.2.3 Restart the Computer
  • 5.1.3 Install Oracle Application Server 10g Release 3 (10.1.3.1.0)
    • 5.1.3.1 Attend to the Oracle Application Server 10g Release 3 Installation Screens
    • 5.1.3.2 Apply Oracle Application Server 10g Release 3 Patch Set 5 (10.1.3.5.0)
    • 5.1.3.3 Configure the Oracle AS10gR3 Process Manager
    • 5.1.3.4 Restart the Computer
• 5.2 Setting Up Oracle Application Server 10g Release 3 for SSL
• 5.3 Modifying the Oracle Process Manager Service
• 5.4 Applying Critical Patch Updates
• 5.5 Setting Up the SQL*Net Connections for Existing Databases
  • 5.5.1 Test the Connection from the Application Servers to the Database
  • 5.5.2 Troubleshoot Network Connection Issues
• 5.6 Installing Printers on the Application Tier

6 Installing Oracle Clinical Front End

• 6.1 Installing the Oracle Clinical Front End Components
  • 6.1.1 Attend to the Oracle Clinical Front End Installation Screens
  • 6.1.2 Review the Installation Log File
  • 6.1.3 Restart the Computer
  • 6.1.4 Update the Mandatory System Registry Values for Oracle Clinical Front End
• 6.2 Making the Java Runtime Environment Available for Download
• 6.3 Downloading the Oracle Clinical PDF Plug-in
• 6.4 Changing the Password for the opaconfig User
• 6.5 Sharing the RDC Directory and Setting Image Browsing
• 6.6 Installing and Configuring the JSpell Spell Checker SDK
  • 6.6.1 Download and Install JSpell
  • 6.6.2 Install the JSpell WAR File on Application Server 10gR3
  • 6.6.3 Test the JSpell Servlet
  • 6.6.4 Change the Lexicons Directory
  • 6.6.5 Update the formsweb.cfg File for JSpell
  • 6.6.6 Update the Windows System Registry for JSpell
• 6.7 Applying Forms Server Customizations
  • 6.7.1 Upgrade the User Menu
  • 6.7.2 Upgrade rxclbcli.pll
  • 6.7.3 Change DE_GRIDWIDTH and DE_GRIDHEIGHT Parameters

7 Installing Reports Servers

• 7.1 Types of Reports Server Installations
• 7.2 Installing the Oracle Clinical Reports Server
  • 7.2.1 Attend to the Oracle Clinical Reports Server Installation Screens
  • 7.2.2 Review the Installation Log File
  • 7.2.3 Restart the Computer
• 7.3 Setting Up the Reports Server for Access and File Viewing
  • 7.3.1 Create the Reports Server Root Directory
  • 7.3.2 Share and Grant Access to the Reports Server Root Directory
  • 7.3.3 Create Reports Server Log Directories for Each User
  • 7.3.4 Specify Directory Mappings for PSUB in Each Database
  • 7.3.5 Configure the Reports Server for DCI Forms and PDRs
• 7.4 Adding the Reports Server to the Database Reference Codelist
• 7.5 Replacing the Placeholder DCF Logo Graphic
• 7.6 Customizing and Upgrading DCF Reports
• 7.7 Testing the Reports Server Installation
• 7.8 Troubleshooting Reports Server Problems

8 Setting Up the Parameterized Submission Process

• 8.1 PSUB Uses Secure Shell (UNIX Only)
• 8.2 Setting Up Secure Shell for the rxcprod User (UNIX Only)
• 8.3 Setting Up Oracle Clinical PSUB Users (UNIX Only)
• 8.4 Testing the Secure Shell Setup (UNIX Only)
  • 8.4.1 Validate Use of Public/Private Key Authentication
  • 8.4.2 Verify the Fingerprint of the Public Key
• 8.5 Configuring for the at Command (UNIX Only)
• 8.6 Starting and Testing the PSUB Process
  • 8.6.1 Starting the PSUB Process on UNIX
  • 8.6.2 Changing the Startup Type of the PSUB Service on Windows
  • 8.6.3 Configuring Windows Registry Setting for PSUB (Windows Only)
  • 8.6.4 Starting the PSUB Service on Windows
  • 8.6.5 Test the PSUB Installation
    • 8.6.5.1 Home Permissions and Secure Shell (UNIX Only)
    • 8.6.5.2 Settings for the UTF8 Character Set and the PSUB Process
• 8.7 Customizing the PSUB Process

9 Implementing Secure FTP for File Viewing (UNIX Only)

• 9.1 About Secure FTP and Oracle Clinical
• 9.2 Obtaining and Installing SFTP Software
• 9.3 Setting Up SFTP
  • 9.3.1 Generate and Configure the Private/Public Key Pair
  • 9.3.2 Create the restricted_sftp.sh File
  • 9.3.3 Modify Accounts to Use SFTP
• 9.4 Testing that Password Prompt Is Bypassed
• 9.5 Setting the Oracle Entries in the System Registry for SFTP
  • 9.5.1 Modifying PSUB_FTP_SECURE and PSUB_FTP_COMMAND
  • 9.5.2 Ensuring Files Transfer in ASCII Mode with WinSCP
  • 9.5.3 Switching Between SFTP and FTP File Viewing Post-Installation
• 9.6 Testing SFTP for File Viewing
• 9.7 Viewing New Lines in PSUB Files

10 Setting Up Clients

• 10.1 About an Oracle Clinical Client Installation
  • 10.1.1 Operating System Requirements for Oracle Clinical and RDC Clients
  • 10.1.2 Application Requirements for Oracle Clinical and RDC Clients
• 10.2 Configuring Personal Firewall
• 10.3 Setting Internet Options for Microsoft Internet Explorer
  • 10.3.1 Set Up for Proxy Usage on Fully Qualified Application Tier Names
  • 10.3.2 Set Internet Explorer Modes
  • 10.3.3 Using Internet Explorer 8 or 9 with RDC Onsite
• 10.4 Starting and Logging In to Oracle Clinical
• 10.5 Downloading Required Applications for Clients
  • 10.5.1 Download the Java Runtime Environment
  • 10.5.2 Download the Oracle Clinical PDF Plug-in
  • 10.5.3 Download Adobe Reader
• 10.6 Mapping Network Drive for Image Browsing
• 10.7 Enabling Report Generation from the Command Line

11 Setting Up SAS

• 11.1 Modifying SAS 9.2 and opa_settings on UNIX
  • 11.1.1 Prepare the SAS Template File
  • 11.1.2 Edit the opa_settings File
  • 11.1.3 Additional Modifications for Oracle Solaris
• 11.2 Installing SAS on the Same UNIX Computer as Oracle Clinical
  • 11.2.1 Set REMOTE_OS_AUTHENT to FALSE
  • 11.2.2 Edit the opa_setup Script
• 11.3 Installing SAS on a Different UNIX Computer from Oracle Clinical
  • 11.3.1 Establish the Connection to SAS
  • 11.3.2 Configuring Private and Public Keys for Using SSH with SAS
• 11.4 Modifying SAS 9.2 for Windows
• 11.5 Installing SAS on the Same Windows Server Computer
  • 11.5.1 Set REMOTE_OS_AUTHENT to FALSE
  • 11.5.2 Set System Path
  • 11.5.3 Edit the SAS Config File and Grant Permissions
• 11.6 Installing SAS on a Different Windows Server Computer
  • 11.6.1 Set REMOTE_OS_AUTHENT to TRUE
  • 11.6.2 Enable Executing Data Extract PSUB Jobs
  • 11.6.3 Edit the SAS Config File and Grant Permissions

12 Upgrading an Oracle Clinical Installation to Release 4.6.2

• 12.1 Determining Whether You Need to Prepare and Migrate Data
  • 12.1.1 Methods to Identify If Scripts Were Already Run
• 12.2 Completing Other Pre-Upgrade Tasks
  • 12.2.1 Back Up Your Database(s)
  • 12.2.2 Stop Replication
    • 12.2.2.1 Preparing All Replication Environments
    • 12.2.2.2 Stopping Standard Replication
    • 12.2.2.3 Stopping Symmetric Replication
  • 12.2.3 Prevent Access to Oracle Clinical Databases
  • 12.2.4 Stop PSUB
• 12.3 Create a New Oracle Database 11g Release 2 (11.2.0.2) Patch Set 1 Oracle Home
  • 12.3.1 Creating a New UNIX Oracle Database 11g Release 2 (11.2.0.2) Patch Set 1 Oracle Home
  • 12.3.2 Creating a New Windows Oracle Database 11g Release 2 (11.2.0.2) Patch Set 1 Oracle Home
• 12.4 Installing Oracle Clinical 4.6.2 on the Database Server
  • 12.4.1 Install Oracle Clinical 4.6.2 on a UNIX Database Server
    • 12.4.1.1 Installing the UNIX Oracle Clinical Database Server Component
    • 12.4.1.2 Modifying the Default Environment Variable Settings
  • 12.4.2 Install Oracle Clinical 4.6.2 on a Windows Database Server
• 12.5 Upgrading Oracle Clinical to the New Oracle 11gR2 Home
  • 12.5.1 Review Options Before Upgrading the Database
    • 12.5.1.1 About Partitioning
    • 12.5.1.2 Legacy Installations
  • 12.5.2 Review Tablespace Sizes
    • 12.5.2.1 Tablespace Sizes When Upgrading from Oracle Clinical 4.5.1
    • 12.5.2.2 Tablespace Sizes When Upgrading from Oracle Clinical 4.5.2 or 4.5.3
  • 12.5.3 Upgrade the 9.2.0.8 or 11.1.0.7 Oracle Clinical Database to the 11.2.0.2.0 Oracle Home
• 12.6 Upgrading Database Objects to Oracle Clinical 4.6.2
  • 12.6.1 Windows Installer Starting Instructions
  • 12.6.2 UNIX Installer Starting Instructions
  • 12.6.3 Attend to the Oracle Clinical Database Upgrade Installation Screens
  • 12.6.4 Remove Group Privileges from this Session
  • 12.6.5 Review the Log Files for Upgrade Results and Errors
    • 12.6.5.1 Known Error Messages
    • 12.6.5.2 Reencrypting Account Passwords
    • 12.6.5.3 Finding Errors
  • 12.6.6 Compile Invalid Objects
    • 12.6.6.1 Compiling PL/SQL Code Before Running the Script
    • 12.6.6.2 Running the compile_schema_invalid.sql Script
  • 12.6.7 Check the EVENT Parameter in the init.ora File
  • 12.6.8 Perform Post-Upgrade Database Tasks
    • 12.6.8.1 Set Initialization Parameters
    • 12.6.8.2 Change Default Passwords for Schemas and Roles
    • 12.6.8.3 Enroll Users
    • 12.6.8.4 Pin Database Packages
    • 12.6.8.5 Analyze Tables and Review Optimization Statistics
• 12.7 Installing and Configuring Other Components
• 12.8 Preserving Customizations
• 12.9 Repairing Oracle Clinical Data
  • 12.9.1 Repairing Oracle Clinical 4.5.3 Data
  • 12.9.2 Repairing Release 4.5.1 Data
• 12.10 Preparing and Migrating Data If Necessary
• 12.11 Starting the PSUB Process
  • 12.11.1 Starting the PSUB Process on UNIX
  • 12.11.2 Changing the Startup Type of the PSUB Service on Windows
  • 12.11.3 Starting the PSUB Service on Windows
  • 12.11.4 Troubleshooting PSUB on a Windows Database
• 12.12 Upgrading Installations that Use Replication
  • 12.12.1 Re-enable Replication
  • 12.12.2 Replicate Approval and Verification Tracking Records
  • 12.12.3 Replicate Page Tracking, Discrepancies, and DCFs
    • 12.12.3.1 Option 1: Do a Full Replication Following the Upgrade
    • 12.12.3.2 Option 2: Do an Incremental Replication and Run a Script
• 12.13 Applying the Latest Patch Set

A Migrating Data for Approvals and Verifications Enhancements

• A.1 Determining Requirements Before Preparing and Migrating Data
  • A.1.1 Benchmarks for Estimating Downtime Required to Prepare and Migrate Data
  • A.1.2 Tablespace Size Requirements
• A.2 Before You Prepare and Migrate Data
  • A.2.1 Back Up the Databases Before Preparing and Migrating Data
  • A.2.2 Prevent Access to Oracle Clinical Databases
• A.3 Preparing Your Data for Migration
  • A.3.1 About the Preparation Script
  • A.3.2 Set Up for the Preparation Script
    • A.3.2.1 Setting Up for the Preparation Script in UNIX
    • A.3.2.2 Setting Up for the Preparation Script in Windows
  • A.3.3 Run the Preparation Script
  • A.3.4 Check the Progress of the Preparation Script
  • A.3.5 View the Output File Created by the Preparation Script
• A.4 Migrating Your Data
  • A.4.1 About the Data Migration Script
  • A.4.2 Set Up the Environment Before Migrating Data
    • A.4.2.1 Setting Up for the Data Migration Script in UNIX
    • A.4.2.2 Setting Up for the Data Migration Script in Windows
  • A.4.3 Run the Data Migration Script
  • A.4.4 Check the Progress of the Data Migration Script
  • A.4.5 View the Output File Created by the Data Migration Script
  • A.4.6 Replicate Approval and Verification Tracking Records
    • A.4.6.1 Determining If You Need to Run the oclupg45311replicate.sql Script
    • A.4.6.2 Running the oclupg45311replicate.sql Script
• A.5 Migrating a Single Study Before Unfreezing It
  • A.5.1 Setting Up for the Data Migration Script in UNIX
  • A.5.2 Setting Up for the Data Migration Script in Windows
  • A.5.3 Migrating a Nonmigrated Frozen Study

Index