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Oracle® Clinical Installation Guide
Release 4.6.2
E18817-04
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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 11
g
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 11
g
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 11
g
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 11
g
Release 2 (11.2.0.2) Patch Set 1
2.2.1
Install Oracle Database 11
g
Release 2 (11.2.0.2) Patch Set 1
2.2.2
Install Oracle Database 11
g
Release 2 (11.2.0.2) Patch Set 1 Examples
2.2.3
Install Patch 10213073 to Oracle Database 11
g
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 11
g
Release 2 (11.2.0.2) Patch Set 1
3.1.1
Install Oracle Database 11
g
Release 2 (11.2.0.2) Patch Set 1
3.1.2
Install Oracle Database 11
g
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 10
g
Release 2 (10.1.2.0.2)
5.1.2.1
Attend to the Oracle Application Server 10
g
Release 2 Installation Screens
5.1.2.2
Apply Oracle Oracle Application Server 10
g
Release 2 Patch Set 3 (10.1.2.3.0)
5.1.2.3
Restart the Computer
5.1.3
Install Oracle Application Server 10
g
Release 3 (10.1.3.1.0)
5.1.3.1
Attend to the Oracle Application Server 10
g
Release 3 Installation Screens
5.1.3.2
Apply Oracle Application Server 10
g
Release 3 Patch Set 5 (10.1.3.5.0)
5.1.3.3
Configure the Oracle AS10
g
R3 Process Manager
5.1.3.4
Restart the Computer
5.2
Setting Up Oracle Application Server 10
g
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 10
g
R3
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 11
g
Release 2 (11.2.0.2) Patch Set 1 Oracle Home
12.3.1
Creating a New UNIX Oracle Database 11
g
Release 2 (11.2.0.2) Patch Set 1 Oracle Home
12.3.2
Creating a New Windows Oracle Database 11
g
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 11
g
R2 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