Contents

List of Examples

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 Getting Started with Administration Tasks

• 1.1 About Administrator Privileges for Maintaining RDC Onsite
  • 1.1.1 About Database Roles for RDC Onsite Users
  • 1.1.2 About User Roles with Limited Administrator Privileges
• 1.2 Starting the RDC Administration Application
  • 1.2.1 RDC Administration Main Window
  • 1.2.2 About Maintain Mode versus Query Mode
  • 1.2.3 About the Searches Option
• 1.3 Starting the Oracle Clinical Application
• 1.4 Modifying Files on the Application Server
• 1.5 Stopping and Restarting the rdc OC4J Instance

2 Securing RDC Onsite

• 2.1 About Security Privileges
  • 2.1.1 Minimum Requirement for Privileges
  • 2.1.2 Privileges and Batch-Loaded CRFs
  • 2.1.3 Site Privileges Take Precedence Over Study Privileges
• 2.2 Assigning Study and Site Security Privileges
  • 2.2.1 Opening the Security Privileges Forms
  • 2.2.2 Configuring Study and Site Security Privileges
  • 2.2.3 Granting Administrator Privileges to Individual Users
• 2.3 Granting Oracle Clinical Users Access to RDC Onsite
• 2.4 Managing Security with Data Entry Configuration Settings
  • 2.4.1 Changing the Data Entry Configuration Settings
  • 2.4.2 Authority to Resolve Discrepancies upon Discrepancy Creation
  • 2.4.3 Authority to Update Locked CRFs and Override Repeating Defaults
  • 2.4.4 Modifying Data Entry Configurations at the Database, Study, and User Levels
    • 2.4.4.1 At the Local Database Level
    • 2.4.4.2 At the Study Level or the User Level
• 2.5 Restricting Actions Against Locked CRFs
• 2.6 Restricting Access to Data Collection Instruments (DCIs)
  • 2.6.1 Changing the Default Access to DCIs
  • 2.6.2 Defining DCI Access within a Study
    • 2.6.2.1 Opening the Maintain Access to DCIs within Study Form
    • 2.6.2.2 Defining Inclusions and Exclusions for DCI Access
• 2.7 Creating Password-Protected Roles and Encrypting Passwords

3 Customizing with RDC Configurations

• 3.1 About the RDC Configurations
  • 3.1.1 Default Configurations
  • 3.1.2 Assignment Parameters
    • 3.1.2.1 Default Value (%) for Assignment Parameters
    • 3.1.2.2 Assigning Configurations
    • 3.1.2.3 Precedence and Parsing of Assignment Parameters
• 3.2 Managing RDC Configurations
  • 3.2.1 Opening and Using the RDC Configurations Form
  • 3.2.2 Creating a New Configuration
  • 3.2.3 Specifying the Settings for a Configuration
  • 3.2.4 Assigning Configurations to Users
    • 3.2.4.1 Modifying the Existing Assignments for a Configuration
    • 3.2.4.2 Creating New Assignments for an Existing Configuration
  • 3.2.5 Deleting Assignments and Configurations
  • 3.2.6 RDC Configurations in the Oracle Clinical Reference Local Codelists
• 3.3 Configuration Settings for RDC Onsite
  • 3.3.1 Customizing the Label for the Links Section on the Home Page
  • 3.3.2 Hiding the Preferences Links
  • 3.3.3 Displaying Time Stamps in Local Time
  • 3.3.4 Allowing Group Verifications and Approvals
  • 3.3.5 Using the Oracle Clinical Accessibility Rules
  • 3.3.6 Disabling the Save Complete Prompt
  • 3.3.7 Specifying a Default Highlighting Scheme for the Data Entry Window
  • 3.3.8 Allowing Access to CRFs Entered via Oracle Clinical or RDC Classic
  • 3.3.9 Suppressing the Validation Error Alert

4 Configuring Discrepancy Management

• 4.1 Tools for Configuring Discrepancy Management
• 4.2 Defining the Reasons for Discrepancies
  • 4.2.1 Defining the Reasons for Manual Discrepancies
  • 4.2.2 Defining the Reasons for Univariate Discrepancies
  • 4.2.3 Defining the Reasons for Multivariate Discrepancies
• 4.3 Defining the Review Statuses for Discrepancies
  • 4.3.1 Default Entries for the DISCREPANCY REV STATUS CODE Codelist
  • 4.3.2 Rules for the DISCREPANCY REV STATUS CODE Codelist
• 4.4 Configuring the Access Statuses for Discrepancies
  • 4.4.1 Access Status Values
  • 4.4.2 Colors Used to Indicate Discrepancy Access Status
  • 4.4.3 Default Entries for the DISCREPANCY STATUS role Codelists
  • 4.4.4 Rules for the DISCREPANCY STATUS role Codelist
• 4.5 Configuring the Actions Allowed against Discrepancies
  • 4.5.1 Default Entries for the DISCREPANCY ACTIONS role Codelists
  • 4.5.2 Rules for the DISCREPANCY ACTIONS role Codelist
• 4.6 Defining the Resolution Reasons for Discrepancies
• 4.7 Preventing Update to OTHER Discrepancies

5 Customizing Data Entry Behavior

• 5.1 Configuring the DCI Form Runtime Settings
  • 5.1.1 Defining the DCI Form Runtime Settings at the Database Level
  • 5.1.2 Defining Report Settings at the Study Level
  • 5.1.3 Enabling HTML Data Entry for RDC Onsite
  • 5.1.4 Displaying the Visit-Owning Interval on the Casebooks Page
  • 5.1.5 Allowing Investigator Comments
  • 5.1.6 Adding a Customized Reference Field to the Search Pane
    • 5.1.6.1 Searching and Viewing Enhancements for the Customized Field
    • 5.1.6.2 Labeling and Enabling Your Customized Search Field
    • 5.1.6.3 Writing the Derivation Procedure to Use Your Customized Field
  • 5.1.7 Controlling the Display of Conditional Blocks within a CRF
  • 5.1.8 Suppressing Prompts and Warnings
    • 5.1.8.1 Suppressing the Change Reason Prompt for New Responses
    • 5.1.8.2 Suppressing the Change Reason Prompt for Investigator Comments
    • 5.1.8.3 Suppressing the Warning for Non-migrated CRFs
• 5.2 Using DCI Book Assignment
  • 5.2.1 Manually Assigning Patients to DCI Books Using Oracle Clinical
  • 5.2.2 Automatically Assigning the DCI Book upon Initial Data Entry
  • 5.2.3 Allowing Patient Book Assignments to Change
• 5.3 Specifying CRFs for Single Use
• 5.4 Customizing the Display of a List of Values
• 5.5 Defining the List of Allowable Change Reasons
  • 5.5.1 Accessing the Codelists to Customize the Change Reason Values
    • 5.5.1.1 Reserved Change Reason Values
    • 5.5.1.2 Identifying the Default Change Reason
    • 5.5.1.3 Identifying Change Reasons NOT for Use in RDC Onsite
  • 5.5.2 Suppressing the Reason for Change Dialog Box
• 5.6 Setting the Format of Dates
  • 5.6.1 Setting Date Formats at the Database Level
  • 5.6.2 Setting Date Formats for Individual Users

6 Customizing RDC Onsite on the Application Server

• 6.1 Creating a Launch Page for RDC Onsite
  • 6.1.1 Setting Up A Link to Launch RDC Onsite
    • 6.1.1.1 Sample JavaScript for Creating a Link to RDC Onsite
    • 6.1.1.2 Sample HTML for Creating a Button or Link to RDC Onsite
  • 6.1.2 Customizing the RDC Onsite URL
• 6.2 Customizing the Reset Password Link
  • 6.2.1 Requirements for Using the RDC Onsite Password Utility
  • 6.2.2 Resetting versus Changing Passwords
  • 6.2.3 Configuring the Reset Password Link
• 6.3 Customizing the Co-brand Logo
• 6.4 Customizing the Contact Us Link
• 6.5 Customizing the Change Password Link
  • 6.5.1 Changing the URL and the Name for the Change Password Link
  • 6.5.2 Enforcing Profile Limits for the Change Password Page
• 6.6 Customizing the Electronic Signature (Approval) Warning Message
  • 6.6.1 Customizing the Approval Warning Messages for the Data Entry Window
  • 6.6.2 Customizing the Approval Warning Messages for the Application Pages
  • 6.6.3 Other Options for Customizing Approvals
• 6.7 Customizing the Logout Message
• 6.8 Setting the User Session Timeout Value
  • 6.8.1 Recommendations for Setting the Session Timeout Value
  • 6.8.2 Changing the Session Timeout Value
  • 6.8.3 Adjusting the jbo.ampool.maxinactiveage Setting
• 6.9 Setting the Maximum Number of Rows Fetched
• 6.10 Storing Custom Web Pages
• 6.11 Storing the DCIF Images

7 Working with the RDC Client Package

• 7.1 Deriving Company-Specific Document Numbers
• 7.2 Configuring a Timer Period for Subsequent Electronic Signatures
• 7.3 Configuring the DCI Bookmark Label for the Patient Data Report
• 7.4 Configuring the DCM Bookmark Label for the Patient Data Report
• 7.5 Configuring the Visit Bookmark Label for the Patient Data Report

8 Configuring News

• 8.1 About the News Section in RDC Onsite
• 8.2 Creating User Roles that Can Define News Items Only
• 8.3 Creating and Modifying News Items
  • 8.3.1 Accessing the Form for Defining News Items
  • 8.3.2 Priority and Sequence of News Items
  • 8.3.3 Substitution Parameters for News Items
• 8.4 Querying News Definitions

9 Customizing Activities

• 9.1 Displaying the Activities List
• 9.2 Default Activities for RDC Onsite
• 9.3 Key Concepts for Activities
  • 9.3.1 User Roles and Activities
  • 9.3.2 Types of Activities
  • 9.3.3 Scope of Activities
• 9.4 Activities Database Tables
  • 9.4.1 RDC_ACTIVITIES Database Table
  • 9.4.2 RDC_ACTIVITY_TAGS Database Table
• 9.5 Activity Tags and Functions Included with Oracle Clinical
• 9.6 Creating and Maintaining Customized Activities
  • 9.6.1 Working with the RDC_ACTIVITIES Table
    • 9.6.1.1 Copying Activities
    • 9.6.1.2 Deleting Activities
  • 9.6.2 Creating an Activity Procedure
  • 9.6.3 Adding Counts to Existing Activities
• 9.7 Creating an Activity Tag Function

10 Configuring Links

• 10.1 About Custom Links
  • 10.1.1 Links on the Home Page
  • 10.1.2 Links on the Patient Summary Report
  • 10.1.3 A Link for CRF Help
• 10.2 Using the Maintain Links Form
  • 10.2.1 Ordering the Display of Links
  • 10.2.2 Defining the Link Text
  • 10.2.3 Specifying the URL or Function
  • 10.2.4 Specifying the Type of Link
  • 10.2.5 Specifying the Link Scope
  • 10.2.6 Enabling Patient Summary and CRF Help Links
• 10.3 Link Parameters
  • 10.3.1 Parameters for Static Links Based on Scope
  • 10.3.2 Parameters for Dynamic Links Based on Scope
    • 10.3.2.1 Sample Function Available
    • 10.3.2.2 Function Specification for Dynamic Links
• 10.4 Creating Links for the Home Page
  • 10.4.1 Defining a Link for the Home Page
  • 10.4.2 Parameters for Links with a Scope of None
  • 10.4.3 Parameters for Links with a Scope of User
  • 10.4.4 Parameters for Links with a Scope of Study
  • 10.4.5 Parameters for Links with a Scope of Site
  • 10.4.6 Customizing the Label for the Links Section
• 10.5 Defining Links for the Patient Summary Reports
  • 10.5.1 Parameters for a Patient Link
• 10.6 Defining a Link for CRF Help
  • 10.6.1 Parameters for a CRF Help Link
• 10.7 Querying Link Definitions
• 10.8 About Storing Your Customized Web Pages

11 Customizing Online Help

• 11.1 Defining Help for the Fields in a CRF
• 11.2 Customizing Online Help
  • 11.2.1 Copying the RDC Onsite Help Files
  • 11.2.2 Identifying Individual Topic Files
  • 11.2.3 Modifying the Topic Text
  • 11.2.4 Diverting the Help Call to a Custom Location
• 11.3 Defining Help for CRFs

12 Configuring Settings for Reports

• 12.1 Defining Settings for the Patient Data Report
  • 12.1.1 Defining the Configuration Settings for the Patient Data Report
    • 12.1.1.1 Defining Report Settings at the Database Level
    • 12.1.1.2 Defining Report Settings at the Study Level
  • 12.1.2 About the Patient Data Report Settings
• 12.2 Customizing Bookmark Labels
• 12.3 Printing Left Default Prompts for Repeating Response Fields

13 Generating Reports from the Command Line

• 13.1 Configuring Desktop PDR for Report Generation
  • 13.1.1 Contents of the desktoppdr Folder
  • 13.1.2 Installing the Java Runtime Environment
  • 13.1.3 Copying the Files in the desktoppdr Folder
  • 13.1.4 Copying and Modifying the xdo.cfg File
  • 13.1.5 Modifying the RunPDR.cmd File
  • 13.1.6 Modifying the RunBlankCasebook.cmd File
  • 13.1.7 Adjusting the Heap Size for the Java Virtual Machine (JVM)
    • 13.1.7.1 Adjusting JVM Heap Size Options for the Desktop
    • 13.1.7.2 Adjusting JVM Heap Size Options on the Reports Server
• 13.2 Generating a Patient Data Report from the Command Line
  • 13.2.1 Displaying the Command Syntax
  • 13.2.2 Parameters for the RunPDR Command
• 13.3 Generating a Blank Casebook Report from the Command Line
  • 13.3.1 Displaying the Syntax for the RunBlankCasebook Command
  • 13.3.2 Parameters for the RunBlankCasebook Command
• 13.4 File Names for Reports Generated from the Command Line

14 Collecting Debug Data

• 14.1 Enabling a SQL Trace for Searches
• 14.2 Displaying Document Numbers in the RDC Onsite Application
• 14.3 Displaying Discrepancy IDs in the RDC Onsite Application
• 14.4 Debugging the Patient Data Report
• 14.5 Debugging the RDC Onsite Application
  • 14.5.1 About the Error Messages in RDC Onsite
  • 14.5.2 Locating the RDC Onsite Log Files
    • 14.5.2.1 Changing the Location of the Data Entry Logs
  • 14.5.3 Setting the Log File Size and Number
  • 14.5.4 Configuring the Level of Detail for Log Files
  • 14.5.5 Enabling the Logging of Debug Information
  • 14.5.6 Reviewing the Log Entries for the RDC Onsite Application Pages
  • 14.5.7 Reviewing the Log Entries for Data Entry
  • 14.5.8 Locating Log Files for a Fatal Failure during Data Entry
  • 14.5.9 Data Capture API (DCAPI) Logs
    • 14.5.9.1 Location of DCAPI Log Files
    • 14.5.9.2 Log Level for DCAPI Log Files
    • 14.5.9.3 Enabling DCAPI Logging
    • 14.5.9.4 Locating DCAPI Log Entries
  • 14.5.10 Data Capture API (DCAPI) Framework Logs
  • 14.5.11 Dump File for a Data Entry Fatal Failure Error
    • 14.5.11.1 Location of the Dump File
    • 14.5.11.2 Enabling Dump File Creation
    • 14.5.11.3 Reading a Dump File
  • 14.5.12 Viewing Additional Log Files of Interest
  • 14.5.13 Comparison of the Log Files in RDC Onsite 4.6.2, 4.6, and 4.5.3
• 14.6 Debugging Performance Issues in the Data Entry Window
  • 14.6.1 Performance Profiling for the Data Entry Client
  • 14.6.2 Performance Profiling for Data Entry Server Code
• 14.7 Tracking Scalability Data for RDC Onsite
  • 14.7.1 Enabling Tracking of Scalability
  • 14.7.2 Viewing the Scalability Metrics

A Setting Up Database Connections

• A.1 Setting Up the SQL*Net Connections for Existing Databases
• A.2 Using the OPAAdmin Application to Set Up Database Connections
• A.3 Managing Users and Passwords for the OPAAdmin Application
  • A.3.1 Navigating to the Users Page for the OPAAdmin Application
  • A.3.2 Changing the Password for the opaconfig User
  • A.3.3 Creating a New User with Access to the OPAAdmin Application
  • A.3.4 Resetting a Forgotten Password for an OPAAdmin User
  • A.3.5 Revoking User Access to the OPAAdmin Application

B Generating HTML DE and PDR Templates for Existing DCI Form Versions

• B.1 Creating User Roles that Can Upgrade DCI Forms Only
• B.2 Upgrading Existing DCI Form Versions for HTML DE and New PDRs
• B.3 Running the Upgrade Utility in Incremental Mode

Glossary