Contents

List of Examples

List of Figures

List of Tables

Title and Copyright Information

Preface

• Audience
• Documentation Accessibility
• Related Documents
• Conventions

1 Getting Started with Administration Tasks

• About Administrator Privileges for Maintaining RDC Onsite
  • About Database Roles for RDC Onsite Users
  • About User Roles with Limited Administrator Privileges
• Starting the RDC Administration Application
  • RDC Administration Main Window
  • About Maintain Mode versus Query Mode
  • About the Searches Option
• Starting the Oracle Clinical Application
• Modifying Files on the Application Server
• Stopping and Restarting the rdc OC4J Instance

2 Securing RDC Onsite

• About Security Privileges
  • Minimum Requirement for Privileges
  • Privileges and Batch-Loaded CRFs
  • Site Privileges Take Precedence Over Study Privileges
• Assigning Study and Site Security Privileges
  • Opening the Security Privileges Forms
  • Configuring Study and Site Security Privileges
  • Granting Administrator Privileges to Individual Users
• Granting Oracle Clinical Users Access to RDC Onsite
• Managing Security with Data Entry Configuration Settings
  • Changing the Data Entry Configuration Settings
  • Authority to Resolve Discrepancies upon Discrepancy Creation
  • Authority to Update Locked CRFs and Override Repeating Defaults
  • Modifying Data Entry Configurations at the Database, Study, and User Levels
    • At the Local Database Level
    • At the Study Level or the User Level
• Restricting Actions Against Locked CRFs
• Restricting Access to Data Collection Instruments (DCIs)
  • Changing the Default Access to DCIs
  • Defining DCI Access within a Study
    • Opening the Maintain Access to DCIs within Study Form

3 Customizing with RDC Configurations

• About the RDC Configurations
  • Default Configurations
  • Assignment Parameters
    • Default Value (%) for Assignment Parameters
    • Assigning Configurations
    • Precedence and Parsing of Assignment Parameters
• Managing RDC Configurations
  • Opening and Using the RDC Configurations Form
  • Creating a New Configuration
  • Specifying the Settings for a Configuration
  • Assigning Configurations to Users
    • Modifying the Existing Assignments for a Configuration
    • Creating New Assignments for an Existing Configuration
  • Deleting Assignments and Configurations
  • RDC Configurations in the Oracle Clinical Reference Local Codelists
• Configuration Settings for RDC Onsite
  • Customizing the Label for the Links Section on the Home Page
  • Hiding the Preferences Links
  • Displaying Time Stamps in Local Time
  • Allowing Group Verifications and Approvals
  • Using the Oracle Clinical Accessibility Rules
  • Disabling the Save Complete Prompt
  • Specifying a Default Highlighting Scheme for the Data Entry Window
  • Allowing Access to CRFs Entered via Oracle Clinical or RDC Classic
  • Suppressing the Validation Error Alert

4 Configuring Discrepancy Management

• Tools for Configuring Discrepancy Management
• Defining the Reasons for Discrepancies
  • Defining the Reasons for Manual Discrepancies
  • Defining the Reasons for Univariate Discrepancies
  • Defining the Reasons for Multivariate Discrepancies
• Defining the Review Statuses for Discrepancies
  • Default Entries for the DISCREPANCY REV STATUS CODE Codelist
  • Rules for the DISCREPANCY REV STATUS CODE Codelist
• Configuring the Access Statuses for Discrepancies
  • Access Status Values
  • Colors Used to Indicate Discrepancy Access Status
  • Default Entries for the DISCREPANCY STATUS role Codelists
  • Rules for the DISCREPANCY STATUS role Codelist
• Configuring the Actions Allowed against Discrepancies
  • Default Entries for the DISCREPANCY ACTIONS role Codelists
  • Rules for the DISCREPANCY ACTIONS role Codelist
• Defining the Resolution Reasons for Discrepancies
• Preventing Update to OTHER Discrepancies

5 Customizing Data Entry Behavior

• Configuring the DCI Form Runtime Settings
  • Defining the DCI Form Runtime Settings at the Database Level
  • Defining Report Settings at the Study Level
  • Enabling HTML Data Entry for RDC Onsite
  • Displaying the Visit-Owning Interval on the Casebooks Page
  • Allowing Investigator Comments
  • Adding a Customized Reference Field to the Search Pane
    • Searching and Viewing Enhancements for the Customized Field
    • Labeling and Enabling Your Customized Search Field
    • Writing the Derivation Procedure to Use Your Customized Field
  • Controlling the Display of Conditional Blocks within a CRF
  • Suppressing Prompts and Warnings
    • Suppressing the Change Reason Prompt for New Responses
    • Suppressing the Change Reason Prompt for Investigator Comments
    • Suppressing the Warning for Non-migrated CRFs
• Using DCI Book Assignment
  • Manually Assigning Patients to DCI Books Using Oracle Clinical
  • Automatically Assigning the DCI Book upon Initial Data Entry
  • Allowing Patient Book Assignments to Change
• Specifying CRFs for Single Use
• Customizing the Display of a List of Values
• Defining the List of Allowable Change Reasons
  • Accessing the Codelists to Customize the Change Reason Values
    • Reserved Change Reason Values
    • Identifying the Default Change Reason
    • Identifying Change Reasons NOT for Use in RDC Onsite
  • Suppressing the Reason for Change Dialog Box
• Setting the Format of Dates
  • Setting Date Formats at the Database Level
  • Setting Date Formats for Individual Users

6 Customizing RDC Onsite on the Application Server

• Setting Up the Application for HTTPS
• Creating a Launch Page for RDC Onsite
  • Setting Up A Link to Launch RDC Onsite
    • Sample JavaScript for Creating a Link to RDC Onsite
    • Sample HTML for Creating a Button or Link to RDC Onsite
  • Customizing the RDC Onsite URL
• Customizing the Reset Password Link
  • Requirements for Using the RDC Onsite Password Utility
  • Resetting versus Changing Passwords
  • Configuring the Reset Password Link
• Customizing the Co-brand Logo
• Customizing the Contact Us Link
• Customizing the Change Password Link
  • Changing the URL and the Name for the Change Password Link
  • Enforcing Profile Limits for the Change Password Page
• Customizing the Electronic Signature (Approval) Warning Message
  • Customizing the Approval Warning Messages for the Data Entry Window
  • Customizing the Approval Warning Messages for the Application Pages
  • Other Options for Customizing Approvals
• Setting the User Session Timeout Value
  • Recommendations for Setting the Session Timeout Value
  • Changing the Session Timeout Value
• Setting the Maximum Number of Rows Fetched
• Storing Custom Web Pages
• Storing the DCIF Images
• Setting the Keep Alive Timeout

7 Working with the RDC Client Package

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

8 Configuring News

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

9 Customizing Activities

• Displaying the Activities List
• Default Activities for RDC Onsite
• Key Concepts for Activities
  • User Roles and Activities
  • Types of Activities
  • Scope of Activities
• Activities Database Tables
  • RDC_ACTIVITIES Database Table
  • RDC_ACTIVITY_TAGS Database Table
• Activity Tags and Functions Included with Oracle Clinical
• Creating and Maintaining Customized Activities
  • Working with the RDC_ACTIVITIES Table
    • Copying Activities
    • Deleting Activities
  • Creating an Activity Procedure
  • Adding Counts to Existing Activities
• Creating an Activity Tag Function

10 Configuring Links

• About Custom Links
  • Links on the Home Page
  • Links on the Patient Summary Report
  • A Link for CRF Help
• Using the Maintain Links Form
  • Ordering the Display of Links
  • Defining the Link Text
  • Specifying the URL or Function
  • Specifying the Type of Link
  • Specifying the Link Scope
  • Enabling Patient Summary and CRF Help Links
• Link Parameters
  • Parameters for Static Links Based on Scope
  • Parameters for Dynamic Links Based on Scope
    • Sample Function Available
    • Function Specification for Dynamic Links
• Creating Links for the Home Page
  • Defining a Link for the Home Page
  • Parameters for Links with a Scope of None
  • Parameters for Links with a Scope of User
  • Parameters for Links with a Scope of Study
  • Parameters for Links with a Scope of Site
  • Customizing the Label for the Links Section
• Defining Links for the Patient Summary Reports
  • Parameters for a Patient Link
• Defining a Link for CRF Help
  • Parameters for a CRF Help Link
• Querying Link Definitions
• About Storing Your Customized Web Pages

11 Customizing Online Help

• Defining Help for the Fields in a CRF
• Customizing Online Help
  • Copying the RDC Onsite Help Files
  • Identifying Individual Topic Files
  • Modifying the Topic Text
  • Diverting the Help Call to a Custom Location
• Defining Help for CRFs

12 Configuring Settings for Reports

• Defining Settings for the Patient Data Report
  • Defining the Configuration Settings for the Patient Data Report
    • Defining Report Settings at the Database Level
    • Defining Report Settings at the Study Level
  • About the Patient Data Report Settings
• Customizing Bookmark Labels
• Printing Left Default Prompts for Repeating Response Fields

13 Generating Reports from the Command Line

• Configuring Desktop PDR for Report Generation
  • Contents of the desktoppdr Folder
  • Installing the Java Runtime Environment
  • Copying the Files in the desktoppdr Folder
  • Copying and Modifying the xdo.cfg File
  • Modifying the RunPDR.cmd File
  • Modifying the RunBlankCasebook.cmd File
  • Adjusting the Heap Size for the Java Virtual Machine (JVM)
    • Adjusting JVM Heap Size Options for the Desktop
    • Adjusting JVM Heap Size Options on the Report Server
• Generating a Patient Data Report from the Command Line
  • Displaying the Command Syntax
  • Parameters for the RunPDR Command
• Generating a Blank Casebook Report from the Command Line
  • Displaying the Syntax for the RunBlankCasebook Command
  • Parameters for the RunBlankCasebook Command
• File Names for Reports Generated from the Command Line

14 Collecting Debug Data

• Enabling a SQL Trace for Searches
• Displaying Document Numbers in the RDC Onsite Application
• Displaying Discrepancy IDs in the RDC Onsite Application
• Debugging the Patient Data Report
• Debugging the RDC Onsite Application
  • About the Error Messages in RDC Onsite
  • Locating the Log Files
    • Changing the Location of the Data Entry Logs
  • Setting the Log File Size and Number
  • Configuring the Level of Detail for Log Files
  • Enabling the Logging of Debug Information
  • Reviewing the Log Entries for the RDC Onsite Application Pages
  • Reviewing the Log Entries for Data Entry
  • Locating Log Files for a Fatal Failure during Data Entry
  • Data Capture API (DCAPI) Logs
    • Location of DCAPI Log Files
    • Log Level for DCAPI Log Files
    • Enabling DCAPI Logging
    • Locating DCAPI Log Entries
  • Data Capture API (DCAPI) Framework Logs
  • Dump File for a Data Entry Fatal Failure Error
    • Location of the Dump File
    • Enabling Dump File Creation
    • Reading a Dump File
  • Viewing Additional Log Files of Interest
  • Comparison of the Log Files in RDC Onsite 4.6 and 4.5.3
• Debugging Performance Issues in the Data Entry Window
  • Performance Profiling for the Data Entry Client
  • Performance Profiling for Data Entry Server Code
• Tracking Scalability Data for RDC Onsite
  • Enabling Tracking of Scalability
  • Viewing the Scalability Metrics

A Database Connections

• Setting Up the SQL*Net Connections for Existing Databases
• Setting Up Database Connections in the opaadmin Utility
• Creating a New User with Access to the opaconfig Form
• Revoking User Access to the opaconfig Form

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

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

Glossary