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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 Clinical Documentation
Conventions
1
Getting Started with Administration Tasks
1.1
About Administrator Privileges for Maintaining RDC
1.1.1
About Database Roles for RDC 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
1.3
Starting the Oracle Clinical Application
1.4
Setting Web Command Access
1.5
Stop the WebLogic Admin Server
2
Securing Remote Data Capture
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
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
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
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 CRF Group Actions
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
3.3.9
Suppressing the Validation Error Alert
3.4
Required Parameters in an rdcConfig.properties File
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
Configuring Custom Review Types
5.1
Review Statuses for Custom Review Types
5.2
Define Custom Review Type Requirements
5.2.1
Set Custom Review Requirement for the Installation
5.2.2
Set the Custom CRF Review Requirement for a Study
5.2.3
Set Custom Review Requirement for a GLIB DCI
5.2.4
Set Custom Review Requirement for a Study DCI
5.3
Finding CRFs with the Review Not Required (RN) Status Set by Users
5.4
Viewing Audit History for Changes in Custom Review Requirements
5.5
Add Custom Review Types
5.5.1
Deactivate Custom Review Types
5.6
Assign Custom Review Type Privileges to Users
5.7
Define Custom Review Type Activities
6
Customizing Data Entry Behavior
6.1
Configuring the DCI Form Runtime Settings
6.1.1
Defining the DCI Form Runtime Settings at the Database Level
6.1.2
Defining Report Settings at the Study Level
6.1.3
Enabling HTML Data Entry for RDC
6.1.4
Displaying the Visit-Owning Interval on the Casebooks Page
6.1.5
Allowing Investigator Comments
6.1.6
Adding a Customized
Reference
Field to the Search Pane
6.1.6.1
Searching and Viewing Enhancements for the Customized Field
6.1.6.2
Labeling and Enabling Your Customized Search Field
6.1.6.3
Writing the Derivation Procedure to Use Your Customized Field
6.1.7
Controlling the Display of Conditional Blocks within a CRF
6.1.8
Suppressing Prompts and Warnings
6.1.8.1
Suppressing the Change Reason Prompt for New Responses
6.1.8.2
Suppressing the Change Reason Prompt for Investigator Comments
6.1.8.3
Suppressing the Warning for Non-migrated CRFs
6.2
Using DCI Book Assignment
6.2.1
Manually Assigning Patients to DCI Books Using Oracle Clinical
6.2.2
Automatically Assigning the DCI Book upon Initial Data Entry
6.2.3
Allowing Patient Book Assignments to Change
6.3
Specifying CRFs for Single Use
6.4
Customizing the Display of a List of Values
6.5
Defining the List of Allowable Change Reasons
6.5.1
Accessing the Codelists to Customize the Change Reason Values
6.5.1.1
Reserved Change Reason Values
6.5.1.2
Identifying the Default Change Reason
6.5.1.3
Identifying Change Reasons NOT for Use in RDC
6.5.2
Making a Reason for Change Optional for Updates to RDCI Comments in Accessible Documents
6.6
Setting the Format of Dates
6.6.1
Setting Date Formats at the Database Level
6.6.2
Setting Date Formats for Individual Users
7
Customizing RDC on the Application Server
7.1
Modifying Files on the Application Server
7.2
Creating a Launch Page, Button, or Link for RDC
7.2.1
Creating or Customizing a Launch Page to Use Provided Scripts
7.2.1.1
Sample Java Script for Launching in a New Window without Tool or Menu Bar
7.2.1.2
Sample JavaScript for Checking if Compatibility View Is On
7.2.2
Customizing the Remote Data Capture URL
7.2.3
Adding Custom Text to the RDC Onsite Login Page
7.3
Customizing the Reset Password Link
7.3.1
Requirements for Using the RDC Onsite Reset Password Utility
7.3.2
Resetting versus Changing Passwords
7.3.3
Configuring the Reset Password Link
7.4
Customizing Branding Images in RDC
7.5
Customizing the Contact Us Link
7.6
Customizing the Change Password Link
7.6.1
Changing the URL and the Name for the Change Password Link
7.6.2
Enforcing Profile Limits for the Change Password Page
7.7
Customizing the Electronic Signature (Approval) Warning Message
7.7.1
Customizing the Approval Warning Messages for the Data Entry Window
7.7.2
Customizing the Approval Warning Messages for the Application Pages
7.7.3
Other Options for Customizing Approvals
7.8
Customizing the Logout Message
7.9
Setting the User Session Timeout Value
7.9.1
Recommendations for Setting the Session Timeout Value
7.9.2
Changing the Session Timeout Value
7.10
Setting the Maximum Number of Rows Fetched
7.11
Storing Custom Web Pages
7.12
Storing the DCIF Images
7.13
Customizing the Single View of the Patient Casebooks Page
7.13.1
Activating One-Click Navigation to the Single View of Patient Casebooks Page
7.13.2
Deactivating the Single View for the Patient Casebooks Page
7.14
Hiding Unplanned Visit Buttons in RDC Onsite
8
Working with the RDC Client Package
8.1
Deriving Company-Specific Document Numbers
8.2
Configuring a Timer Period for Subsequent Electronic Signatures
8.3
Configuring the DCI Bookmark Label for the Patient Data Report
8.4
Configuring the DCM Bookmark Label for the Patient Data Report
8.5
Configuring the Visit Bookmark Label for the Patient Data Report
9
Configuring News
9.1
About the News Section in RDC
9.2
Creating User Roles that Can Define News Items Only
9.3
Creating and Modifying News Items
9.3.1
Accessing the Form for Defining News Items
9.3.2
Priority and Sequence of News Items
9.3.3
Substitution Parameters for News Items
9.4
Querying News Definitions
10
Customizing Activities
10.1
Displaying the Activities List
10.2
Default Activities for RDC
10.3
Key Concepts for Activities
10.3.1
User Roles and Activities
10.3.2
Types of Activities
10.3.3
Scope of Activities
10.4
Activities Database Tables
10.4.1
RDC_ACTIVITIES Database Table
10.4.2
RDC_ACTIVITY_TAGS Database Table
10.5
Activity Tags and Functions Included with Oracle Clinical
10.6
Creating and Maintaining Customized Activities
10.6.1
Working with the RDC_ACTIVITIES Table
10.6.1.1
Copying Activities
10.6.1.2
Deleting Activities
10.6.2
Creating an Activity Procedure
10.6.3
Adding Counts to Existing Activities
10.7
Creating an Activity Tag Function
11
Configuring Links
11.1
About Custom Links
11.1.1
Links on the Home Page
11.1.2
Links on the Patient Summary Report
11.1.3
A Link for CRF Help
11.2
Using the Maintain Links Form
11.2.1
Ordering the Display of Links
11.2.2
Defining the Link Text
11.2.3
Specifying the URL or Function
11.2.4
Specifying the Type of Link
11.2.5
Specifying the Link Scope
11.2.6
Enabling Patient Summary and CRF Help Links
11.3
Link Parameters
11.3.1
Parameters for Static Links Based on Scope
11.3.2
Parameters for Dynamic Links Based on Scope
11.3.2.1
Sample Function Available
11.3.2.2
Function Specification for Dynamic Links
11.4
Creating Links for the Home Page
11.4.1
Defining a Link for the Home Page
11.4.2
Parameters for Links with a Scope of None
11.4.3
Parameters for Links with a Scope of User
11.4.4
Parameters for Links with a Scope of Study
11.4.5
Parameters for Links with a Scope of Site
11.4.6
Customizing the Label for the Links Section
11.5
Defining Links for the Patient Summary Reports
11.5.1
Parameters for a Patient Link
11.6
Defining a Link for CRF Help
11.6.1
Parameters for a CRF Help Link
11.7
Querying Link Definitions
11.8
About Storing Your Customized Web Pages
12
Customizing Online Help
12.1
Defining Help for the Fields in a CRF
12.2
Customizing Online Help
12.2.1
Copying the RDC Help Files
12.2.2
Identifying Individual Topic Files
12.2.3
Modifying the Topic Text
12.2.4
Diverting the Help Call to a Custom Location
12.3
Defining Help for CRFs
13
Configuring Settings for Reports
13.1
Defining Settings for the Patient Data Report
13.1.1
Defining the Configuration Settings for the Patient Data Report
13.1.1.1
Defining Report Settings at the Database Level
13.1.1.2
Defining Report Settings at the Study Level
13.1.2
About the Patient Data Report Settings
13.2
About the File Name for the Deleted CRFs Report
13.3
Customizing Bookmark Labels
13.4
Printing Left Default Prompts for Repeating Response Fields
14
Generating Reports from the Command Line
14.1
Configuring Desktop PDR for Report Generation
14.1.1
Contents of the desktoppdr Folder
14.1.2
Installing the Java Runtime Environment
14.1.3
Copying the Files in the desktoppdr Folder
14.1.4
Copying and Modifying the xdo.cfg File
14.1.5
Embedding Fonts into the Patient Data Report
14.1.5.1
Copying and Configuring the xdobookbinder.cfg File for Fully Embedding Fonts
14.1.6
Modifying the RunPDR.cmd File
14.1.7
Modifying the RunBlankCasebook.cmd File
14.1.8
Adjusting the Heap Size for the Java Virtual Machine (JVM)
14.1.8.1
Adjusting JVM Heap Size Options for the Desktop
14.1.8.2
Adjusting JVM Heap Size Options on the Reports Server
14.2
Generating a Patient Data Report from the Command Line
14.2.1
Displaying the Command Syntax
14.2.2
Parameters for the RunPDR Command
14.3
Generating a Blank Casebook Report from the Command Line
14.3.1
Displaying the Syntax for the RunBlankCasebook Command
14.3.2
Parameters for the RunBlankCasebook Command
14.4
File Names for Reports
15
Collecting Debug Data
15.1
Displaying Document Numbers in the RDC Application
15.2
Displaying Discrepancy IDs in the RDC Application
15.3
Debugging the Migration Utility
15.4
Debugging the Patient Data Report
15.5
RDC Log Files
15.5.1
Locating the WebLogic Server Log Files
15.5.2
Setting Up Debugging
15.5.2.1
Editing the logging.xml file for Debugging
15.5.2.2
Editing the URL for Debugging
15.5.3
Types of Log Files
15.5.3.1
RDC Application Pages Log Files
15.5.3.2
RDC Data Entry Window Log Files
15.5.3.3
Data Capture API (DCAPI) Logs
15.5.3.4
Data Capture API (DCAPI) Framework Logs
15.5.4
Enabling a SQL Trace for Searches
15.5.5
Error when a Failure Occurs during Data Entry
15.5.6
Locating Log Files for a Fatal Failure during Data Entry
15.5.7
Dump File for a Data Entry Fatal Failure Error
15.5.7.1
Location of the Dump File
15.5.7.2
Enabling Dump File Creation
15.5.7.3
Reading a Dump File
15.6
Debugging Performance Issues in the Data Entry Window
15.6.1
Performance Profiling for the Data Entry Client
15.6.2
Performance Profiling for Data Entry Server Code
15.7
Tracking Scalability Data for RDC
15.7.1
Enabling Tracking of Scalability
15.7.2
Viewing the Scalability Metrics
A
Setting Up Database Connections
A.1
Adding WebLogic Server Data Sources
A.2
Add Service Name to tnsnames.ora
A.3
Configure Maximum Connections
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
C
Troubleshooting
C.1
CLOB Conversion Error Opening Data Entry Window
C.2
Executable Creation Error Opening Data Entry Window
C.3
Data Entry Window Doesn't Open
C.4
RWServlet URL Connection Error
C.5
Dcapi error saying dll already loaded
C.6
Closing discrepancy of batch loaded CRF error
C.7
Application Hangs When User Tries to Open a New Window
C.8
Cannot Log In to Application
C.9
Oracle Clinical or RDC Not Launching
C.10
Cannot Stop Submitted Report Jobs from RDC Onsite
D
Deploying Customizations
D.1
Locating the olsardc.ear File
D.2
Manually Extracting and Repacking the olsardc.ear File
D.3
Deleting the Existing Deployment
D.4
Redeploying RDC with Customizations
D.5
Restarting the OPA Server
Glossary
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