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Oracle® Clinical Remote Data Capture Onsite Administrator's Guide
Release 5.0.1
E37004-02
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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 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
1.3
Starting the Oracle Clinical Application
1.4
Modifying Files on the Application Server
1.5
Stop the WebLogic Admin Server
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
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
3.2.3.1
Required Parameters in an rdcConfig.properties File
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
Making a Reason for Change Optional for Updates to RDCI Comments in Accessible Documents
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, Button, or Link for RDC Onsite
6.1.1
Creating or Customizing a Launch Page to Use Provided Scripts
6.1.1.1
Sample Java Script for Launching in a New Window without Tool or Menu Bar
6.1.1.2
Sample JavaScript for Checking if Compatibility View Is On
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
6.9
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
Embedding Type 1 Fonts into the Patient Data Report
13.1.4.1
Copying and Configuring the xdobookbinder.cfg File for Embedding Type 1 Fonts
13.1.4.2
Embedding Type 1 Fonts when Generating Reports from the Command Line
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
14.5.3
Enabling the Logging of Debug Information
14.5.4
Reviewing the Log Entries for the RDC Onsite Application Pages
14.5.5
Reviewing the Log Entries for Data Entry
14.5.6
Locating Log Files for a Fatal Failure during Data Entry
14.5.7
Data Capture API (DCAPI) Logs
14.5.7.1
Location of DCAPI Log Files
14.5.7.2
Log Level for DCAPI Log Files
14.5.7.3
Enabling DCAPI Logging
14.5.7.4
Locating DCAPI Log Entries
14.5.8
Data Capture API (DCAPI) Framework Logs
14.5.9
Dump File for a Data Entry Fatal Failure Error
14.5.9.1
Location of the Dump File
14.5.9.2
Enabling Dump File Creation
14.5.9.3
Reading a Dump File
14.5.10
Viewing Additional Log Files of Interest
14.5.11
Comparison of the Log Files in RDC Onsite 5.0.0, 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
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
D
Deploying Customizations
D.1
Delete Existing Deployment
D.2
Redeploy Version with Customizations
D.3
Restart Opaserver
Glossary