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Oracle® Clinical Remote Data Capture Classic Data Entry User's Guide
Release 4.6.2
Part Number E18824-01
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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
Part I RDC Classic Concepts and Conventions
1
Introduction
RDC Classic and Electronic Data Capture
Discussion
How RDC Classic Works
Interaction with Oracle Clinical
System Requirements
System Requirements for All Users
Hardware Requirements
Network Access
Software Requirements
Software Settings for Required Applications
Microsoft Internet Explorer
Adobe Reader or Acrobat
Required Information
Web Site Information
User Name
Password
Database Name
General Concepts and Terms
RDC Classic Session
Default Study
Initial Study Selection
RDC Classic-enabled Studies
Source Data
Saving Data
Saving Changes
Auditing Data
Why Data Changes Are Audited
What Information Is Audited
Using Status Information
Main Application Window Title Bar
Spreadsheet Status Line
Default Status Line
Typical Status Line Information
Using the Keyboard to Assist RDC Classic Tasks
Accessing Menu Commands
Using the Function Keys
Navigating in the Data Entry Window
Verifying the Name of the Current Study
Security — Roles and Privileges
Roles
Privileges
Minimum Requirement
Batch Loaded CRFs
Inclusion
Precedence
Site-level Privileges and Search Criteria
RDC Classic Workflows
Initial Data Entry
General Workflow for Initial Data Entry
Scenario 1 — Save CRF in Created Status
Scenario 2 — Create CRF and Proceed to Data Entry
Run a Report
Unlock a CRF for Update
2
CRFs
Discussion
Types of CRFs
Components of CRFs
Header and Footer
CRF Sections
CRF Statuses
CRFs
CRF Header
Complete the CRF Header
CRF Sections
Section Header
Question Area
Blank Flag
Prerequisites
Disposition of Existing Data
Cascading Between the CRF and CRF Section
CRF Status
Discussion
Data Entry Status
CRF Lock/Unlock
Discrepancy Status
Color-coded Response Fields
Approval Status
Verification Status
Overview of the Data Entry Process
Discussion
Adjust Data Entry Preferences
3
RDC Classic Discrepancy Management
Discrepancies in RDC Classic
Types of Discrepancies
System-generated Discrepancies
How the System Generates Discrepancies
Impact of Study Design on Discrepancies
Univariate Discrepancy
Multivariate Discrepancy
Indicator Question Discrepancy
User-generated Discrepancies
Manual Discrepancy
Section Discrepancy
How Users Generate Discrepancies
Discrepancy Classifications
Discrepancy States
Current Discrepancies
Obsolete Discrepancies
Current Discrepancy Statuses
Open Discrepancy Statuses
Closed Discrepancy Status
Discrepancy Actions
Initiating a Discrepancy
Routing a Discrepancy
Discrepancy Resolution Actions
System Obsolete
Discrepancy Basics
Managing Discrepancies
Evaluating and Responding to Validation Errors
Initiating a Manual Discrepancy
Reviewing Discrepancies
Evaluating and Taking Action on Edit Check Discrepancies
Acknowledge Discrepant Data and Include a Comment
Route the Discrepancy
Resolve the Discrepancy
4
Reports in RDC Classic
Discussion of the PDR
Types of Reports
Requirements
Format
Components of PDRs
Discussion
Page Numbering
Cover Page
Blank Workbook PDRs
Patient CRF PDRs
CRF Data Section
CRF Header Information
CRF Section Header Information
Approval and Verification Notices
Response Data
Format of Data Values
End Notes
Links to Other Sections
Audit History Report Section
Discrepancy Detail Report Section
Deleted CRFs Section
Part II Data Entry Tasks
5
Getting Started
Start Your RDC Classic Session
Connect to the Sponsor Site
Navigate to the RDC Classic Launch Page
Notes
Log In to RDC Classic
Prerequisites
Procedure
Notes
Change Your Login Password
Procedure
Select an Initial Study
Review News Items During Session Startup
Procedure
Select a Workset
Work with Patients
Select a Patient
Navigate in the Patient List
Include a Specific Patient in the Workset
Insert a New Patient
Work with CRFs
Open a New or Existing CRF
Note
Add an Unplanned CRF
Procedure
Show or Hide Unplanned CRFs
Spreadsheet View
Workset
View Summary Information for a CRF
Delete a CRF
Add an Unplanned CRF to a Planned Visit
Add an Unplanned CRF to an Unplanned Visit
Work with Visits
Show/Hide Unplanned Visits
Show Unplanned Visits
Hide Unplanned Visits
Add an Unplanned Visit to a Study
Procedure
Notes
Validation Tasks
Validate a Patient
Validate a Site
Notes
Validate a Study
Modify the Workset
Refresh the Workset
Change the Study During an RDC Classic Session
Procedure
Modify the Search Criteria
Discussion
Change the Current Book
Use the Search Window to Change the Active Book
Use Data Entry to Change the Active Book
Change the Current Site
Search Window Procedure
Activity List Window Procedure
Notes
Lock and Unlock CRF Procedures
Lock an Individual CRF
Unlock a CRF
Assign the Capability to Update a Locked CRF
Remove User Names from List to Lock CRF
Notes
Miscellaneous Tasks During an RDC Classic Session
Change Preferences During a Session
View News Items During a Session
Use the Links Task Tab During a Session
Access Online Help
Main Help
Context-sensitive Help
CRF Icon Legend
End Your RDC Classic Session
Process Pending Changes
Save Pending Changes
Discard Pending Changes
Exit RDC Classic
6
Select a Workset
Discussion
Default Settings
Which Method to Use
Access
Using the Search Window to Select Worksets
Strategies to Best Use the Search Window
Common Search Window Tasks
Find all Discrepant CRFs at a Site
Find all CRFs from a Date Range for Set of Patient Numbers
Find all Specific Type CRFs that Require Re-verification
Worksets for Discrepancy Management
Specify a Workset for Group Procedures
Define a Workset to Change Verification Status of a Group
Define a Workset to Change Approval Status of a Group
Using the Activity List Window
Discussion
Alternative to Search Window
Configuration Settings
Interaction with the Summary Task Tab
Access the Activity List Window
Accessing the Activity List Window
Initial Display of the Activity List Window
Open the Activity List Window
Access the Activity List Window
Usage
Select an Initial Activity
Change the Current Activity
View Sites and Patients in the Navigator Pane
View Activities Associated with a Node
View Summary Information
Change Studies from the Activity List Window
Access the Search Window from the Activity List Window
Close the Activity List Window
Using Saved Searches
Overview of Saved Searches
Components of a Saved Search
Scope of a Saved Search
Default Search/Filter
Default Search in the Search Window
Default Filter in the Activity List Window
Saved Search Tasks
Save a Search
Load a Saved Search
Modify an Active Saved Search
Load a Filter in the Activity List Window
Deactivate a Saved Search or Filter
Specify a Default Search or Filter
Maintaining Saved Searches
General Rules for Maintaining Searches
Maintain Save Search Rules for Non-Administrator Users
Maintain Saved Search Rules for Administrator Users
Change the Study Scope of a Saved Search
Create a Copy of a Saved Search
Delete a Saved Search
View the Query Associated with a Saved Search
7
Group Activities
Discussion
Group Activities Interaction with Other RDC Classic Components
Blank Flag
Multi-section CRFs
Spreadsheet Refresh
Spreadsheet View
Unplanned Visits and CRFs
Patient List
Open Windows
Pending Changes
Access
Site Criteria
Group Verification Procedures
Discussion
Verify a Group of CRFs
Procedure
Undo Verification for a Group of CRFs
Procedure
Group Approval Procedures
Discussion
Approve a Group of CRFs
Procedure
Notes
Undo Approval for a Group of CRFs
Procedure
Group Locking Procedure
Lock a Group of CRFs
8
Initial Data Entry
Open a CRF
Initiate Data Entry
View Data in Fields with an ATTACHMENT Prefix
Initiate an Investigator Comment
Evaluate and Respond to a Validation Error During Initial Data Entry
Notes
Mark the CRF Blank During Initial Data Entry
Mark a CRF Section Blank During Initial Data Entry
Insert a Repeating Question Groups Row
Initiate a Discrepancy for a Response Field
Initiate a Section Discrepancy
Notes
Close a CRF
Required Header Fields
Pending Changes
Methods to Close a CRF
9
Data Review and Update
CRFs Review
Review the Audit Trail for a CRF
General Procedure
Procedure Based on the Approval or Verification History
View the Change History for a Response
Review an Investigator Comment
Review the Approval or Verification History of a CRF
Review Discrepancies Associated with a CRF
Update Response Data
Complete the Audit Information Window
Procedure
Update CRF and/or CRF Section Header Data
Procedure
Notes
Update Response Data for a CRF
Procedure
Update an Existing Investigator Comment
Procedure
Notes
Mark a CRF or CRF Section Blank
Clear the Blank Flag and Proceed with Data Entry
Manage Discrepancies
Review Discrepancies
View all Discrepancies
Access the Discrepancy Window
Update an Existing Discrepancy
Discrepancy Task Tab Procedure
Discrepancy Window Procedure
Take Action on a Discrepancy
Route a Discrepancy
Resolve a Discrepancy
CRF Verification Tasks
Review the Verification History
Change the Verification Status of a CRF
Procedure
CRF Approval
Approve a CRF
Undo CRF Approval
10
Study Closeout
Locking and Unlocking CRFs
Running Reports
Patient CRFs Report
Print Patient CRFs Using Current Selections
Print Patient CRFs by Specifying Report Parameters
Blank CRFs Report
Continue Work while a Report Runs
Monitor the Progress of a Report
View and Print a Report
Part III RDC Classic GUI Reference
11
RDC Classic Workspace
Overview of the RDC Classic Workspace
Organization of the RDC Classic Workspace
Workspace Variations
RDC Classic Configurator Settings
User Role
RDC Classic Workspace Components
Main Application Window
Access
Title Bar
Menu Bar
Access
Components
Usage
File Menu
Commands
Usage
Edit Menu
Commands
Usage
Insert Menu
Commands
Usage
CRF Menu
Commands
Group Activities Menu
Commands
Validate Menu
Commands
Help Menu
Commands
Window Menu
Commands
RDC Classic Toolbar
Access
Toolbar Components and Associated Actions
12
RDC Classic Spreadsheet
Discussion
Organization
Purposes of the RDC Classic Spreadsheet
Spreadsheet Focus
Components of the Spreadsheet
Overview
Current Patients
Contents of Current Patients
Groups of Eight
How Search Window Criteria Affect the Patient List
Assigned Patients
Selecting a Patient
Viewing Patients While in Browse Mode
Frozen Patient Numbers
CRF Column
CRF Column Header
Optional CRFs
Visit Number
Page
CRF
Color Coding
Show/Hide Unplanned Pages Button
CRF Cell
Background Color in CRF Cells
Empty CRF Cells
CRF Icons
Spreadsheet Views
Types of Spreadsheet Views
Spreadsheet View Tabs
Spreadsheet View Selection Drop-Down List
Visit Spreadsheet View
Phase Spreadsheet View
Study Spreadsheet View
Navigation and Information Aids
Spreadsheet Focus
Horizontal Scroll Bar
Visit Selection Button
Spreadsheet Status Line
Search Button
Activity List Button
Patient Selection Drop-Down List
13
Task Tabs
Discussion
Data Entry and Display of Task Tabs
Task Tabs and the RDC Classic Spreadsheet
Summary Task Tab
Discussion
Summary Views
Access
Components of the Summary Task Tab
Summary View Drop-Down List
Summary Task Tab Sections
Patient Summary View
Patient Summary Section
Discrepancies Section
CRFs Section
CRF Status Section
Visits Section
Page Summary View
Page Summary
CRFs Section
CRF Status Section
CRF Summary View
CRF Summary Section
Audit Summary Section
Site Summary View
Access
Prerequisites
Components
Study Summary View
Access
Prerequisites
Components
Spreadsheet Summary View
Summary of CRFs Retrieved Section
Summary of CRFs in Current Tab Section
Number of Patients
Usage
Selecting a Summary View from the RDC Classic Workspace
Selecting a Summary view from the Activity List Window
Discrepancy Task Tab
Discussion
Access the Discrepancy Task Tab
Contents Depend on Focus and Status
Visual Cues
Discrepancy Actions
Default Actions
List of Discrepancies Tab
Access
Components
Ordering of Discrepancies in the List
Select a Discrepancy List Item
Individual Discrepancy Tab
Access
Components of an Individual Discrepancy Tab
Usage
Work with the List of Discrepancies Tab
Work with Individual Discrepancy Tabs
Verification Task Tab
Discussion
Access the Verification Task Tab
Contents Depend on Focus, Status, and Privilege
Verification Statuses
Components of the Verification Task Tab
"Not verified" Task Tab Components
Task Tab Components for CRFs Currently or Previously Verified
Approval Task Tab
Discussion
Contents Depend on Focus, Status, and Privilege
Approval Status
Access
Components
"Not Approved" Task Tab Components
Task Tab Components for CRFs Currently or Previously Approved
Audit Trail Task Tab
Discussion
Multi-section CRF
Access
Components
"Changes since" Drop-Down List Box
Links Task Tab
Discussion
Context
Navigation
Access
Components
Status Line
General Links
Study/Site Links
Patient/Page Links
14
General RDC Classic Windows
Windows Associated with Starting Your RDC Classic Session
RDC Classic Launch Page
Access
Components of the Launch Page
Usage
Logon Window
Access
Components of the Logon Window
Change Password Window
Access
Components
Usage
Change Study Window
Access
Components
Usage
News Window
Discussion
Access
Usage
Field Editor Window
Access
Components
Usage
Search and Replace Window
Access
Components
Usage
Activity List Window
Access
RDC Classic Session Startup
During an RDC Classic Session
Components
Title Bar
Navigation Pane
Task Pane
Navigation Buttons
Usage
Saved Search Windows
Save Current Search Window
Access
Components
Usage
List of Saved Searches Window
Components
Usage
Access
Maintain Saved Search Window
Components
Access
Copy Search Window
Components
Usage
Access
SQL Query Window
Components
Usage
Access
Preferences Window
Access
Session Configuration
Components
General Tab Components
Date Format
Debug Settings
System Settings Section
Time Zone Section
Data Entry Tab Components
CRF Progression
Action When Clicking on a Cell
Data Entry Settings
Windows Associated with Running Reports
Reports Window
Access
Components
Report Submission Window
Access
Components
Report parameters
Usage
Submission Details for Report Window
Access
Components
Submitted Batch Jobs Window
Access
Components
Usage
Schedule Jobs Window
Access
Components
Usage
Report Previewer Window
Access
Components
Output File Window
Access
Components
Log File Window
Access
Components
Report Queue Manager Window
Access
Windows Associated with CRF Lock and CRF Unlock Functions
Current CRF Lock Process Window
Access
Components
Usage
Task Reference
Users Who Can Update Window
Access
Components
Usage
Task Reference
Valid User Names Window
Access
Components
Usage
Task Reference
Group Activities Windows
Verification Group Activity Windows
Access
Components
Usage
Task Reference
Approval Group Activity Windows
Access
Components
Usage
Task Reference
Password Confirmation Windows
Access
Components
Usage
Task Reference
Group Lock Window
Access
Components
Usage
Group Procedure Status Windows
Access
Components
Windows Associated with Common Spreadsheet Tasks
Insert New Patient Window
Access
Components
Usage
Task Reference
Add Unplanned CRF Window
Access
Components
Usage
Task reference
Help Windows
Access
From the Help Menu
From the Toolbar
RDC Classic Online Help Window
Access
Components
Response Field Help Window
Access
Context-Sensitive Help Window
CRF Icon Legend Window
Access
Components
About Window
15
Search Window
Discussion
Retrieving Data with the Search Window
Terminology
Access the Search Window
Session Startup
Change Current Study
During a Session
New Search Window
Modify the Search Window
From the Activity List Window
Search Window Components
Book Criterion
Access
Components
Usage
Site Criterion
Access
Components
Usage
Multi-Parameter Criteria
Access
Components
Usage
Search Window Usage
Using the Book and Site Drop-Down List Boxes
Using the Default Buttons
Using the Specify... Buttons
Using the Cancel Button
Session Startup
During a Session
Using the Change Study Button
Subsearch Windows
Patients Subsearch Window
Access
Components
Usage
Visit/Page Range Subsearch Window
Access
Components
Usage
CRF Status Subsearch Window
Access
Components
Usage
CRF/Visit Dates Subsearch Window
Access
Components
Usage
Data Subsearch Window
Access
Components
Usage
16
RDC Classic Windows
Data Entry Window
Discussion
Access
Components
Title Bar
CRF Header
Comment Text Box
CRF Section
Multi-section CRF Data Entry Windows
Sizing Window
Access
Components
Usage
Usage
Complete the CRF Header
Process the Blank Flag in a CRF or CRF Section Header
Re-size the Data Entry Window
Close the Data Entry Window
Task Reference
Windows Associated with Data Entry Tasks
Investigator Comment Window
Access
Components
Usage
Task Reference
Audit Information Window
Discussion
Access
Components
Usage
Task Reference
Audit Change Reason Type Codes Window
Access
Components
Audit History Window
Access
Components
Windows Associated with CRF Approval
Approval Password Confirmation Windows
Discussion
Components
Undo Approval Password Confirmation Window
Access
Components
Windows Associated with Managing Discrepancies
Discrepancy Windows
Discrepancy for CRF Section Window
Access
Components of the CRF Section Discrepancy Window
Comment for Question Window
Access
Components of the Comment for Question Window
Task Reference
Validation Failure Window
Access
Components
Usage
Internal Comments Windows
Internal Comment Window
Internal Comment History Window
Internal Comments for Discrepancy Window
Resolution Reason Window
Access
Components
Discrepancy History Window
Access
Components of the Discrepancy History Window
Part IV RDC Classic Administration Tasks
17
Administering RDC Classic in Oracle Clinical
Enrolling RDC Classic Users
User Groups
User Group Roles
Set Up a New User Group
Define the User Group
Create Discrepancy Reference Codelists
Configuring the RDC Classic Discrepancy System
Setting Discrepancy Groups
Setting Discrepancy Actions
Setting the Change Reason
Limiting Unplanned CRFs in RDC Classic
Maintaining Standard Message Texts
Using the News System
For the Customizer
Maintaining the News Definitions
Working with the RDC_CLIENT Package
News Procedure
Purpose
Parameters
Return Value
Comments
Related Functions
Logic as Shipped
RdciAccess Function
Purpose
Parameters
Return Value
Comments
Logic as Shipped
DeriveDocumentNumber Function
Purpose
Parameters
Return Value
Comments
Logic as Shipped
timeout_mins Function
Purpose
Parameter
Return Value
Comments
Logic as Shipped
get_approval_header Function
Purpose
Parameter
Return Value
Related Functions
Logic as Shipped
get_undo_header Function
Purpose
Parameter
Return Value
Related Functions
Logic as Shipped
lParse_news Function
Purpose
Parameter
Return Value
Comments
Related Functions
Logic as Shipped
getConfigurationModule Function
Purpose
Parameters
Return Value
Logic as Shipped
get_batch_approval_header Function
Purpose
Parameter
Return Value
Related Functions
Logic as shipped
get_batch_approval_undo_header function
Purpose
Parameter
Return value
Related Functions
Logic as Shipped
18
RDC Classic Administration Tasks
Setting Study/Site Security Privileges
Privileges in RDC Classic
Levels of Access in RDC Classic
Public Access in RDC Classic
Admin Privilege
Study Security Tasks
View Information for All Studies in a Database
View the Studies and Privileges Assigned to a User
Add a User to a Study
Modify Study Privileges for an Existing User
Determine the Sites in a Study
Access Site Security from Study Security
Setting Study Security for RDC Classic Users
Adding User Privileges for a Study
RDC Classic Site Security Tasks
Add a User to a Site
Modify Site Privileges for a User
Setting Site Security
Adding User Privileges for a Site Within a Study
Remove all Site-level Privileges for a User
Work with the RDC Classic Configurations Settings
Discussion
Configuration Name
Assignment Parameters
Configuration Management Tasks
Create a New Configuration
Modify the Assignment Parameters for a Configuration
Create a Copy of an Existing Configuration
Modify Configuration Settings
Delete a Configuration
RDC Classic Configurations Settings
Hide Task Tabs
Task Tab Header Text
Hide the Preferences Menu Choice Y/N
Hide Group Activities Menu Choice Y/N
Hide Surround Type Drop-down
CRF Progression Settings
Default Search Option
Oracle Clinical Accessibility Rules
Default Settings
19
Managing the Activity List
Discussion
Configure the Activity List for Use in RDC Classic Sessions
Interaction with the Summary Task Tab
Default Activities
Activity List Structure
Background Structure of the Activity List Window
Navigation Pane
Task Pane
Link Type
Activity Conditions
Activity Evaluation
System Processing
Example of Activity List Processing
Processing Activities
URL Activities
Procedure Activities
Tables Associated with the Activity List Window
RDC_ACTIVITIES Table
RDC_ACTIVITY_TAGS Table
RDC_ACTIVITY_COLUMN table
Views Associated with the Activity List Window
RDC_ACTIVITY_LIST View
RDC_USER_ACTIVITY_LIST View
Defining an Activity for the Activity List
Copy the Demo Packages
Edit rdc_activity_client_ps.sql
Edit rdc_activity_client_pb.sql
Create a new TAG for NUM_UNAPP
Create the Activity
Install the New Code and Insert the New TAG and Activity
Glossary
Index