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Oracle® Clinical Remote Data Capture Onsite User's Guide
Release 4.6.2
Part Number E18822-01
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Contents
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 Remote Data Capture Onsite
About Electronic Data Capture
Terminology to Know and Understand
About RDC Onsite User Roles
Starting the RDC Onsite Application
Requirements for Running the RDC Onsite Application
Checking the Internet Explorer Settings
Configuring the Cache Settings for the Internet Explorer
Logging In to RDC Onsite
Shortcut to the Login Page
Custom Options for the Login Page
Resetting a Forgotten Password
Starting at the Home Page
About the Main Pages
Home Page
Casebooks Page
Review Pages
Reports Page
About the Session Information
About Last Refresh
When a Session Times Out
About the Global Links
Changing Your RDC Onsite Login Password
Custom Options for the Change Password Link
Expiration Date for Your RDC Onsite Login Password
Setting Your Preferences for Lists and Dates
Restoring the Default Values for Preferences
Getting Help and Assistance
Using the Online Help System
Navigating from Help Topic to Topic
Searching for Topics in the Online Help
Using Links to Navigate within the Online Help
Creating Shortcuts and Adding Favorites for Help Topics
Viewing CRF and Field Help Customized by Your Sponsor
Getting Tips about Tools
Viewing Release and Configuration Information about RDC Onsite
Contacting Your Help Desk
Logging Out
2
Learning the Common Tools
Selecting Your Current Study and Site
Available Studies and Sites
Your Current Study and Site
Summary Report of the Current Study and Site
Using the Patient Selection List on the Home Page
Selecting Patients
Selecting Your Task
Sorting the Entries in a List
Examples of Sorting Columns
Sorting to Find Available Patient Numbers
Sorting to Find Patients with Recently Modified Data
Sorting to Find Patients by Casebook
Unique Sort on the Patient Number
Navigating from Page to Page
Using the Page Tabs
Drilling Down and Using Breadcrumbs
Visual Clues of Drilling Down
Drill-down Return: Breadcrumb versus Page Tab
Example: Drilling Down to Casebooks and Discrepancies
Navigating through Long Lists
Searching for Patients or CRFs
Working with Customized News, Activities, and Links
Using the News, Activities, and Links Sections Effectively
Reading the Daily News
Taking a Shortcut to Your Activities
Following Your Activities Trail
Using the Default Activities Links
Using Customized Shortcuts to Relevant Web Sites
Viewing a Summary Report for a Patient
3
Entering and Updating Patient Data
Starting Data Entry for Patients in a Clinical Study
Selecting Your Current Study and Site
Finding Patients for Data Entry
Selecting the Next Available Patient Number
Filtering the Patients List to Find Unused Patient Numbers
Finding Particular Patient Numbers
Opening the Patient Casebooks
Selecting a Patient CRF for Data Entry
Using the Casebooks Page
Nonflexible and Flexible Clinical Studies
About Expected CRFs and Visits
How RDC Onsite Alerts You to Changes in Expected CRFs and Visits
Selecting a Visit for the Casebook Spreadsheet
Selecting a Visit for Flexible Studies
Selecting a Visit for Nonflexible Studies
Displaying the Study Interval with the Visit Name
Navigating in the Casebook Spreadsheet
About the CRF Icons
Clicking a CRF to Enter or Update Data
Using the Data Entry Window
Navigating in the Data Entry Window
Navigating from Field to Field
Navigating within the CRF
Navigating from CRF to CRF
Navigation in a CRF with Hidden or Grayed Out Questions
About Conditional Questions
Visual Appearance of Conditional Questions
Automatic Field Navigation and Activation
Using the Toolbar Icons in the Data Entry Window
Highlighting Fields in a CRF
Entering Data in a CRF
Standard Text Fields versus Extended Text Fields
Yellow Note Icon Indicates an Extended Text Field in the CRF
ATTACHMENT Prefix Indicates Extended Text Fields
Entering Data in a Standard Text Field
Displaying the Full Text of a Standard Text Field
Entering Data in an Extended Text Field
Opening the Show Extended Text Dialog Box
Viewing or Entering Data in an Extended Text Field
Keys for Entering Data in the Show Extended Text Dialog Box
Using Special Characters and Advanced Formatting in Extended Text Fields
Selecting Data from a List of Acceptable Values
Using the Calendar to Enter Dates
Processing Validation Errors During Initial Data Entry
Adding and Updating an Investigator Comment
Changing Your Preferences for Data Entry
Viewing CRF and Field Help Customized by Your Sponsor
Updating Existing Data in a CRF
Specifying the Reason for Changing a Data Value
Processing Validation Errors During Data Update
Revising Discrepant Data
Allowing Discrepant Data
Saving a CRF
User Initiated Save
Save Complete
Save Incomplete
About Missing Required Header Fields
RDC Onsite Prompts for Saving Edits
Effects of Discarding Changes
Save and Automatic Refresh
Changing CRF Status from Saved Incomplete
Removing Data from a CRF
Marking a CRF or CRF Section as Blank
Clicking the Blank Flag Icon
Selecting the Blank Flag Check Box in the CRF
Changing Between Blank and Non-blank Status
Deleting a Row from a Repeating Question Group
Deleting a CRF
Printing a CRF
Configuring Page Setup Before Printing a CRF
Opening and Printing a CRF from the Data Entry Window
Viewing the Audit History of a CRF Field
Audit History for Extended Text Fields
Using the Navigator Pane for Discrepancies and Investigator Comments
Opening, Closing, and Resizing the Navigator Pane
Selecting a Navigator Tab
Working with the List Pane and the Details Pane
Adding Pages
Adding an Unplanned Visit Page
Adding An Other Page
Validating Patient Data
4
Managing Discrepancies
Understanding Discrepancies and the Management Process
Types of Discrepancies
System-Generated Discrepancies
Univariate Discrepancies
Multivariate Discrepancies
Manual Discrepancies
Manual Field Discrepancies
Manual Section Discrepancies
Internal Manual Section Discrepancies
Discrepancy Status
Active and Other Discrepancies
Hidden Discrepancies
Closed Discrepancies
Colors Indicate Discrepancy Status
Finding CRFs with Discrepancies
Specifying Discrepancy Search Criteria
Using a Discrepancies Activities Link
Letting Color Guide You to Discrepancies
Reviewing Discrepancies
Working with the Review Discrepancies Page
Navigating to the Review Discrepancies Page
Sorting Discrepancies
Viewing the Details of a Discrepancy
Discrepancies and Extended Text Fields
Using the Casebooks Page to Review Discrepancies
Using a Filtered Casebook Spreadsheet View
Using a Non-filtered Casebook Spreadsheet View
Using the Review CRFs Page to Review Discrepancies
Resolving and Routing Discrepancies
Highlighting the Discrepancies in a CRF
Reviewing Discrepancies in the Navigator Pane
Opening, Closing, and Resizing the Navigator Pane
Showing and Selecting Discrepancies in the Navigator Pane
Reviewing Discrepancy Information in the Details Pane
Viewing the History of a Discrepancy
Viewing Related Values for Multivariate Discrepancies
Reviewing the Audit History for a Discrepancy
Updating Discrepancy Comments
Taking Action on Discrepancies
Types of Discrepancy Actions
Acting on Active versus Other Discrepancies
Routing Discrepancies
Resolving Discrepancies
Creating and Routing Manual Discrepancies
5
Reviewing Investigator Comments
Working with the Review Investigator Comments Page
Navigating to the Review Investigator Comments Page
Accessing the Review Investigator Comments Page Directly
Using a Custom Activities Link
Drilling Down to the Review Investigator Comments Page
Tools for Reviewing Investigator Comments
Reviewing Investigator Comments from the Data Entry Window
Using Highlighting to Identify Fields with Investigator Comments
Using the Navigator Pane to Display and Update Investigator Comments
Updating Investigator Comments
Viewing the History of an Investigator Comment
Adding and Updating an Investigator Comment
6
Reviewing Special Listings
About Special Listings
About the Review Special Listings Page
Displaying a Special Listing
7
Verifying CRFs
Finding CRFs to Verify
Using a Customized Activities Link on the Home Page
Selecting Patients and Navigating to the Review CRFs Page
Selecting Patients and Navigating to the Casebooks Page
Finding CRFs Requiring Re-verification
Reviewing CRFs from the Data Entry Window
Reviewing Data
Reviewing Discrepancies
Reviewing Verification History
Reviewing Changes since Latest Verification
Reviewing Audit History
Verifying CRFs from the Data Entry Window
Redoing CRF Verification
Verifying Multiple CRFs
Undoing Verification of Multiple CRFs
8
Approving CRFs
Finding CRFs for Approval
Using a Customized Activities Link on the Home Page
Selecting Patients and Navigating to the Review CRFs Page
Selecting Patients and Navigating to the Casebooks Page
Finding CRFs Requiring Re-Approval
Reviewing CRFs from the Data Entry Window
Reviewing Data
Reviewing Discrepancies
Reviewing Approval History
Reviewing Changes since Latest Approval
Reviewing Audit History
Approving CRFs from the Data Entry Window
Redoing CRF Approval
Approving Multiple CRFs
Undoing Approval of Multiple CRFs
About the Approve CRFs Dialog Box
9
Using Search
Selecting the Study and Site Context for a Search
Using the Search Pane
Using Patient Search Criteria
Searching for Patients by Number
Searching for Patients by Assigned Book
Searching for Patients by Data Entered
CRF Search Criteria and the Show Search Parameter
Hidden CRFs and the Show Search Parameter
Searching for Patients by the Patient Discrepancy Status
Searching on the Custom
Reference
Field
Using CRF Status Search Criteria
Searching by CRF Entry Status
Searching by CRF Discrepancy Status
Searching by CRF Approval Status
Searching by CRF Verification Status
Using CRF Source Search Criteria
Searching by CRF Source Casebook
Searching by CRF Source Visit
Searching by CRF Source CRF Name
Using Search Criteria During a Drill-down
About the Effects of an Inherited Patient Selection
About the Effects of an Inherited CRF Selection
About the Effects of an Inherited Discrepancy Status Selection
Clearing Your Search Criteria
10
Viewing Summary Reports
Viewing a Study and Site Summary Report
Viewing a Patient Summary Report
11
Generating CRF Reports
Working with the Reports Page
Generating a Patient Data Report from the Reports Page
Alternate Ways to Generate a Patient Data Report
Generating a Patient Data Report from the Home or Casebooks Page
Generating a Patient Data Report from the Review CRFs Page
Generating a Blank Casebook Report
Searching for Report Jobs
Monitoring the Status and Progress of Your Report Jobs
Stopping a Report Job in Progress
Viewing the Details of a Report Job
Printing a Report
A
Description of the CRF Icons
Data Entry Status Icons
Discrepancy Status Icons
Verification Status Icons
Approval Status Icons
Multiple-Status Icons
Summary of Colors and Symbols Added to CRF Icons
B
Report Contents
Content of a Patient Data Report
Cover Page in a Patient Data Report
CRF Superscripts in a Patient Data Report
Ancillary Data Pages in a Patient Data Report
CRF Created Information
Approval Information
Including Audit History and Discrepancy Details
Audit History Includes All Fields Even if Never Updated
Inserted and Deleted Rows
Bookmarks in a Patient Data Report
Appendices in a Patient Data Report
Page Numbering in a Patient Data Report
Extended Text Fields in Patient Data Reports
Content of a Blank Casebook Report
Cover Page in a Blank Casebook Report
CRF Data Section in a Blank Casebook Report
Page Numbering in a Blank Casebook Report
About the List of Unprinted DCIs
Index