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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 Clinical Documentation
• 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
  • Using Internet Explorer
    • Checking the Internet Explorer Settings
    • Configuring the Cache Settings for the Internet Explorer
  • Using iPad
  • 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
    • Patient Casebooks Pages
    • Review Pages
    • Reports Page
    • Source Data Verification Plan 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
  • 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 and CRFs
  • 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 Patient Casebooks and Discrepancies
• 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 Patient Casebooks Page
  • Single Patient View
    • Casebook Spreadsheet
  • Multiple Patient View
    • Navigating in the Multiple Patient Casebook Spreadsheet
    • Selecting a Visit for the Multi-Patient Casebook page
    • Displaying the Study Interval with the Visit Name in the multiple patient view
  • Clicking a CRF Icon to Enter or Update Data
  • Nonflexible and Flexible Clinical Studies
    • About Expected CRFs and Visits
    • How RDC Onsite Alerts You to Changes in Expected CRFs and Visits
• 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
  • Entering 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
• Generating a CRF Report or a CRF History Report
• 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 Patient 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 Performing Custom Reviews

• Finding CRFs to Perform Custom Reviews
  • Using a Customized Activities Link on the Home Page
  • Selecting Patients and Reviewing CRFs
• Finding CRFs that Require Re-review
• Reviewing CRFs from the Data Entry Window
  • Reviewing Data
  • Reviewing Discrepancies
  • Viewing Review History
  • Reviewing Changes Since Latest Review Complete
  • Reviewing Audit History
• Completing CRF Review from the Data Entry Window
• Group Update for Custom Review Status

8 Verifying CRFs

• Finding CRFs to Verify
  • Using a Customized Activities Link on the Home Page
  • Selecting Patient Casebooks or CRF Review Tabs Directly
• 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
• Verifying Deleted but Not Re-entered CRFs

9 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 Patient 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

10 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 a Custom Review 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

11 Viewing Summary Reports

• Viewing a Study and Site Summary Report
• Viewing a Patient Summary Report

12 Generating CRF Reports

• Working with the Reports Page
• CRF Report Content
  • Content of a Patient Data Report
    • Cover Page in a Patient Data Report
    • CRF Section
    • Ancillary Data Pages in a Patient Data Report
    • Bookmarks in a Patient Data Report
    • Page Numbering in a Patient Data Report
  • Content of a Blank Casebook Report
    • Cover Page in a Blank Casebook Report
    • CRF Data Section in a Blank Casebook Report
• Generating a Patient Data Report
  • 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 Patient Casebooks Page
    • Generating a Patient Data Report from the Review CRFs Page
    • Generating a Report from the Data Entry Window
  • Regenerating Forms Utility
    • PDR Results When DCI Forms Do Not Have Field Hyperlinks Enabled
    • Instructions for Regenerating DCI Forms to Enable Field Hyperlinks
    • Issue with Studies Having Many DCI Form Versions
• Generating a Blank Casebook Report
• Generating a Standalone Deleted CRFs 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

13 Using Source Data Verification

• Published, Draft, and Obsolete SDV Plan Versions
  • Updating a Published SDV Plan
  • Creating a New SDV Plan
• Patient Plan
  • Patient Plan Draft
  • Patient Plan Published
• Critical Forms Plan
  • Critical Forms Plan Draft
    • Review Exclusion Options
    • Select Critical Forms for SDV
    • Review the Current CRF SDV Selection Status
  • Critical Forms Plan Published
• Obsolete Plans
• Using 100% Source Data Verification
• Using Empty SDV Plans

A Description of the CRF Icons

• About the CRF Icons
• Data Entry Status Icons
• Discrepancy Status Icons
• Verification Status Icons
• Approval Status Icons
• Custom Review Status Icons
• Multiple-Status Icons
• Summary of Colors and Symbols Added to CRF Icons

B Patient Auto-Selection in Partial Source Data Verification

• SDV Patient Pools
• Auto-select Processing
• Patient Eligibility is Reversed
• All Data for a Patient is Deleted
• Patient SDV Plan is Updated
• Patient Transferred from One Site to Another
• Data Transferred from One Patient to Another
• Patient ID Is Updated in a CRF (Key Changes or Mass Key Changes)
• DCI or Other Date Is Updated in a CRF

Index