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 Entering Data

• Understanding the Data Entry Process
• DCI Structure
• Entering CRF Data in a DCI
  • Accessibility
  • Logging In CRF Header Information
    • Completing the Initial Log-In
    • If Your Header Information Fails to Validate
    • Completing the RDCM Window
    • Logging In DCMs
    • If You Cannot Complete All DCMs
  • First-Pass Data Entry
  • Initial Login and Data Entry
  • Validating Data Entry
    • Univariate Validation
    • System Responses to a Univariate Validation Failure
    • User Responses to a Univariate Validation Failure
    • Indicators of an Existing Discrepancy
    • Group and Form Validation
  • Second-Pass Data Entry
  • Reconciling Differences Between First- and Second-Pass Data
    • Resolving First-Pass/Second-Pass Comparison Failures
    • Resolving Duplicate or Missing Records
    • Performing Comparison Reconciliation
• Making Adjustments During Data Entry
  • Enrolling a Patient
  • Transferring Patient Data
  • Handling Unplanned Events
  • Changing Tasks
  • Reviewing the DCI History
    • Audit Trail Window
    • How the System Stores the Audit Trail
• Modifying DCIs
  • Process the Reason for Change Window
  • Changing Header Information
  • Updating Accessible Data
    • System Validations Performed During Update Mode
    • Performing a Privileged Update
  • Modifying or Deleting Locked RDCIs and RDCMs
    • To Modify Accessible RDCIs
    • To Delete Logged-in RDCIs
• Viewing Data
  • Scanned Image
  • Browse
  • Browse the Audit Trail

2 Customizing Data Entry Windows

• Sequencing Data Entry
  • Query Sequencing
  • DCI Book Sequencing
  • Using DCI Books
    • Completing DCIs from the DCI Book
    • Patient Enrollment
  • Tracking Page-Level Information
    • Oracle Clinical Management of Unplanned DCIs
    • Applying Page Statuses
    • Tracking Changes to a Page
• Navigation
  • Field Navigation
    • Normal Field Navigation
    • Auto Skip Navigation
    • Conditional Navigation
  • Other Navigation Features
    • Group Navigation
    • Display Received DCM Window
    • Exit/Autosequence Behavior
  • Comments Permitted in DCIs
    • Investigator Comments
    • Operator Comments
  • Physical Field Attributes
    • Color Indications on Data Entry Fields
    • Date and Time Field Formats
    • Using Long Fields
    • Modify Audit Comment
• Value-Setting Features
  • Default Values
    • Single Default Values
    • Repeating Default Values
    • Second-Pass Sight Verification
  • Lists of Values
    • Insert/Delete Record in a Question Group

3 Tracking DCMs

• About DCM Tracking
• How Oracle Clinical Tracks DCMs
  • The Study Schedule
  • How Optional Visits Interact with DCM Tracking
  • How Termination Visits Interact With DCM Tracking
• DCM Tracking Tools
  • Maintain Missing DCMs Window
  • DCM Detail Tracking Matrix Report
    • How to Use This Report
    • Report Parameters
    • Data Entry Statuses
    • RDCM Validation Statuses
    • Not-received DCM Statuses
  • Missing and Overdue DCMs Report
  • Investigator Corrections and Missing Pages Report

4 Using the Discrepancy Database

• About the Discrepancy Database
• Discrepancy Types
• Example: Using Discrepancies to Clean Data
• Using Batch Validation
  • Batch Validation Process
  • Locking Mechanism
  • Running Batch Validation
  • Running TMS Validation
  • Creating and Activating Resource Groups for Batch Validation
• Executing a single Procedure
• Using Profiles
  • Selecting a Profile
  • Refining Profile Criteria
  • Changing a Profile
    • Temporary Changes
    • Permanent Changes
  • Creating New Profiles
• Using the Maintain Discrepancy Database Window
  • Single-Record View
  • Multi-Record View
  • Maintain Discrepancy Database Window Fields
  • Changing Discrepancy Display Layout and Filtering the Data Displayed
    • Changing the Display of Discrepancy Information
    • Filtering Discrepancy Information
    • Changing the Filter Values
    • Querying Within the Filter Limitations
  • Viewing Univariate Discrepancies' Related Discrepancies
  • Viewing Multivariate Discrepancies' Responses
  • Viewing a Discrepancy's History
  • Viewing a Discrepancy's Internal Comment History
• Managing Discrepancies
  • Discrepancy Status Codes
    • System Status Code
    • Review Status Code
    • Resolution Status
    • Review Status Workflow Example
  • Browse and Update Patient Data
  • Entering Manual Discrepancies
  • Including CRF Page Numbers With Discrepancies
  • Maintaining Data Clarification Form (DCF) Information
  • Modifying Groups of Discrepancies
    • Selecting a Group of Records to Change
    • Choosing a Change Type
  • Group-Updating Review Status
  • Group-Updating CRF Page Numbers
  • Group-Inserting Standard Text
  • Group-Marking for Passive Review
  • Creating a DCF for a Hand-Selected Group of Discrepancies
• Using the Test Discrepancy Database

5 Using Data Clarification Forms

• Description of Fields
• Creating DCFs
  • Adding Multivariate Discrepancy's Procedure Variables to a DCF
• Adding, Removing, and Editing a DCF's Discrepancies
  • Adding a Discrepancy to a DCF
  • Removing a Discrepancy from a DCF
  • Editing Resolution and Comment Text
• Viewing DCF Details
• Maintaining DCF Discrepancy Query Details
• Tracking DCF Pages
• Setting the DCF Status
  • Changing the DCF Status from the Maintain DCFs Window
  • Changing the DCF Status When Printing the DCF Report
  • Changing the DCF Status by Changing DCF Page Statuses
• Printing DCFs
  • DCF Print Status
  • About the Parameter New DCF Status to Assign
  • Troubleshooting: Unable to Print DCF
    • Checking Owning User Account Through Oracle Clinical User Interface
    • Checking Owning User Account Using SQL
• Deleting DCFs

6 Making Mass Changes

• About Mass Changes
• Types of Mass Changes
• Defining a Mass Change Specification and Its Criteria
  • Defining the Mass Change Specification
    • Naming and Describing the MCS
    • Defining the Scope of the Records to be Changed
    • Saving the Mass Change Specification
  • Defining Candidate Data Set Criteria
    • CDS Criteria Examples
    • CDS Criteria Syntax
    • CDS Criteria Definition Rules
    • Counting CDS Records
  • Copying a Mass Change Specification
• Creating and Modifying the Candidate Data Set
  • Viewing the CDS
    • Rows
    • Columns
    • Status
  • Changing the Display and Processing Order
    • Example
    • To Reorder the Display and Processing Order:
  • Clearing a CDS
• Correcting Records
  • Making Mass Changes: Group Updating
    • Specifying Group Update Changes
    • Excluding Records from the Group Update
    • Running the Group Update on the CDS
    • Testing that the Changes Are Valid
    • Printing a Report of the CDS Changes
    • Viewing Group Update Histories
    • Applying the Changes to the Database
    • Soft-Deleting RDCIs
  • Changing Individual Records in the CDS
• Closing a Mass Change Specification

7 Batch Loading Data

• Setting Up for Batch Data Loading
  • Defining a Rollback Segment
  • Defining and Using Format Masks
    • STANDARD Mask Format
    • User-Specified Formats
    • Normalized Lab Data
• Batch Data Load Stages
  • Load
  • Prepare
  • Transfer
• Standard Batch Data Load and Out of Study Batch Data Load
• Using the Batch Data Loader
  • Preprocessing Data Files
    • Subevent Number Not Supplied
  • Creating and Viewing Data File Entries
    • Creating Data File Entries for Out of Study Batch Data Loads
    • Creating Data File Entries for Standard Batch Data Loads
  • Selecting Data Files
  • Loading Data
• Understanding the Error Log
• Batch Deleting Data
  • Auditing Data Deletion
• Batch Data Load Reports
  • Processed Data Report

8 Data Extract

• About Data Extract
• Data Extract Context
  • Default View Creation Algorithm
  • View Types
  • Rollsnaps
  • Access Accounts
    • Purging Study Access Accounts
  • Table-Based Views
  • Creating Extract Tables and Indexes
• Simple Workflow
  • Submit Views to PSUB
    • Full and Incremental Modes
  • Tasks in Conduct
  • Validation Status and Views
    • For Pre-3.1-Style Study Views
    • For View Builder Study Views
    • Rules for Setting Status Variables
  • Create View Accounts
  • Query Data Extract Views
  • SAS Datasets
  • SAS Proc Reports
• Data Extract View Loader
  • Loading External Views
  • File Format for Externally Loaded Views
    • Example 1: Oracle Format
    • Example 2: Oracle Format with Substitution Parameters
    • Example 3: SAS Format
  • Restrictions for Externally Loaded Views
  • Updating an Externally Loaded View
  • Deleting an Externally Loaded View

9 Security Settings for Study Conduct

• Freezing and Locking Data
  • About Freezing and Locking Data
  • Freezing Data
    • Freezing Data by Site, Investigator, or Patients
    • Freezing Data by Study
  • Checking Frozen Status
  • Unfreezing Studies, Study Sites, Investigators, and Patients
    • Unfreezing Sites, Investigators, and Patients
    • Unfreezing a Study
  • Locking Data
    • Batch-Locking Data
    • Manually Locking RDCIs and RDCMs
• Enabling and Disabling Pass 2 Required

10 Graphic Patient Data Reports

• Graphic Patient Data Report
  • Navigation and Format
  • Requirements
• Patient Data Report Components
  • 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
  • Extended Text Audit History Section
  • Audit History Report Section
  • Discrepancy Detail Report Section
  • Deleted CRFs Section
• Audit History Report

Index