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Contents

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

• 1.1 Understanding the Data Entry Process
• 1.2 DCI Structure
• 1.3 Entering CRF Data in a DCI
  • 1.3.1 Accessibility
  • 1.3.2 Logging In CRF Header Information
    • 1.3.2.1 Completing the Initial Log-In
    • 1.3.2.2 If Your Header Information Fails to Validate
    • 1.3.2.3 Completing the RDCM Window
    • 1.3.2.4 Logging In DCMs
    • 1.3.2.5 If You Cannot Complete All DCMs
  • 1.3.3 First-Pass Data Entry
  • 1.3.4 Initial Login and Data Entry
  • 1.3.5 Validating Data Entry
    • 1.3.5.1 Univariate Validation
    • 1.3.5.2 System Responses to a Univariate Validation Failure
    • 1.3.5.3 User Responses to a Univariate Validation Failure
    • 1.3.5.4 Indicators of an Existing Discrepancy
    • 1.3.5.5 Group and Form Validation
  • 1.3.6 Second-Pass Data Entry
  • 1.3.7 Reconciling Differences Between First- and Second-Pass Data
    • 1.3.7.1 Resolving First-Pass/Second-Pass Comparison Failures
    • 1.3.7.2 Resolving Duplicate or Missing Records
    • 1.3.7.3 Performing Comparison Reconciliation
• 1.4 Making Adjustments During Data Entry
  • 1.4.1 Enrolling a Patient
  • 1.4.2 Transferring Patient Data
  • 1.4.3 Handling Unplanned Events
  • 1.4.4 Changing Tasks
  • 1.4.5 Reviewing the DCI History
    • 1.4.5.1 Audit Trail Window
    • 1.4.5.2 How the System Stores the Audit Trail
• 1.5 Modifying DCIs
  • 1.5.1 Process the Reason for Change Window
  • 1.5.2 Changing Header Information
  • 1.5.3 Updating Accessible Data
    • 1.5.3.1 System Validations Performed During Update Mode
    • 1.5.3.2 Performing a Privileged Update
  • 1.5.4 Modifying or Deleting Locked RDCIs and RDCMs
    • 1.5.4.1 To Modify Accessible RDCIs
    • 1.5.4.2 To Delete Logged-in RDCIs
• 1.6 Viewing Data
  • 1.6.1 Scanned Image
  • 1.6.2 Browse
  • 1.6.3 Browse the Audit Trail

2 Customizing Data Entry Windows

• 2.1 Sequencing Data Entry
  • 2.1.1 Query Sequencing
  • 2.1.2 DCI Book Sequencing
  • 2.1.3 Using DCI Books
    • 2.1.3.1 Completing DCIs from the DCI Book
      • 2.1.3.1.1 Autosequencing Through DCI Books
      • 2.1.3.1.2 Manually Stepping Through DCI Books
    • 2.1.3.2 Patient Enrollment
  • 2.1.4 Tracking Page-Level Information
    • 2.1.4.1 Oracle Clinical Management of Unplanned DCIs
      • 2.1.4.1.1 Unplanned Scenarios:
    • 2.1.4.2 Applying Page Statuses
    • 2.1.4.3 Tracking Changes to a Page
• 2.2 Navigation
  • 2.2.1 Field Navigation
    • 2.2.1.1 Normal Field Navigation
    • 2.2.1.2 Auto Skip Navigation
    • 2.2.1.3 Conditional Navigation
  • 2.2.2 Other Navigation Features
    • 2.2.2.1 Group Navigation
    • 2.2.2.2 Display Received DCM Window
    • 2.2.2.3 Exit/Autosequence Behavior
  • 2.2.3 Comments Permitted in DCIs
    • 2.2.3.1 Investigator Comments
    • 2.2.3.2 Operator Comments
  • 2.2.4 Physical Field Attributes
    • 2.2.4.1 Color Indications on Data Entry Fields
    • 2.2.4.2 Date and Time Field Formats
    • 2.2.4.3 Using Long Fields
    • 2.2.4.4 Modify Audit Comment
• 2.3 Value-Setting Features
  • 2.3.1 Default Values
    • 2.3.1.1 Single Default Values
    • 2.3.1.2 Repeating Default Values
    • 2.3.1.3 Second-Pass Sight Verification
  • 2.3.2 Lists of Values
    • 2.3.2.1 Insert/Delete Record in a Question Group

3 Tracking DCMs

• 3.1 About DCM Tracking
• 3.2 How Oracle Clinical Tracks DCMs
  • 3.2.1 The Study Schedule
  • 3.2.2 How Optional Visits Interact with DCM Tracking
  • 3.2.3 How Termination Visits Interact With DCM Tracking
• 3.3 DCM Tracking Tools
  • 3.3.1 Maintain Missing DCMs Window
  • 3.3.2 DCM Detail Tracking Matrix Report
    • 3.3.2.1 How to Use This Report
    • 3.3.2.2 Report Parameters
    • 3.3.2.3 Data Entry Statuses
    • 3.3.2.4 RDCM Validation Statuses
    • 3.3.2.5 Not-received DCM Statuses
  • 3.3.3 Missing and Overdue DCMs Report
  • 3.3.4 Investigator Corrections and Missing Pages Report

4 Using the Discrepancy Database

• 4.1 About the Discrepancy Database
• 4.2 Discrepancy Types
• 4.3 Example: Using Discrepancies to Clean Data
• 4.4 Using Batch Validation
  • 4.4.1 Batch Validation Process
  • 4.4.2 Locking Mechanism
  • 4.4.3 Running Batch Validation
  • 4.4.4 Running TMS Validation
  • 4.4.5 Creating and Activating Resource Groups for Batch Validation
• 4.5 Executing a single Procedure
• 4.6 Using Profiles
  • 4.6.1 Selecting a Profile
  • 4.6.2 Refining Profile Criteria
  • 4.6.3 Changing a Profile
    • 4.6.3.1 Temporary Changes
    • 4.6.3.2 Permanent Changes
  • 4.6.4 Creating New Profiles
• 4.7 Using the Maintain Discrepancy Database Window
  • 4.7.1 Single-Record View
  • 4.7.2 Multi-Record View
  • 4.7.3 Maintain Discrepancy Database Window Fields
  • 4.7.4 Changing Discrepancy Display Layout and Filtering the Data Displayed
    • 4.7.4.1 Changing the Display of Discrepancy Information
    • 4.7.4.2 Filtering Discrepancy Information
    • 4.7.4.3 Changing the Filter Values
    • 4.7.4.4 Querying Within the Filter Limitations
  • 4.7.5 Viewing Univariate Discrepancies' Related Discrepancies
  • 4.7.6 Viewing Multivariate Discrepancies' Responses
  • 4.7.7 Viewing a Discrepancy's History
  • 4.7.8 Viewing a Discrepancy's Internal Comment History
• 4.8 Managing Discrepancies
  • 4.8.1 Discrepancy Status Codes
    • 4.8.1.1 System Status Code
    • 4.8.1.2 Review Status Code
    • 4.8.1.3 Resolution Status
    • 4.8.1.4 Review Status Workflow Example
  • 4.8.2 Browse and Update Patient Data
  • 4.8.3 Entering Manual Discrepancies
  • 4.8.4 Including CRF Page Numbers With Discrepancies
  • 4.8.5 Maintaining Data Clarification Form (DCF) Information
  • 4.8.6 Modifying Groups of Discrepancies
    • 4.8.6.1 Selecting a Group of Records to Change
    • 4.8.6.2 Choosing a Change Type
  • 4.8.7 Group-Updating Review Status
  • 4.8.8 Group-Updating CRF Page Numbers
  • 4.8.9 Group-Inserting Standard Text
  • 4.8.10 Group-Marking for Passive Review
  • 4.8.11 Creating a DCF for a Hand-Selected Group of Discrepancies
• 4.9 Using the Test Discrepancy Database

5 Using Data Clarification Forms

• 5.1 Description of Fields
• 5.2 Creating DCFs
  • 5.2.1 Adding Multivariate Discrepancy's Procedure Variables to a DCF
• 5.3 Adding, Removing, and Editing a DCF's Discrepancies
  • 5.3.1 Adding a Discrepancy to a DCF
  • 5.3.2 Removing a Discrepancy from a DCF
  • 5.3.3 Editing Resolution and Comment Text
• 5.4 Viewing DCF Details
• 5.5 Maintaining DCF Discrepancy Query Details
• 5.6 Tracking DCF Pages
• 5.7 Setting the DCF Status
  • 5.7.1 Changing the DCF Status from the Maintain DCFs Window
  • 5.7.2 Changing the DCF Status When Printing the DCF Report
  • 5.7.3 Changing the DCF Status by Changing DCF Page Statuses
• 5.8 Printing DCFs
  • 5.8.1 DCF Print Status
  • 5.8.2 About the Parameter New DCF Status to Assign
  • 5.8.3 Troubleshooting: Unable to Print DCF
    • 5.8.3.1 Checking Owning User Account Through Oracle Clinical User Interface
    • 5.8.3.2 Checking Owning User Account Using SQL
• 5.9 Deleting DCFs

6 Making Mass Changes

• 6.1 About Mass Changes
• 6.2 Types of Mass Changes
• 6.3 Defining a Mass Change Specification and Its Criteria
  • 6.3.1 Defining the Mass Change Specification
    • 6.3.1.1 Naming and Describing the MCS
    • 6.3.1.2 Defining the Scope of the Records to be Changed
    • 6.3.1.3 Saving the Mass Change Specification
  • 6.3.2 Defining Candidate Data Set Criteria
    • 6.3.2.1 CDS Criteria Examples
    • 6.3.2.2 CDS Criteria Syntax
    • 6.3.2.3 CDS Criteria Definition Rules
    • 6.3.2.4 Counting CDS Records
  • 6.3.3 Copying a Mass Change Specification
• 6.4 Creating and Modifying the Candidate Data Set
  • 6.4.1 Viewing the CDS
    • 6.4.1.1 Rows
    • 6.4.1.2 Columns
    • 6.4.1.3 Status
  • 6.4.2 Changing the Display and Processing Order
    • 6.4.2.1 Example
    • 6.4.2.2 To Reorder the Display and Processing Order:
  • 6.4.3 Clearing a CDS
• 6.5 Correcting Records
  • 6.5.1 Making Mass Changes: Group Updating
    • 6.5.1.1 Specifying Group Update Changes
    • 6.5.1.2 Excluding Records from the Group Update
    • 6.5.1.3 Running the Group Update on the CDS
    • 6.5.1.4 Testing that the Changes Are Valid
    • 6.5.1.5 Printing a Report of the CDS Changes
    • 6.5.1.6 Viewing Group Update Histories
    • 6.5.1.7 Applying the Changes to the Database
    • 6.5.1.8 Soft-Deleting RDCIs
  • 6.5.2 Changing Individual Records in the CDS
• 6.6 Closing a Mass Change Specification

7 Batch Loading Data

• 7.1 Setting Up for Batch Data Loading
  • 7.1.1 Defining a Rollback Segment
  • 7.1.2 Defining and Using Format Masks
    • 7.1.2.1 STANDARD Mask Format
    • 7.1.2.2 User-Specified Formats
    • 7.1.2.3 Normalized Lab Data
• 7.2 Batch Data Load Stages
  • 7.2.1 Load
  • 7.2.2 Prepare
  • 7.2.3 Transfer
• 7.3 Standard Batch Data Load and Out of Study Batch Data Load
• 7.4 Using the Batch Data Loader
  • 7.4.1 Preprocessing Data Files
    • 7.4.1.1 Subevent Number Not Supplied
  • 7.4.2 Creating and Viewing Data File Entries
    • 7.4.2.1 Creating Data File Entries for Out of Study Batch Data Loads
    • 7.4.2.2 Creating Data File Entries for Standard Batch Data Loads
  • 7.4.3 Selecting Data Files
  • 7.4.4 Loading Data
• 7.5 Understanding the Error Log
• 7.6 Batch-Deleting Data
  • 7.6.1 Auditing Data Deletion
    • 7.6.1.1 Data File Tables
    • 7.6.1.2 Data Tables
    • 7.6.1.3 Definition Tables
    • 7.6.1.4 Layout Tables
    • 7.6.1.5 Other Reference Tables
  • 7.6.2 Reports on Audited Data Deletion
• 7.7 Batch Data Load Reports
  • 7.7.1 Processed Data Report

8 Data Extract

• 8.1 About Data Extract
• 8.2 Data Extract Context
  • 8.2.1 Default View Creation Algorithm
  • 8.2.2 View Types
  • 8.2.3 Rollsnaps
  • 8.2.4 Access Accounts
    • 8.2.4.1 Purging Study Access Accounts
  • 8.2.5 Table-Based Views
  • 8.2.6 Creating Extract Tables and Indexes
• 8.3 Workflow
  • 8.3.1 Submit Views to PSUB
    • 8.3.1.1 Creating SAS Views on Windows when SAS and Oracle Clinical are on Different Computers
  • 8.3.2 Creating SAS Views on UNIX when SAS and Oracle Clinical are on Different Computers
    • 8.3.2.1 Run the SAS Job Manually
    • 8.3.2.2 Run the SAS Job Automatically
    • 8.3.2.3 Configure Reference Codelist Values
  • 8.3.3 Full and Incremental Modes
  • 8.3.4 Tasks in Conduct
  • 8.3.5 Validation Status and Views
    • 8.3.5.1 For Pre-3.1-Style Study Views
    • 8.3.5.2 For View Builder Study Views
    • 8.3.5.3 Rules for Setting Status Variables
      • 8.3.5.3.1 O - Outstanding
      • 8.3.5.3.2 I - Irresolvable
      • 8.3.5.3.3 K - Confirmed
      • 8.3.5.3.4 C - Clean
      • 8.3.5.3.5 N - None
  • 8.3.6 Create View Accounts
  • 8.3.7 Query Data Extract Views
  • 8.3.8 SAS Datasets
  • 8.3.9 SAS Proc Reports
• 8.4 Data Extract View Loader
  • 8.4.1 Loading External Views
  • 8.4.2 File Format for Externally Loaded Views
    • 8.4.2.1 Example 1: Oracle Format
    • 8.4.2.2 Example 2: Oracle Format with Substitution Parameters
    • 8.4.2.3 Example 3: SAS Format
  • 8.4.3 Restrictions for Externally Loaded Views
  • 8.4.4 Updating an Externally Loaded View
  • 8.4.5 Deleting an Externally Loaded View

9 Security Settings for Study Conduct

• 9.1 Freezing and Locking Data
  • 9.1.1 About Freezing and Locking Data
  • 9.1.2 Freezing Data
    • 9.1.2.1 Freezing Data by Site, Investigator, or Patients
    • 9.1.2.2 Freezing Data by Study
  • 9.1.3 Checking Frozen Status
  • 9.1.4 Unfreezing Studies, Study Sites, Investigators, and Patients
    • 9.1.4.1 Unfreezing Sites, Investigators, and Patients
    • 9.1.4.2 Unfreezing a Study
  • 9.1.5 Locking Data
    • 9.1.5.1 Batch-Locking Data
    • 9.1.5.2 Manually Locking RDCIs and RDCMs
• 9.2 Enabling and Disabling Pass 2 Required
• 9.3 Publish Source Data Verification Plans for All Sites
• 9.4 Execute Pending Patient Updates

10 Reports

• 10.1 Graphic Patient Data Report
  • 10.1.1 Navigation and Format
  • 10.1.2 Requirements
• 10.2 Patient Data Report Components
  • 10.2.1 Page Numbering
  • 10.2.2 Cover Page
    • 10.2.2.1 Blank Workbook PDRs
    • 10.2.2.2 Patient CRF PDRs
  • 10.2.3 CRF Data Section
    • 10.2.3.1 CRF Header Information
    • 10.2.3.2 CRF Section Header Information
    • 10.2.3.3 Response Data
  • 10.2.4 Ancillary Data Section
    • 10.2.4.1 CRF Creation
    • 10.2.4.2 Approval Notice
    • 10.2.4.3 End Notes
    • 10.2.4.4 Extended Text
      • 10.2.4.4.1 Extended Text Response Display
      • 10.2.4.4.2 Extended Text Audit History Section
    • 10.2.4.5 Deleted CRFs
• 10.3 Audit History Report
• 10.4 Verification and Approval History Report

Index