Table of Contents

• Title and Copyright Information
• Preface
  • Documentation accessibility
  • Related resources
  • Diversity and Inclusion
  • Access to Oracle Support
• 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
      • Completing DCIs from the DCI Book
      • Patient Enrollment
    • Using DCI Books
    • 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
  • 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
      • Loading Data into Derived Question Fields
    • 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
  • Troubleshooting Batch Validation
    • Troubleshooting the Prepare Phase
    • Troubleshooting the Transfer Phase
  • Batch-Deleting Data
    • Auditing Data Deletion
      • Data File Tables
      • Data Tables
      • Definition Tables
      • Layout Tables
      • Other Reference Tables
    • Reports on Audited Data Deletion
  • Batch Data Load Reports
• 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
  • Workflow
    • Submit Views to PSUB
      • Creating SAS Views on Windows when SAS and Oracle Clinical are on Different Computers
    • Creating SAS Views on UNIX when SAS and Oracle Clinical are on Different Computers
      • Run the SAS Job Manually
      • Run the SAS Job Automatically
      • Configure Reference Codelist Values
    • 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
  • Publish Source Data Verification Plans for All Sites
  • Execute Pending Patient Updates
• 10 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
      • Response Data
    • Ancillary Data Section
      • CRF Creation
      • Approval Notice
      • End Notes
      • Extended Text
      • Deleted CRFs
  • Audit History Report
  • Verification and Approval History Report