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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 Overview of Creating a Study

• 1.1 Global Library
• 1.2 Design
  • 1.2.1 Easy Study Design
  • 1.2.2 Standard Design
    • 1.2.2.1 Planning
    • 1.2.2.2 Clinical Study
    • 1.2.2.3 Clinical Study Versions
    • 1.2.2.4 Planned Study Intervals
    • 1.2.2.5 Clinical Planned Events and Clinical Processes
    • 1.2.2.6 Treatment Patterns
    • 1.2.2.7 Patient Positions
    • 1.2.2.8 Blinding
    • 1.2.2.9 Stratification
    • 1.2.2.10 Randomization
• 1.3 Definition
  • 1.3.1 Definition Components
    • 1.3.1.1 Data Collection Modules
    • 1.3.1.2 Data Collection Instruments
    • 1.3.1.3 DCI Books
    • 1.3.1.4 CRF Page Tracking
    • 1.3.1.5 Procedures
    • 1.3.1.6 Validation Procedures
    • 1.3.1.7 Derivation Procedures
    • 1.3.1.8 Labs
    • 1.3.1.9 Data Extract
  • 1.3.2 Data Entry and Report Layout Design
    • 1.3.2.1 Character-Based Layouts
    • 1.3.2.2 Graphic Layouts

Part I Designing Studies

2 Planning and Designing a Study

• 2.1 Maintaining Programs
• 2.2 Defining Projects
• 2.3 Assigning Compounds
• 2.4 Creating Organization Units
• 2.5 Maintaining Regions
  • 2.5.1 Deleting a Region
  • 2.5.2 Updating a Region
  • 2.5.3 Maintaining Region Components
    • 2.5.3.1 Maintaining Parent Regions
    • 2.5.3.2 Maintaining Child Regions
• 2.6 Creating Planned Studies
• 2.7 Creating a Clinical Study
  • 2.7.1 Maintaining Clinical Study Objectives
  • 2.7.2 Maintaining Enrollment Criteria
  • 2.7.3 Maintaining Study Termination Criteria
  • 2.7.4 Creating Clinical Study Comments
  • 2.7.5 Assigning Clinical Study Regions
  • 2.7.6 Maintaining a Clinical Study's Historical Events
  • 2.7.7 Reviewing Planning Details
  • 2.7.8 Updating Clinical Study Statuses
  • 2.7.9 Deleting a Clinical Study
• 2.8 Designing Response-Dependent Branching
• 2.9 Setting Up Partial Source Data Verification
• 2.10 Designing a Flexible Study
  • 2.10.1 Enabling Flexible Study Functionality
  • 2.10.2 Defining Intervals and CPEs for Flexible Studies
  • 2.10.3 Using a Single DCI Book
  • 2.10.4 Using Rules
    • 2.10.4.1 Rule Triggers
      • 2.10.4.1.1 Using Derivation Procedures
      • 2.10.4.1.2 Using the Any Data Trigger
    • 2.10.4.2 Rule Targets
      • 2.10.4.2.1 DCI Rules
      • 2.10.4.2.2 Interval Rules
• 2.11 Using Oracle Clinical-Siebel Clinical Integration
• 2.12 Copying Clinical Studies
  • 2.12.1 Replicating Clinical Studies
  • 2.12.2 Creating Study Versions
    • 2.12.2.1 Copy Logic for Clinical Study Versions
• 2.13 Planning Study and Site Enrollment
• 2.14 Creating a New Study Plan
• 2.15 Study Site Plans
• 2.16 Maintaining Clinical Study States

3 Easy Study Design

• 3.1 Overview of Easy Study Design
  • 3.1.1 Using Easy Study Design
  • 3.1.2 Data Structure Compatibility
  • 3.1.3 Querying a Study
• 3.2 Creating a Clinical Study in the Easy Study Design Window
  • 3.2.1 Planning Study Intervals
    • 3.2.1.1 Creating Periods
    • 3.2.1.2 Resequencing Periods
    • 3.2.1.3 Creating Sub-periods
    • 3.2.1.4 Resequencing Sub-periods
  • 3.2.2 Defining Clinical Planned Events
  • 3.2.3 Defining Treatment Patterns
  • 3.2.4 Creating Patient Positions
    • 3.2.4.1 Displaying Patient Positions
    • 3.2.4.2 Deleting Patient Positions
• 3.3 Completing Easy Study Design

4 Sites, Investigators, and Patient Positions

• 4.1 Maintaining Site Records
  • 4.1.1 Creating Site Records
  • 4.1.2 Assigning Sites to a Study
• 4.2 Maintaining Investigator Records
  • 4.2.1 Creating Investigator Records
  • 4.2.2 Assigning Investigators to Study Sites
• 4.3 Maintaining Patient Positions
  • 4.3.1 Creating Patient Positions
    • 4.3.1.1 Creating Patient Positions with System-Generated Codes
    • 4.3.1.2 Creating Patient Positions with User-Defined Codes
  • 4.3.2 Marking Patients Eligible for Source Data Verification
    • 4.3.2.1 Manual Set Up
    • 4.3.2.2 Validation Procedure
    • 4.3.2.3 Batch Load Job
      • 4.3.2.3.1 Patient SDV File
      • 4.3.2.3.2 Processing
    • 4.3.2.4 Introducing a Patient SDV Plan in an Ongoing Study
  • 4.3.3 Assigning Patient Positions to Sites
    • 4.3.3.1 Assigning Patient Positions from the Study Sites Window
    • 4.3.3.2 Assigning Patient Positions from the Patient Positions Window
    • 4.3.3.3 Assigning Patient Positions by Range
    • 4.3.3.4 Assigning New Blocks of Patient Positions
  • 4.3.4 Changing Owning Locations
  • 4.3.5 Retrieving Patient Positions
  • 4.3.6 Deleting Patient Positions
    • 4.3.6.1 Deleting System-Generated Patient Positions
    • 4.3.6.2 Deleting Alpha Code Patient Positions
  • 4.3.7 Enrolling Patients in a Study
    • 4.3.7.1 Adding Patient Position Details
    • 4.3.7.2 Batch Load Patient Enrollment Dates
  • 4.3.8 Linking Patient Positions in Different Studies
  • 4.3.9 Assigning Patient Positions to DCI Books
    • 4.3.9.1 Assigning Patient Positions by Range
    • 4.3.9.2 Assigning Patient Positions by Site
    • 4.3.9.3 Assigning Patient Positions by Study
• 4.4 Treatment Assignments
  • 4.4.1 Assigning Selected Treatment Assignments to a Site
  • 4.4.2 Linking Treatment Assignments
    • 4.4.2.1 Linking Treatment Assignments by Range
    • 4.4.2.2 Linking Treatment Assignment Ranges to a Site
• 4.5 Blind Breaks
  • 4.5.1 Creating, Reviewing, or Canceling Blind Breaks

5 Treatments and Schedules

• 5.1 Treatments
  • 5.1.1 Maintaining Active Substances
  • 5.1.2 Maintaining Drugs
  • 5.1.3 Maintaining Single Treatment Regimens
  • 5.1.4 Creating or Modifying a Single Treatment Regimen
    • 5.1.4.1 Specifying Dosage by Range
    • 5.1.4.2 Maintaining Non-linear Titration Steps for a Treatment Regimen
  • 5.1.5 Maintaining Daily Dosage Details for a Treatment Regimen
    • 5.1.5.1 Changing the Drug Assigned to a Treatment Regimen
  • 5.1.6 Maintaining Combined Treatment Regimens
    • 5.1.6.1 Creating a New Combined Treatment Regimen
    • 5.1.6.2 Modifying a Combined Treatment Regimen
    • 5.1.6.3 Sequencing Regimens in a Combination Treatment Regimen
  • 5.1.7 Maintaining Patterns
  • 5.1.8 Maintaining Treatment Patterns
    • 5.1.8.1 Assigning Treatment Pattern Regimens
    • 5.1.8.2 Displaying Drugs Assigned to Treatment Patterns
    • 5.1.8.3 Copying Treatment Patterns
  • 5.1.9 Maintaining Treatment Pattern Codes
• 5.2 Defining a Study Schedule
  • 5.2.1 Maintaining Intervals
  • 5.2.2 Maintaining Phases
  • 5.2.3 Maintaining Periods
  • 5.2.4 Maintaining Sub-periods
    • 5.2.4.1 Resequencing Phases, Periods and Sub-periods
  • 5.2.5 Assigning Planned Processes and Procedures
    • 5.2.5.1 Maintaining Processes
    • 5.2.5.2 Maintaining Clinical Procedures
• 5.3 Creating Clinical Planned Events
  • 5.3.1 Using CPE Offsets
    • 5.3.1.1 Examples of Offsets

6 Stratification and Randomization

• 6.1 Stratification
  • 6.1.1 Maintaining Factors
    • 6.1.1.1 Glossary of Terms for Factors
  • 6.1.2 Maintaining Single Strata
    • 6.1.2.1 Selecting a Factor
    • 6.1.2.2 Selecting a Stratum
  • 6.1.3 Maintaining Combination Strata and Combined Combination Strata
    • 6.1.3.1 Assigning Strata to Combination or Combined Combination Strata
    • 6.1.3.2 Displaying Strata Assigned to Combination or Combined Combination Strata
  • 6.1.4 Maintaining a Study Stratification Factor
    • 6.1.4.1 Selecting a Clinical Study Version
    • 6.1.4.2 Maintaining Strata
• 6.2 Randomization
  • 6.2.1 Some Concepts
  • 6.2.2 Access
    • 6.2.2.1 Interim Analysis
    • 6.2.2.2 Randomization Privileges
    • 6.2.2.3 Maintaining Blinding in a Study
  • 6.2.3 Choosing a Randomization Type
    • 6.2.3.1 Version-level Randomization
    • 6.2.3.2 Strata-Level Randomization
    • 6.2.3.3 Version Block-Level Randomization
    • 6.2.3.4 Strata Block-Level Randomization
  • 6.2.4 Deleting, Locking/Unlocking, and Verifying Randomizations
  • 6.2.5 Batch Loading a Randomization
    • 6.2.5.1 Downloading a Randomization
      • 6.2.5.1.1 Editing the Randomization Download
      • 6.2.5.1.2 File Format
    • 6.2.5.2 Validating and Loading a Randomization
    • 6.2.5.3 Handling a Legacy Randomization
      • 6.2.5.3.1 Entering Conversion Parameters
      • 6.2.5.3.2 Converted File Format
      • 6.2.5.3.3 Validating a Loaded Randomization
• 6.3 Randomization Maintenance
  • 6.3.1 Replicating a Randomization
  • 6.3.2 Mirroring Randomization
  • 6.3.3 Maintaining Randomization Statuses
  • 6.3.4 Creating or Revoking an Access View
    • 6.3.4.1 Creating an Access View
    • 6.3.4.2 Revoking an Access View
  • 6.3.5 Cohort Views
    • 6.3.5.1 Creating a Cohort View
    • 6.3.5.2 Revoking Cohort View Grants
  • 6.3.6 Managing Patient Treatment Assignments
    • 6.3.6.1 Disclosing a Patient Position's Treatment Pattern
    • 6.3.6.2 Changing the Latest Treatment Assignment to a Different Treatment Pattern
    • 6.3.6.3 Replacing a Patient Position with Another Patient at the Same Site
    • 6.3.6.4 Replacing a Patient Position with Another Patient in the Same Study
    • 6.3.6.5 Linking a Patient Position to an Existing Treatment Assignment
    • 6.3.6.6 Creating a New Treatment Assignment
    • 6.3.6.7 Removing a Treatment Assignment
  • 6.3.7 Linking Patient Treatment Assignments
  • 6.3.8 Disclosing Patient Treatment Assignments

Part II Defining Data Collection Objects

7 Questions and Question Groups

• 7.1 Creating and Maintaining Questions
  • 7.1.1 Creating a New Question
  • 7.1.2 Assigning Question Categories
  • 7.1.3 Extended Text Questions
    • 7.1.3.1 Extended Text Question Usage Restrictions
    • 7.1.3.2 Extended Text Question Definition Restrictions
    • 7.1.3.3 Attachment Prefix
    • 7.1.3.4 Database Storage
      • 7.1.3.4.1 RESPONSES
      • 7.1.3.4.2 RESPONSE_LOBS
  • 7.1.4 Assigning DVGs to a Question
  • 7.1.5 Defining Details for Complex and Question Set Questions
  • 7.1.6 Defining Extended Attributes
  • 7.1.7 Deleting a Provisional Question
• 7.2 Creating and Maintaining Question Groups
  • 7.2.1 Creating a New Question Group
  • 7.2.2 Assigning Questions to a Question Group
  • 7.2.3 Defining Indicator Branching
  • 7.2.4 Creating a Question Group by Copying
  • 7.2.5 Deleting Provisional Question Groups
  • 7.2.6 Managing Question Groups
    • 7.2.6.1 Setting Question Group Status
    • 7.2.6.2 Creating Lists of Values of Question Group Types
• 7.3 Creating and Using DVGs
  • 7.3.1 Alpha DVGs
    • 7.3.1.1 Notes on Using Alpha DVGs
  • 7.3.2 Thesaurus DVGs
    • 7.3.2.1 Creating a Thesaurus DVG
    • 7.3.2.2 Using Thesaurus DVGs with TMS
  • 7.3.3 Creating a DVG
  • 7.3.4 Adding Values to a DVG
  • 7.3.5 Creating a DVG Subset
    • 7.3.5.1 DVG Subset Example
    • 7.3.5.2 Alpha DVG Subset Examples
  • 7.3.6 Maintaining a DVG
    • 7.3.6.1 Modifying a DVG
    • 7.3.6.2 Changing the Status of a DVG
    • 7.3.6.3 Deleting a DVG
  • 7.3.7 Adding DVGs to Active Questions, Question Groups, and DCMs
    • 7.3.7.1 Question Group Questions
    • 7.3.7.2 DCM Question Group Questions
  • 7.3.8 Applying New DVGs to Existing Data
  • 7.3.9 Migrating DVG Changes into Layouts

8 Global Library Activities

• 8.1 Storing Objects in the Global Library
  • 8.1.1 Maintaining Global Library DCMs
  • 8.1.2 Maintaining Global Library DCIs
  • 8.1.3 Maintaining Global Library Procedures
  • 8.1.4 Maintaining Global Library View Definitions
• 8.2 Maintaining Domains
  • 8.2.1 Limiting Access to Definitions Through Domains
  • 8.2.2 Domains of Parent and Child Definitions
  • 8.2.3 Modifying the Domains of Library Definitions
  • 8.2.4 Creating Domains
    • 8.2.4.1 Domains and Prioritization
    • 8.2.4.2 Domains and Object status
  • 8.2.5 Maintaining Domains
    • 8.2.5.1 Creating Default Domain Lists
    • 8.2.5.2 Overriding Default Domain Lists
    • 8.2.5.3 Maintaining User-Level Domain Lists
    • 8.2.5.4 Maintaining Study-Level Domain Lists
  • 8.2.6 Using Domains within the Global Library
    • 8.2.6.1 Querying a Library Object
    • 8.2.6.2 Creating a Library Object
    • 8.2.6.3 Modifying the Domain of a Library Object
    • 8.2.6.4 Copying an Object in the Global Library
    • 8.2.6.5 Adding and Locating Objects
  • 8.2.7 Domain Selection for Data Objects in Studies
    • 8.2.7.1 Domain Rules When Creating or Copying Objects
    • 8.2.7.2 Adding and Locating Objects
  • 8.2.8 Examples of Domain Use
    • 8.2.8.1 Support Conversion and Current Standards
    • 8.2.8.2 Support Project-Specific Standards Exceptions and Development
    • 8.2.8.3 Remove Obsolete Objects to Allow Reuse of Names
    • 8.2.8.4 Create a Special Domain for Testing
• 8.3 Maintaining Standards Affiliations
  • 8.3.1 Using Affiliations
    • 8.3.1.1 Locating Library Objects
    • 8.3.1.2 Mapping Library Objects to Affiliation Types
  • 8.3.2 Maintaining Affiliations
• 8.4 Maintaining Global Library Copy Groups
  • 8.4.1 Copy Group Restrictions
    • 8.4.1.1 Validation Rules
    • 8.4.1.2 DCMs
    • 8.4.1.3 DCIs
    • 8.4.1.4 Procedures
    • 8.4.1.5 View Definitions
    • 8.4.1.6 Copy Rules
    • 8.4.1.7 DCM Copy Rules
    • 8.4.1.8 DCI Copy Rules
    • 8.4.1.9 Procedures Copy Rules
    • 8.4.1.10 View Definitions Copy Rules
  • 8.4.2 Creating a Global Library Copy Group
  • 8.4.3 Performing Copy Group Operations as Batch Jobs
    • 8.4.3.1 Copying from the Global Library to a Study
    • 8.4.3.2 Copying from Study to Study
    • 8.4.3.3 Copying from Your Current Study to the Global Library
  • 8.4.4 Performing Ad Hoc Copies

9 DCMs and DCIs

• 9.1 Defining DCMs
  • 9.1.1 Creating a New DCM
  • 9.1.2 Copying a DCM
  • 9.1.3 Adding Question Groups to a DCM
  • 9.1.4 Configuring Question Groups in a DCM
  • 9.1.5 Adding or Modifying DCM Question
  • 9.1.6 Configuring DCM Subsets
  • 9.1.7 Configuring Qualifying Questions
  • 9.1.8 Using Repeating Question Groups
    • 9.1.8.1 Using Default Repeat Values
  • 9.1.9 Defining Conditional Branching
    • 9.1.9.1 Conditional Branching and Character-Based Layouts
    • 9.1.9.2 Conditional Branching and Graphic Layouts
      • 9.1.9.2.1 Tracking Conditional Block Status at the DCM Level
      • 9.1.9.2.2 How Updating Conditional Branching Definitions Affects DCM/DCI Graphic Layout Flags
  • 9.1.10 Using Normalized Lab Data
  • 9.1.11 Defining Date Formats
  • 9.1.12 Scheduling DCMs
    • 9.1.12.1 Associating DCMs to CPEs
    • 9.1.12.2 Schedule DCMs Form
    • 9.1.12.3 Copying the CPE Schedule
    • 9.1.12.4 Copying the DCM Schedule
    • 9.1.12.5 Resequencing DCMs
• 9.2 Creating Character-Based Layouts
  • 9.2.1 Creating Default DCM Layouts
  • 9.2.2 Creating Additional Layouts
  • 9.2.3 Editing DCM Layouts with the DCM Layout Editor
    • 9.2.3.1 Parts of the DCM Layout Editor
    • 9.2.3.2 Positioning Objects
    • 9.2.3.3 Selecting Objects
      • 9.2.3.3.1 Selecting Individual Objects
      • 9.2.3.3.2 Selecting Contiguous Objects
      • 9.2.3.3.3 Selecting Non-contiguous Objects
    • 9.2.3.4 Editing or Adding Text
    • 9.2.3.5 Adding Boxes
    • 9.2.3.6 Moving Objects
      • 9.2.3.6.1 Moving an Object with the Mouse
      • 9.2.3.6.2 Moving Objects with the Keyboard Arrows
    • 9.2.3.7 Arranging Objects
      • 9.2.3.7.1 Aligning Selected Objects
      • 9.2.3.7.2 Setting Distance Between Repeating Questions
    • 9.2.3.8 Deleting Objects
    • 9.2.3.9 Resizing Objects
      • 9.2.3.9.1 Resizing Individual Rectangles or Text Objects
      • 9.2.3.9.2 Resizing Individual Response Fields
      • 9.2.3.9.3 Resizing Widths of Multiple Selections
    • 9.2.3.10 Controlling Spacing and Sizing of Objects
    • 9.2.3.11 Changing Page Numbers of Objects
  • 9.2.4 Sequencing Data Entry
    • 9.2.4.1 Ordering by Row and Column
    • 9.2.4.2 Ordering by Clicking
    • 9.2.4.3 Ordering by Entering Sequence Numbers
      • 9.2.4.3.1 Reordering Manually
      • 9.2.4.3.2 Reordering with the Plus and Minus Buttons
    • 9.2.4.4 Validating a Layout
    • 9.2.4.5 Saving a Layout
    • 9.2.4.6 Closing the Editor
    • 9.2.4.7 Laid Out Versus Not Laid Out Objects
    • 9.2.4.8 Using Undo or Revert
  • 9.2.5 Using Data Entry Forms in Test and Production Modes
    • 9.2.5.1 Character-Based Layouts in Test and Production Modes
    • 9.2.5.2 Graphic Layouts in Test and Production Modes
• 9.3 Defining DCIs
  • 9.3.1 Creating a DCI
  • 9.3.2 Adding DCMs to DCIs
  • 9.3.3 Defining DCM Pages
  • 9.3.4 Copying a DCI
  • 9.3.5 Marking a DCI as Critical for Source Data Verification
  • 9.3.6 Deleting a DCI
  • 9.3.7 Defining DCI Access at the Study Level

10 Defining DCI Books

• 10.1 Traditional and Enhanced DCI Books
  • 10.1.1 DCI Books
  • 10.1.2 Enhanced DCI Books
    • 10.1.2.1 Support for Flexible Studies
    • 10.1.2.2 Additional Features
• 10.2 Defining an Enhanced DCI Book
  • 10.2.1 Defining Book Properties
  • 10.2.2 Navigator: Building an Enhanced DCI Book
  • 10.2.3 DCI Book Pages: Assigning DCIs to CPEs
    • 10.2.3.1 DCI Book Page Information
    • 10.2.3.2 Rule Trigger Information
  • 10.2.4 Copying Pages for a CPE
  • 10.2.5 Deleting Pages from a CPE
  • 10.2.6 Numbering and Renumbering Pages
    • 10.2.6.1 How Oracle Clinical Page Numbering Works
      • 10.2.6.1.1 Page Number Seeds
    • 10.2.6.2 Renumbering Start Pages
    • 10.2.6.3 Sample Numbering Schemes
      • 10.2.6.3.1 Sequential Integers
      • 10.2.6.3.2 Interval and CPE Prefixes
  • 10.2.7 Defining Interval Rules
    • 10.2.7.1 Defining an Interval Rule Trigger
    • 10.2.7.2 Defining an Interval Rule Target
  • 10.2.8 Defining DCI Rules
    • 10.2.8.1 Defining a DCI Rule Trigger
    • 10.2.8.2 Defining a DCI Rule Target
  • 10.2.9 Validating an Enhanced DCI Book
    • 10.2.9.1 Validation Checks
      • 10.2.9.1.1 Error Conditions for Interval Rules
      • 10.2.9.1.2 Error Conditions for DCI Rules
      • 10.2.9.1.3 Warning Conditions
    • 10.2.9.2 Viewing Validation Warnings and Errors
  • 10.2.10 Defining DCI Book Constraints
• 10.3 Calculating DCI and Interval Expectedness for Patients
  • 10.3.1 Automatic Expectedness Calculation for Patients
    • 10.3.1.1 Automatic Incremental Expectedness Calculation
    • 10.3.1.2 Automatic Full Expectedness Calculation
  • 10.3.2 When and How to Run Expectedness Calculation Manually
    • 10.3.2.1 When to Run Expectedness Calculation Manually
    • 10.3.2.2 How to Run Expectedness Calculation Manually
• 10.4 Data Entry and Expectedness
  • 10.4.1 Data Entry in Remote Data Capture Onsite
  • 10.4.2 Data Entry in Oracle Clinical
• 10.5 Assigning Patients to a DCI Book
• 10.6 Defining a Traditional DCI Book
  • 10.6.1 Creating a DCI Book
  • 10.6.2 Defining DCI Book Constraints
• 10.7 Using CRF Page Tracking
  • 10.7.1 Enabling CRF Page Tracking for a Study
  • 10.7.2 Defining DCIs to Track CRF Pages
  • 10.7.3 Defining DCMs to Track CRF Pages
    • 10.7.3.1 Defining DCM Pages
  • 10.7.4 Defining DCI Books to Track CRF Pages
    • 10.7.4.1 Creating the DCI Book
    • 10.7.4.2 Defining DCI Book Pages
    • 10.7.4.3 Describing Each DCI Page

11 Annotating CRFs

• 11.1 Discussion
  • 11.1.1 Definition
  • 11.1.2 Requirements
  • 11.1.3 Annotation Placement Styles
• 11.2 Procedures
  • 11.2.1 Annotating a DCI Form
    • 11.2.1.1 Procedure
    • 11.2.1.2 Notes
  • 11.2.2 Working with an Annotated CRF in Adobe Acrobat
    • 11.2.2.1 Displaying Acrobat Toolbars
    • 11.2.2.2 Saving an Annotated CRF
    • 11.2.2.3 Opening a Saved Annotated Form
      • 11.2.2.3.1 Notes
    • 11.2.2.4 Methods of Organizing and Viewing Annotations
• 11.3 Using the CRF Annotation Tool Window
  • 11.3.1 Access
  • 11.3.2 Components
  • 11.3.3 DCM Attributes Section
    • 11.3.3.1 Components of the Field Annotations Tab
    • 11.3.3.2 Components of the DCM Block Annotations Tab
    • 11.3.3.3 Components of the Display Characteristics Section
      • 11.3.3.3.1 Display Meta-Data Labels Setting
      • 11.3.3.3.2 Show DCI Name at top of every page Setting
      • 11.3.3.3.3 Annotation Key Field
      • 11.3.3.3.4 Annotation Placement Setting
      • 11.3.3.3.5 Text Setting
      • 11.3.3.3.6 Background Setting

12 Creating Graphic Layouts

• 12.1 Creating a DCI Form
• 12.2 DCI Form Layout Areas
  • 12.2.1 Creating DCI Form Page Definitions
    • 12.2.1.1 Defining Page Definitions
    • 12.2.1.2 About Points
    • 12.2.1.3 About the Starter Page Definitions
    • 12.2.1.4 Sizing Margins
      • 12.2.1.4.1 Sizing Left and Right Margins
      • 12.2.1.4.2 Sizing Top and Bottom Margins
    • 12.2.1.5 Setting Binding Offsets
      • 12.2.1.5.1 Setting Portrait Offsets
      • 12.2.1.5.2 Setting Landscape Offsets
• 12.3 Enabling DCI Forms
• 12.4 Configuring Study-Level DCI Form Settings
  • 12.4.1 Configuring Local Studies
    • 12.4.1.1 DCI Form Runtime
    • 12.4.1.2 General
    • 12.4.1.3 Graphic Layout Editor/Updater
    • 12.4.1.4 Graphic Layout Generator - General
    • 12.4.1.5 Graphic Layout Generator - DCMs
    • 12.4.1.6 DCI Form Generation Defaults
    • 12.4.1.7 Default Settings for Showing DCM Header Fields
    • 12.4.1.8 Default DCM Header Field Prompts
    • 12.4.1.9 Version Migration
    • 12.4.1.10 Patient Data Report
    • 12.4.1.11 Validation
    • 12.4.1.12 Options in Group Verify dialog
    • 12.4.1.13 Options in Group Approve dialog
    • 12.4.1.14 Source Data Verification Plan Defaults
• 12.5 Configuring DVGs and DCI Modules
  • 12.5.1 Configuring DVGs
  • 12.5.2 Configuring DCI Modules' Graphic Layout Settings
• 12.6 Maintaining DCM Graphic Layouts
  • 12.6.1 Generating Default DCM Graphic Layouts
    • 12.6.1.1 Generating Default DCM Graphic Layouts
      • 12.6.1.1.1 Generate Default From Scratch
      • 12.6.1.1.2 Generate Default from Character Layout
      • 12.6.1.1.3 Update from DVG Definition
      • 12.6.1.1.4 Edit
      • 12.6.1.1.5 Browse Layout
  • 12.6.2 DCM Graphic Layout Statuses
• 12.7 Maintaining DCI Graphic Layouts
  • 12.7.1 Viewing DCI Graphic Layouts' Status
    • 12.7.1.1 Viewing Status Values on the Graphic Tab
  • 12.7.2 Generating Provisional DCI Layouts
  • 12.7.3 Generating DCI Forms
  • 12.7.4 Maintaining Form Layout Versions
    • 12.7.4.1 Form Layout Version Rules
    • 12.7.4.2 About the DCI Form Versions Window
    • 12.7.4.3 Changing DCI Form Version Status
    • 12.7.4.4 Changing a PDR's Page Definition
  • 12.7.5 Migrating Data to New Oracle Clinical DCI Form Versions
    • 12.7.5.1 Assigning Patients for Migration
    • 12.7.5.2 Form Migration Examples
    • 12.7.5.3 Maintaining Approvals and Verifications During Form Version Migration
      • 12.7.5.3.1 Setting Up the Reference Codelists
      • 12.7.5.3.2 Setting Up Codelist APPROVE VERIFY RETAIN CODE
      • 12.7.5.3.3 Setting Up Codelist APPROVE VERIFY REVERSE CODE
    • 12.7.5.4 Configuring Default Settings
    • 12.7.5.5 Running Form Version Migration
• 12.8 Maintaining Form Layout Templates
  • 12.8.1 About the Starter Form Layout Templates
  • 12.8.2 Copying a Form Layout Template
  • 12.8.3 Validating Form Layout Templates
• 12.9 Editing Layouts
  • 12.9.1 Introducing the Editor
    • 12.9.1.1 Choosing Unit of Measure
    • 12.9.1.2 Setting Grid Options
  • 12.9.2 Working with Layout Objects
    • 12.9.2.1 About Input Objects
    • 12.9.2.2 About Static Objects
    • 12.9.2.3 Inserting Flex Fields
    • 12.9.2.4 Selecting Objects
      • 12.9.2.4.1 Selecting Individual Objects
      • 12.9.2.4.2 Selecting Contiguous Objects
      • 12.9.2.4.3 Selecting Non-contiguous Objects
      • 12.9.2.4.4 Selecting all Objects
    • 12.9.2.5 Spell Checking
      • 12.9.2.5.1 About the Spell Check Current Option
      • 12.9.2.5.2 About the Find Next Misspelling Operation
    • 12.9.2.6 Positioning Objects
      • 12.9.2.6.1 Moving an Object with the Mouse
      • 12.9.2.6.2 Moving Objects with the Keyboard Arrows
      • 12.9.2.6.3 Positioning Objects from the Properties Dialog Box
      • 12.9.2.6.4 Aligning Selected Objects
    • 12.9.2.7 Grouping Selected Objects
    • 12.9.2.8 Freezing Selected Objects
    • 12.9.2.9 Resizing Objects
      • 12.9.2.9.1 Resizing Individual Rectangles
      • 12.9.2.9.2 Enabling Multiline Text Responses
      • 12.9.2.9.3 Resizing Widths of Multiple Objects
      • 12.9.2.9.4 Specifying Size in the Properties Dialog Box
    • 12.9.2.10 Viewing and Modifying Object Properties
  • 12.9.3 Formatting Masks
    • 12.9.3.1 Changing Mask Formats
    • 12.9.3.2 Resizing Masks
    • 12.9.3.3 Formatting Comb and Box Set Masks
  • 12.9.4 Formatting Label and Prompt Text
  • 12.9.5 About Undo, Redo, and Revert
  • 12.9.6 Setting Cursor Visitation Order
    • 12.9.6.1 Ordering by Row and Column
    • 12.9.6.2 Ordering by Clicking
    • 12.9.6.3 Ordering by Entering Sequence Numbers
      • 12.9.6.3.1 Reordering Manually
      • 12.9.6.3.2 Reordering with the Plus and Minus Buttons
  • 12.9.7 Validating Layouts
  • 12.9.8 Editing DCM Graphic Layouts
    • 12.9.8.1 Editing Blocks
      • 12.9.8.1.1 Inserting Blocks
      • 12.9.8.1.2 Dividing Blocks
      • 12.9.8.1.3 Deleting Blocks
      • 12.9.8.1.4 Resizing Blocks
    • 12.9.8.2 Editing Repeating Question Groups
      • 12.9.8.2.1 Setting Line Height for Repeating Questions
      • 12.9.8.2.2 Ordering Repeating Questions
    • 12.9.8.3 Handling Changes to DCM Definitions
    • 12.9.8.4 Previewing DCM Graphic Layouts
  • 12.9.9 Editing DCI Graphic Layouts
    • 12.9.9.1 Copying DCI Layouts
    • 12.9.9.2 Maintaining Pages
    • 12.9.9.3 Adding Pages
    • 12.9.9.4 Deleting Pages
    • 12.9.9.5 Incorporating Changes to DCM Graphic Layouts
    • 12.9.9.6 Sequencing DCM Header Visitation Order
    • 12.9.9.7 Validating DCI Layouts
  • 12.9.10 Editing Form Layout Templates
    • 12.9.10.1 About the Template Editor's Workspaces
      • 12.9.10.1.1 About the Header Workspace
      • 12.9.10.1.2 About the Footer Workspace
    • 12.9.10.2 Sizing Form Layout Templates
    • 12.9.10.3 Previewing Form Layout Templates
    • 12.9.10.4 Sequencing Visitation Order in Form Layout Templates
• 12.10 Creating and Maintaining Conditional Blocks
  • 12.10.1 Creating Conditional Blocks
    • 12.10.1.1 Conditional Block Display
    • 12.10.1.2 Nested Conditional Blocks
  • 12.10.2 Invalid Conditional Block Conditions
  • 12.10.3 Maintaining Conditional Blocks
  • 12.10.4 About Conditional Blocks in DCI Form Versions
• 12.11 Troubleshooting Graphic Layout Problems
  • 12.11.1 FRM 41213 Followed by a 771000 Error Message
  • 12.11.2 FRM-41214 Followed by a 777100 Error Message
  • 12.11.3 Nothing Happens When You Try to Generate a Provisional DCI Form

13 Copy Groups

• 13.1 Creating Copy Groups
• 13.2 Grouping Objects
• 13.3 Adding DCMs
• 13.4 Adding DCIs
• 13.5 Adding Procedures
• 13.6 Adding View Definitions

14 Data Extract

• 14.1 The View Builder's Structure
  • 14.1.1 Global Library
    • 14.1.1.1 About View Templates
    • 14.1.1.2 About Key Templates
    • 14.1.1.3 About Extract Macros
    • 14.1.1.4 About Complex and Simple Questions
      • 14.1.1.4.1 Maintaining Question Details
    • 14.1.1.5 About Extended Question Attributes
      • 14.1.1.5.1 Maintaining Extended Attributes
      • 14.1.1.5.2 Discrete Value Group Translation for Applicable Variables
      • 14.1.1.5.3 Specifying Explicit Access to Other Response Information
    • 14.1.1.6 Example of Associating Extract Macros to Questions
      • 14.1.1.6.1 Step 1
      • 14.1.1.6.2 Step 2
      • 14.1.1.6.3 Step 3
      • 14.1.1.6.4 Step 4
  • 14.1.2 Definition
• 14.2 A Sample Workflow
• 14.3 Customizing Data Extract
  • 14.3.1 Copying
  • 14.3.2 Create Extract Macros
    • 14.3.2.1 Simplified Extract Macro Workflow
    • 14.3.2.2 Attributes of a SQL Macro
    • 14.3.2.3 Example
    • 14.3.2.4 Macro Data Type
    • 14.3.2.5 Some SQL*Plus Functions
    • 14.3.2.6 Some Examples of SQL and SAS Macros
    • 14.3.2.7 Some Hints for SAS Users
    • 14.3.2.8 Defining Extract Macros Using the Maintain Extract Macros Window
    • 14.3.2.9 Changing a Macro Definition
    • 14.3.2.10 Listing Available Functions in the Database
  • 14.3.3 Creating Key Templates
    • 14.3.3.1 Maintain/Query Key Templates
    • 14.3.3.2 Customize/Query Key Template Columns
    • 14.3.3.3 Order Specification for Data Viewing
    • 14.3.3.4 Aggregation
  • 14.3.4 Create Questions and View Templates
    • 14.3.4.1 Associating Questions with Views
  • 14.3.5 Maintaining View Definitions
    • 14.3.5.1 Linking a View Definition to a DCM
    • 14.3.5.2 Viewing the Data for a View Definition
    • 14.3.5.3 View Model
    • 14.3.5.4 Creating View Templates
    • 14.3.5.5 Mapping DCM Questions to View Template Questions
    • 14.3.5.6 Having Clauses
    • 14.3.5.7 Copying a View Definition
  • 14.3.6 Defining Study Sets
  • 14.3.7 Creating Union Views
    • 14.3.7.1 Creating a Cross-study Union
    • 14.3.7.2 Troubleshooting Cross-study Union Views
    • 14.3.7.3 Creating In-Study Union Views
    • 14.3.7.4 Example of Union Views
  • 14.3.8 Creating Where Clauses
    • 14.3.8.1 Copying Where Clauses
  • 14.3.9 Adding DISTINCT terms
  • 14.3.10 About Joining Fast Extract Views
  • 14.3.11 General Example

15 Lab Ranges

• 15.1 Establishing Units of Measure
  • 15.1.1 Defining Lab Units
  • 15.1.2 Defining lab test Question Units
  • 15.1.3 Defining Unit Conversions
    • 15.1.3.1 Testing a Lab Conversion Calculation
  • 15.1.4 Defining Preferred Conversion Groups
• 15.2 Defining Standard Lab Ranges
  • 15.2.1 Defining Textbook Ranges
  • 15.2.2 Defining Preferred Copy Groups
  • 15.2.3 Defining Lab Panels
  • 15.2.4 Defining Labs
  • 15.2.5 Defining Specific Lab Ranges
    • 15.2.5.1 Age
    • 15.2.5.2 Effective Date
    • 15.2.5.3 Lab Range Records without Effective Start or Effective End Dates
    • 15.2.5.4 Defining Lab Ranges Using the Maintain Lab Ranges Window
  • 15.2.6 Defining Lab Subsets
    • 15.2.6.1 Defining the Subset Name
    • 15.2.6.2 Defining the Subset Range Values
  • 15.2.7 Using Textbook Ranges
  • 15.2.8 Copying Lab Ranges
• 15.3 Lab Assignment Criteria
  • 15.3.1 Example of Lab Assignment Criteria Evolution
  • 15.3.2 Applying Lab Assignment Criteria
    • 15.3.2.1 Granting Privileged Update to a User
  • 15.3.3 Resolving Problems
    • 15.3.3.1 Missing Lab References in the RDCMs
    • 15.3.3.2 Missing Data in Patient Positions
• 15.4 Batch Loading Lab Ranges
  • 15.4.1 Loading Data
    • 15.4.1.1 File Format
    • 15.4.1.2 Example
  • 15.4.2 Validating Data
  • 15.4.3 Transferring Data
    • 15.4.3.1 Example
  • 15.4.4 Executing the Process
  • 15.4.5 Running the Lab Procedures Re-execution Pre-Process Batch Job

16 Validation and Derivation Procedures

• 16.1 About Validation Procedures
  • 16.1.1 Examples of Validation Procedures
    • 16.1.1.1 Simple Validation Procedure
    • 16.1.1.2 Validation Procedure with an Arithmetic Function
    • 16.1.1.3 More Complex Validation Procedure
• 16.2 About Derivation Procedures
  • 16.2.1 Restrictions on Derivation Procedures
  • 16.2.2 Examples of Derivation Procedures
• 16.3 Overview of Defining a Procedure
• 16.4 How Procedures Work Internally
  • 16.4.1 Cursors
    • 16.4.1.1 Patient Information Cursors
    • 16.4.1.2 Procedure Question Group Cursors
  • 16.4.2 Structure of Procedure PL/SQL Programs
    • 16.4.2.1 Example: Procedure with More Than One Procedure Question Group
    • 16.4.2.2 Example: Procedure Containing One Procedure Question Group
    • 16.4.2.3 Example: Procedure with Multiple DCMs
    • 16.4.2.4 Sort Order
    • 16.4.2.5 Sample Procedure Code, with Custom Code Locations
  • 16.4.3 Viewing Generated PL/SQL Code
• 16.5 Special Processing
  • 16.5.1 Correlation
    • 16.5.1.1 Correlation on Event
    • 16.5.1.2 Correlation by Qualifying Value
    • 16.5.1.3 Correlation by Question Value
    • 16.5.1.4 Restrictions
    • 16.5.1.5 Setting Up Correlation
  • 16.5.2 Aggregate Functions
    • 16.5.2.1 Variable Names
    • 16.5.2.2 Restrictions
    • 16.5.2.3 Setting up Aggregate Functions
  • 16.5.3 Aggregate Lag Functions
    • 16.5.3.1 Variable Names
    • 16.5.3.2 Restrictions on Aggregate Lag Functions
    • 16.5.3.3 Using Aggregate Lag Functions
  • 16.5.4 Lag Checks
    • 16.5.4.1 Variable Names
    • 16.5.4.2 Setting Up Lag Checks
    • 16.5.4.3 Lag Check Examples
      • 16.5.4.3.1 Populating Lag Variables
      • 16.5.4.3.2 Lag Values for Data from a Repeating Question Group
      • 16.5.4.3.3 Including Null in Lag
      • 16.5.4.3.4 Not Including Null in Lag
      • 16.5.4.3.5 Qualifying Expressions and Lags
  • 16.5.5 Where Clause Extension
  • 16.5.6 Qualifying Expression
  • 16.5.7 Custom Code
• 16.6 Procedure Variables
  • 16.6.1 Question Variables
  • 16.6.2 Aggregate and Lab Attribute Variables
    • 16.6.2.1 Aggregate Variables
    • 16.6.2.2 Lab Attribute Variables
  • 16.6.3 System Variables
    • 16.6.3.1 Standard Variables
    • 16.6.3.2 Question Group Variables
      • 16.6.3.2.1 DCM Key Variables
      • 16.6.3.2.2 Question Group Standard Variables
      • 16.6.3.2.3 Response-Related Variables
      • 16.6.3.2.4 Other Question Group Variables
    • 16.6.3.3 DVG Variables
  • 16.6.4 User Variables
• 16.7 Using Lab Ranges
• 16.8 Defining Validation and Derivation Procedures
  • 16.8.1 Where to Start
    • 16.8.1.1 Creating an Entirely New Procedure
    • 16.8.1.2 Creating a New Version of a Procedure
    • 16.8.1.3 Modifying an Existing Procedure
  • 16.8.2 Procedure Definition Sequence
  • 16.8.3 Naming and Describing a Procedure
    • 16.8.3.1 Access Privileges
    • 16.8.3.2 Defining a Procedure
      • 16.8.3.2.1 Name
      • 16.8.3.2.2 Domain
      • 16.8.3.2.3 Version
      • 16.8.3.2.4 Status
      • 16.8.3.2.5 Sort Order
      • 16.8.3.2.6 Execution Context
      • 16.8.3.2.7 Category
      • 16.8.3.2.8 Ver 3.1 Style?
      • 16.8.3.2.9 Lab Range Dependent?
  • 16.8.4 Defining Procedure Question Groups
    • 16.8.4.1 Performance Issues
    • 16.8.4.2 About the Question Groups Window
      • 16.8.4.2.1 Alias
      • 16.8.4.2.2 Aggregate?
      • 16.8.4.2.3 Primary Reference
      • 16.8.4.2.4 First in the Event Range
      • 16.8.4.2.5 Last in the Event Range
      • 16.8.4.2.6 Sort Order Event
      • 16.8.4.2.7 Sort Order Extension
      • 16.8.4.2.8 First/Last Event Only
      • 16.8.4.2.9 Single Repeat Only?
      • 16.8.4.2.10 Create Place Holder?
      • 16.8.4.2.11 Correlate With
      • 16.8.4.2.12 Where Clause Extension
      • 16.8.4.2.13 Qualifying Expression
      • 16.8.4.2.14 Custom Code
  • 16.8.5 Defining Procedure Questions
  • 16.8.6 Defining Correlating Questions for Procedure Question Groups
  • 16.8.7 Defining User Variables
    • 16.8.7.1 Variable Name
    • 16.8.7.2 Init Alias
    • 16.8.7.3 Data Type
    • 16.8.7.4 Length
    • 16.8.7.5 Decimal Places
    • 16.8.7.6 Initial Value
    • 16.8.7.7 Report
    • 16.8.7.8 Description
  • 16.8.8 Defining Procedure Details
    • 16.8.8.1 Order Number
    • 16.8.8.2 Continue If Discrepancy
    • 16.8.8.3 Test Not Null Only
    • 16.8.8.4 Detail Types
    • 16.8.8.5 Externally Derived
    • 16.8.8.6 Failure Type
    • 16.8.8.7 Description
    • 16.8.8.8 Expression
    • 16.8.8.9 Message
    • 16.8.8.10 Discrepancy Code
  • 16.8.9 Using System Variables in Pre-v3.1-Style Procedures
  • 16.8.10 Using Variables in V3.1-Style Procedures
    • 16.8.10.1 Variable
    • 16.8.10.2 Perform Detail Only If...
      • 16.8.10.2.1 Not Null
      • 16.8.10.2.2 No Univariate Error(s)
      • 16.8.10.2.3 Unresolved
    • 16.8.10.3 Discrepancy Test
    • 16.8.10.4 Report
    • 16.8.10.5 Report Order
  • 16.8.11 Adding Custom Code
    • 16.8.11.1 Adding Custom Code
• 16.9 Testing and Activating Procedures
  • 16.9.1 Generating and Compiling a Procedure
  • 16.9.2 Editing Generated PL/SQL Code
  • 16.9.3 Testing a Procedure
    • 16.9.3.1 Testing a Procedure from Definition
    • 16.9.3.2 Testing a Procedure from Test a Study
  • 16.9.4 Assigning Procedure Status
  • 16.9.5 Assigning Standards Affiliation
• 16.10 Executing Procedures
  • 16.10.1 Executing a Single Procedure
    • 16.10.1.1 Execute a Single Procedure from the PSUB Window
    • 16.10.1.2 Execute a Single Procedure from the Procedures Window
  • 16.10.2 Executing Batch Validation
    • 16.10.2.1 Facts About Procedure Execution During Batch Validation
    • 16.10.2.2 Batch Validating TMS Derivation Procedures
    • 16.10.2.3 Procedures and Frozen-status Patients
• 16.11 V3.1-Style and Pre-V3.1-Style Procedures
  • 16.11.1 V3.1-Style Procedure Enhancements
  • 16.11.2 Converting to the V3.1 Style
    • 16.11.2.1 Conversion Example
  • 16.11.3 Creating a New Pre-V3.1-Style Procedure
• 16.12 Maintaining Patient Statuses
  • 16.12.1 Populating the Patient Statuses Table
    • 16.12.1.1 Example
      • 16.12.1.1.1 Procedures
      • 16.12.1.1.2 Procedure Question Groups
      • 16.12.1.1.3 Procedure Questions
      • 16.12.1.1.4 Procedure Details
      • 16.12.1.1.5 Variable Settings
      • 16.12.1.1.6 Custom Code
  • 16.12.2 Patient Synchronization
    • 16.12.2.1 Procedure Definition
  • 16.12.3 Example
  • 16.12.4 Pre-Details Custom Code
  • 16.12.5 Alternative Approaches to Error Reporting
    • 16.12.5.1 Single Failure
    • 16.12.5.2 Multiple Failure
  • 16.12.6 Type Coercion and Comparison of Derived Values

17 Test Mode

• 17.1 Overview
  • 17.1.1 A Typical Test Mode Workflow
  • 17.1.2 How Test Data and Production Data Differ
  • 17.1.3 Test Mode Limitations
• 17.2 Launching Test Mode Sessions
• 17.3 Setting Up Test Study Design
  • 17.3.1 About Test Mode Synonyms
• 17.4 Creating and Loading Test Data
  • 17.4.1 Creating Test Data
  • 17.4.2 Batch Loading Test Data
  • 17.4.3 Using Test Mode Batch Data Delete
• 17.5 Testing Definitions
  • 17.5.1 Testing Validation Procedures
  • 17.5.2 Testing Derivation Procedures
  • 17.5.3 Batch Validating Test Data
  • 17.5.4 Testing Layouts in Oracle Clinical
  • 17.5.5 Testing Layouts in Remote Data Capture (RDC) OnSite
  • 17.5.6 Testing in Debug Mode
  • 17.5.7 Checking Validation Results
  • 17.5.8 Testing Mass Changes
  • 17.5.9 Testing Data Extract Views

18 Integrating with a Clinical Trial Management System

• 18.1 Enabling Patient and Subject Activity Integration
  • 18.1.1 Enabling Integration at the Database Level
  • 18.1.2 Overriding Default Integration Values for Individual Studies
• 18.2 Setting Up and Using Activity Completion Integration
  • 18.2.1 Creating Activity Completion Criteria
  • 18.2.2 Adding Activity Completion Criteria Details
  • 18.2.3 Running the Track Activities Batch Job
  • 18.2.4 Completion Criteria Processing
    • 18.2.4.1 Completeness Logic
    • 18.2.4.2 Completion Date Updates

A Flexible Study Design Examples

• A.1 Basic Examples
  • A.1.1 Enabling a DCI within a Clinical Planned Event
  • A.1.2 Enabling DCIs Across Clinical Planned Events
  • A.1.3 Enabling Intervals Based on the Collection of Any Data
  • A.1.4 Enabling Intervals Based on a Data Value
  • A.1.5 Skipping to an Interval
  • A.1.6 Enabling the Next Interval
• A.2 Complex Examples
  • A.2.1 Defining Multiple Paths Through a Trial
  • A.2.2 Enabling DCIs in a Conditional Interval
  • A.2.3 Defining Multiple Conditional Pretreatment Intervals and DCIs

Index