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 Overview of Creating a Study

• Global Library
• Design
  • Easy Study Design
  • Standard Design
    • Planning
    • Clinical Study
    • Clinical Study Versions
    • Planned Study Intervals
    • Clinical Planned Events and Clinical Processes
    • Treatment Patterns
    • Patient Positions
    • Blinding
    • Stratification
    • Randomization
• Definition
  • Definition Components
    • Data Collection Modules
    • Data Collection Instruments
    • DCI Books
    • CRF Page Tracking
    • Procedures
    • Validation Procedures
    • Derivation Procedures
    • Labs
    • Data Extract
  • Data Entry and Report Layout Design
    • Character-Based Layouts
    • Graphic Layouts

Part I Designing Studies

2 Planning and Designing a Study

• Maintaining Programs
• Defining Projects
• Assigning Compounds
• Creating Organization Units
• Maintaining Regions
  • Deleting a Region
  • Updating a Region
  • Maintaining Region Components
    • Maintaining Parent Regions
    • Maintaining Child Regions
• Creating Planned Studies
• Creating a Clinical Study
  • Maintaining Clinical Study Objectives
  • Maintaining Enrollment Criteria
  • Maintaining Study Termination Criteria
  • Creating Clinical Study Comments
  • Assigning Clinical Study Regions
  • Maintaining a Clinical Study's Historical Events
  • Reviewing Planning Details
  • Updating Clinical Study Statuses
  • Deleting a Clinical Study
• Designing Response-Dependent Branching
• Designing a Flexible Study
  • Enabling Flexible Study Functionality
  • Defining Intervals and CPEs for Flexible Studies
  • Using a Single DCI Book
  • Using Rules
    • Rule Triggers
    • Rule Targets
• Using Oracle Clinical-Siebel Clinical Integration
• Copying Clinical Studies
  • Replicating Clinical Studies
  • Creating Study Versions
    • Copy Logic for Clinical Study Versions
• Planning Study and Site Enrollment
• Creating a New Study Plan
• Study Site Plans
• Maintaining Clinical Study States

3 Easy Study Design

• Overview of Easy Study Design
  • Using Easy Study Design
  • Data Structure Compatibility
  • Querying a Study
• Creating a Clinical Study in the Easy Study Design Window
  • Planning Study Intervals
    • Creating Periods
    • Resequencing Periods
    • Creating Sub-periods
    • Resequencing Sub-periods
  • Defining Clinical Planned Events
  • Defining Treatment Patterns
  • Creating Patient Positions
    • Displaying Patient Positions
    • Deleting Patient Positions
• Completing Easy Study Design

4 Sites, Investigators, and Patient Positions

• Maintaining Site Records
  • Creating Site Records
  • Assigning Sites to a Study
• Maintaining Investigator Records
  • Creating Investigator Records
  • Assigning Investigators to Study Sites
• Maintaining Patient Positions
  • Creating Patient Positions
    • Creating Patient Positions with System-Generated Codes
    • Creating Patient Positions with User-Defined Codes
  • Assigning Patient Positions to Sites
    • Assigning Patient Positions from the Study Sites Window
    • Assigning Patient Positions from the Patient Positions Window
    • Assigning Patient Positions by Range
    • Assigning New Blocks of Patient Positions
  • Changing Owning Locations
  • Retrieving Patient Positions
  • Deleting Patient Positions
    • Deleting System-Generated Patient Positions
    • Deleting Alpha Code Patient Positions
  • Enrolling Patients in a Study
    • Adding Patient Position Details
    • Batch Load Patient Enrollment Dates
  • Linking Patient Positions in Different Studies
  • Assigning Patient Positions to DCI Books
    • Assigning Patient Positions by Range
    • Assigning Patient Positions by Site
    • Assigning Patient Positions by Study
• Treatment Assignments
  • Assigning Selected Treatment Assignments to a Site
  • Linking Treatment Assignments
    • Linking Treatment Assignments by Range
    • Linking Treatment Assignment Ranges to a Site
• Blind Breaks
  • Creating, Reviewing, or Canceling Blind Breaks

5 Treatments and Schedules

• Treatments
  • Maintaining Active Substances
  • Maintaining Drugs
  • Maintaining Single Treatment Regimens
  • Creating or Modifying a Single Treatment Regimen
    • Specifying Dosage by Range
    • Maintaining Non-linear Titration Steps for a Treatment Regimen
  • Maintaining Daily Dosage Details for a Treatment Regimen
    • Changing the Drug Assigned to a Treatment Regimen
  • Maintaining Combined Treatment Regimens
    • Creating a New Combined Treatment Regimen
    • Modifying a Combined Treatment Regimen
    • Sequencing Regimens in a Combination Treatment Regimen
  • Maintaining Patterns
  • Maintaining Treatment Patterns
    • Assigning Treatment Pattern Regimens
    • Displaying Drugs Assigned to Treatment Patterns
    • Copying Treatment Patterns
  • Maintaining Treatment Pattern Codes
• Defining a Study Schedule
  • Maintaining Intervals
  • Maintaining Phases
  • Maintaining Periods
  • Maintaining Sub-periods
    • Resequencing Phases, Periods and Sub-periods
  • Assigning Planned Processes and Procedures
    • Maintaining Processes
    • Maintaining Clinical Procedures
• Creating Clinical Planned Events
  • Using CPE Offsets
    • Examples of Offsets

6 Stratification and Randomization

• Stratification
  • Maintaining Factors
    • Glossary of Terms for Factors
  • Maintaining Single Strata
    • Selecting a Factor
    • Selecting a Stratum
  • Maintaining Combination Strata and Combined Combination Strata
    • Assigning Strata to Combination or Combined Combination Strata
    • Displaying Strata Assigned to Combination or Combined Combination Strata
  • Maintaining a Study Stratification Factor
    • Selecting a Clinical Study Version
    • Maintaining Strata
• Randomization
  • Some Concepts
  • Access
    • Interim Analysis
    • Randomization Privileges
    • Maintaining Blinding in a Study
  • Choosing a Randomization Type
    • Version-level Randomization
    • Strata-Level Randomization
    • Version Block-Level Randomization
    • Strata Block-Level Randomization
  • Deleting, Locking/Unlocking, and Verifying Randomizations
  • Batch Loading a Randomization
    • Downloading a Randomization
    • Validating and Loading a Randomization
    • Handling a Legacy Randomization
• Randomization Maintenance
  • Replicating a Randomization
  • Mirroring Randomization
  • Maintaining Randomization Statuses
  • Creating or Revoking an Access View
    • Creating an Access View
    • Revoking an Access View
  • Cohort Views
    • Creating a Cohort View
    • Revoking Cohort View Grants
  • Managing Patient Treatment Assignments
    • Disclosing a Patient Position's Treatment Pattern
    • Changing the Latest Treatment Assignment to a Different Treatment Pattern
    • Replacing a Patient Position with Another Patient at the Same Site
    • Replacing a Patient Position with Another Patient in the Same Study
    • Linking a Patient Position to an Existing Treatment Assignment
    • Creating a New Treatment Assignment
    • Removing a Treatment Assignment
  • Linking Patient Treatment Assignments
  • Disclosing Patient Treatment Assignments

Part II Defining Data Collection Objects

7 Questions and Question Groups

• Creating and Maintaining Questions
  • Creating a New Question
  • Assigning Question Categories
  • Extended Text Questions
    • Extended Text Question Usage Restrictions
    • Extended Text Question Definition Restrictions
    • Attachment Prefix
    • Database Storage
  • Assigning DVGs to a Question
  • Defining Details for Complex and Question Set Questions
  • Defining Extended Attributes
  • Deleting a Provisional Question
• Creating and Maintaining Question Groups
  • Creating a New Question Group
  • Assigning Questions to a Question Group
  • Defining Indicator Branching
  • Creating a Question Group by Copying
  • Deleting Provisional Question Groups
  • Managing Question Groups
    • Setting Question Group Status
    • Creating Lists of Values of Question Group Types
• Creating and Using DVGs
  • Alpha DVGs
    • Notes on Using Alpha DVGs
  • Thesaurus DVGs
    • Creating a Thesaurus DVG
    • Using Thesaurus DVGs with TMS
  • Creating a DVG
  • Adding Values to a DVG
  • Creating a DVG Subset
    • DVG Subset Example
    • Alpha DVG Subset Examples
  • Maintaining a DVG
    • Modifying a DVG
    • Changing the Status of a DVG
    • Deleting a DVG
  • Adding DVGs to Active Questions, Question Groups, and DCMs
    • Question Group Questions
    • DCM Question Group Questions
  • Applying New DVGs to Existing Data
  • Migrating DVG Changes into Layouts

8 Global Library Activities

• Storing Objects in the Global Library
  • Maintaining Global Library DCMs
  • Maintaining Global Library DCIs
  • Maintaining Global Library Procedures
  • Maintaining Global Library View Definitions
• Maintaining Domains
  • Limiting Access to Definitions Through Domains
  • Domains of Parent and Child Definitions
  • Modifying the Domains of Library Definitions
  • Creating Domains
    • Domains and Prioritization
    • Domains and Object status
  • Maintaining Domains
    • Creating Default Domain Lists
    • Overriding Default Domain Lists
    • Maintaining User-Level Domain Lists
    • Maintaining Study-Level Domain Lists
  • Using Domains within the Global Library
    • Querying a Library Object
    • Creating a Library Object
    • Modifying the Domain of a Library Object
    • Copying an Object in the Global Library
    • Adding and Locating Objects
  • Domain Selection for Data Objects in Studies
    • Domain Rules When Creating or Copying Objects
    • Adding and Locating Objects
  • Examples of Domain Use
    • Support Conversion and Current Standards
    • Support Project-Specific Standards Exceptions and Development
    • Remove Obsolete Objects to Allow Reuse of Names
    • Create a Special Domain for Testing
• Maintaining Standards Affiliations
  • Using Affiliations
    • Locating Library Objects
    • Mapping Library Objects to Affiliation Types
  • Maintaining Affiliations
• Maintaining Global Library Copy Groups
  • Copy Group Restrictions
    • Validation Rules
    • DCMs
    • DCIs
    • Procedures
    • View Definitions
    • Copy Rules
    • DCM Copy Rules
    • DCI Copy Rules
    • Procedures Copy Rules
    • View Definitions Copy Rules
  • Creating a Global Library Copy Group
  • Performing Copy Group Operations as Batch Jobs
    • Copying from the Global Library to a Study
    • Copying from Study to Study
    • Copying from Your Current Study to the Global Library
  • Performing Ad Hoc Copies

9 DCMs and DCIs

• Defining DCMs
  • Creating a New DCM
  • Copying a DCM
  • Adding Question Groups to a DCM
  • Configuring Question Groups in a DCM
  • Adding or Modifying DCM Question
  • Configuring DCM Subsets
  • Configuring Qualifying Questions
  • Using Repeating Question Groups
    • Using Default Repeat Values
  • Defining Conditional Branching
    • Conditional Branching and Character-Based Layouts
    • Conditional Branching and Graphic Layouts
  • Using Normalized Lab Data
  • Defining Date Formats
  • Scheduling DCMs
    • Associating DCMs to CPEs
    • Schedule DCMs Form
    • Copying the CPE Schedule
    • Copying the DCM Schedule
    • Resequencing DCMs
• Creating Character-Based Layouts
  • Creating Default DCM Layouts
  • Creating Additional Layouts
  • Editing DCM Layouts with the DCM Layout Editor
    • Parts of the DCM Layout Editor
    • Positioning Objects
    • Selecting Objects
    • Editing or Adding Text
    • Adding Boxes
    • Moving Objects
    • Arranging Objects
    • Deleting Objects
    • Resizing Objects
    • Controlling Spacing and Sizing of Objects
    • Changing Page Numbers of Objects
  • Sequencing Data Entry
    • Ordering by Row and Column
    • Ordering by Clicking
    • Ordering by Entering Sequence Numbers
    • Validating a Layout
    • Saving a Layout
    • Closing the Editor
    • Laid Out Versus Not Laid Out Objects
    • Using Undo or Revert
  • Using Data Entry Forms in Test and Production Modes
    • Character-Based Layouts in Test and Production Modes
    • Graphic Layouts in Test and Production Modes
• Defining DCIs
  • Creating a DCI
  • Adding DCMs to DCIs
  • Defining DCM Pages
  • Copying a DCI
  • Deleting a DCI
  • Defining DCI Access at the Study Level

10 Defining DCI Books

• Traditional and Enhanced DCI Books
  • DCI Books
  • Enhanced DCI Books
    • Support for Flexible Studies
    • Additional Features
• Defining an Enhanced DCI Book
  • Defining Book Properties
  • Navigator: Building an Enhanced DCI Book
  • DCI Book Pages: Assigning DCIs to CPEs
    • DCI Book Page Information
    • Rule Trigger Information
  • Copying Pages for a CPE
  • Deleting Pages from a CPE
  • Numbering and Renumbering Pages
    • How Oracle Clinical Page Numbering Works
    • Renumbering Start Pages
    • Sample Numbering Schemes
  • Defining Interval Rules
    • Defining an Interval Rule Trigger
    • Defining an Interval Rule Target
  • Defining DCI Rules
    • Defining a DCI Rule Trigger
    • Defining a DCI Rule Target
  • Validating an Enhanced DCI Book
    • Validation Checks
    • Viewing Validation Warnings and Errors
  • Defining DCI Book Constraints
• Calculating DCI and Interval Expectedness for Patients
  • Automatic Expectedness Calculation for Patients
    • Automatic Incremental Expectedness Calculation
    • Automatic Full Expectedness Calculation
  • When and How to Run Expectedness Calculation Manually
    • When to Run Expectedness Calculation Manually
    • How to Run Expectedness Calculation Manually
• Data Entry and Expectedness
  • Data Entry in Remote Data Capture Onsite
  • Data Entry in Oracle Clinical and Classic Remote Data Capture
• Assigning Patients to a DCI Book
• Defining a Traditional DCI Book
  • Creating a DCI Book
  • Defining DCI Book Constraints
• Using CRF Page Tracking
  • Enabling CRF Page Tracking for a Study
  • Defining DCIs to Track CRF Pages
  • Defining DCMs to Track CRF Pages
    • Defining DCM Pages
  • Defining DCI Books to Track CRF Pages
    • Creating the DCI Book
    • Defining DCI Book Pages
    • Describing Each DCI Page

11 Creating Graphic Layouts

• Creating a DCI Form
• DCI Form Layout Areas
  • Creating DCI Form Page Definitions
    • Defining Page Definitions
    • About Points
    • About the Starter Page Definitions
    • Sizing Margins
    • Setting Binding Offsets
• Enabling DCI Forms
• Configuring Study-Level DCI Form Settings
  • Configuring Local Studies
    • DCI Form Runtime
    • General
    • Graphic Layout Editor/Updater
    • Graphic Layout Generator - General
    • Graphic Layout Generator - DCMs
    • DCI Form Generation Defaults
    • Default Settings for Showing DCM Header Fields
    • Default DCM Header Field Prompts
    • Version Migration
    • Patient Data Report
    • Validation
• Configuring DVGs and DCI Modules
  • Configuring DVGs
  • Configuring DCI Modules' Graphic Layout Settings
• Maintaining DCM Graphic Layouts
  • Generating Default DCM Graphic Layouts
    • Generating Default DCM Graphic Layouts
  • DCM Graphic Layout Statuses
• Maintaining DCI Graphic Layouts
  • Viewing DCI Graphic Layouts' Status
    • Viewing Status Values on the Graphic Tab
  • Generating Provisional DCI Layouts
  • Generating DCI Forms
  • Maintaining Form Layout Versions
    • Form Layout Version Rules
    • About the DCI Form Versions Window
    • Changing DCI Form Version Status
    • Changing a PDR's Page Definition
  • Migrating Data to New Oracle Clinical DCI Form Versions
    • Assigning Patients for Migration
    • Form Migration Examples
    • Maintaining Approvals and Verifications During Form Version Migration
    • Configuring Default Settings
    • Running Form Version Migration
• Maintaining Form Layout Templates
  • About the Starter Form Layout Templates
  • Copying a Form Layout Template
  • Validating Form Layout Templates
• Editing Layouts
  • Introducing the Editor
    • Choosing Unit of Measure
    • Setting Grid Options
  • Working with Layout Objects
    • About Input Objects
    • About Static Objects
    • Inserting Flex Fields
    • Selecting Objects
    • Spell Checking
    • Positioning Objects
    • Grouping Selected Objects
    • Freezing Selected Objects
    • Resizing Objects
    • Viewing and Modifying Object Properties
  • Formatting Masks
    • Changing Mask Formats
    • Resizing Masks
    • Formatting Comb and Box Set Masks
  • Formatting Label and Prompt Text
  • About Undo, Redo, and Revert
  • Setting Cursor Visitation Order
    • Ordering by Row and Column
    • Ordering by Clicking
    • Ordering by Entering Sequence Numbers
  • Validating Layouts
  • Editing DCM Graphic Layouts
    • Editing Blocks
    • Editing Repeating Question Groups
    • Handling Changes to DCM Definitions
    • Previewing DCM Graphic Layouts
  • Editing DCI Graphic Layouts
    • Copying DCI Layouts
    • Maintaining Pages
    • Adding Pages
    • Deleting Pages
    • Incorporating Changes to DCM Graphic Layouts
    • Sequencing DCM Header Visitation Order
    • Validating DCI Layouts
  • Editing Form Layout Templates
    • About the Template Editor's Workspaces
    • Sizing Form Layout Templates
    • Previewing Form Layout Templates
    • Sequencing Visitation Order in Form Layout Templates
• Creating and Maintaining Conditional Blocks
  • Creating Conditional Blocks
    • Conditional Block Display
    • Nested Conditional Blocks
  • Invalid Conditional Block Conditions
  • Maintaining Conditional Blocks
  • About Conditional Blocks in DCI Form Versions
• Troubleshooting Graphic Layout Problems
  • FRM 41213 Followed by a 771000 Error Message
  • FRM-41214 Followed by a 777100 Error Message
  • Nothing Happens When You Try to Generate a Provisional DCI Form

12 Annotating CRFs

• Discussion
  • Definition
  • Requirements
  • Annotation Placement Styles
• Procedures
  • Annotating a DCI Form
    • Procedure
    • Notes
  • Working with an Annotated CRF in Adobe Acrobat
    • Displaying Acrobat Toolbars
    • Saving an Annotated CRF
    • Opening a Saved Annotated Form
    • Methods of Organizing and Viewing Annotations
• Using the CRF Annotation Tool Window
  • Access
  • Components
  • DCM Attributes Section
    • Components of the Field Annotations Tab
    • Components of the DCM Block Annotations Tab
    • Components of the Display Characteristics Section

13 Copy Groups

• Creating Copy Groups
• Grouping Objects
• Adding DCMs
• Adding DCIs
• Adding Procedures
• Adding View Definitions

14 Data Extract

• The View Builder's Structure
  • Global Library
    • About View Templates
    • About Key Templates
    • About Extract Macros
    • About Complex and Simple Questions
    • About Extended Question Attributes
    • Example of Associating Extract Macros to Questions
  • Definition
• A Sample Workflow
• Customizing Data Extract
  • Copying
  • Create Extract Macros
    • Simplified Extract Macro Workflow
    • Attributes of a SQL Macro
    • Example
    • Macro Data Type
    • Some SQL*Plus Functions
    • Some Examples of SQL and SAS Macros
    • Some Hints for SAS Users
    • Defining Extract Macros Using the Maintain Extract Macros Window
    • Changing a Macro Definition
    • Listing Available Functions in the Database
  • Creating Key Templates
    • Maintain/Query Key Templates
    • Customize/Query Key Template Columns
    • Order Specification for Data Viewing
    • Aggregation
  • Create Questions and View Templates
    • Associating Questions with Views
  • Maintaining View Definitions
    • Linking a View Definition to a DCM
    • Viewing the Data for a View Definition
    • View Model
    • Creating View Templates
    • Mapping DCM Questions to View Template Questions
    • Having Clauses
    • Copying a View Definition
  • Defining Study Sets
  • Creating Union Views
    • Creating a Cross-study Union
    • Troubleshooting Cross-study Union Views
    • Creating In-Study Union Views
    • Example of Union Views
  • Creating Where Clauses
    • Copying Where Clauses
  • Adding DISTINCT terms
  • About Joining Fast Extract Views
  • General Example

15 Lab Ranges

• Establishing Units of Measure
  • Defining Lab Units
  • Defining lab test Question Units
  • Defining Unit Conversions
    • Testing a Lab Conversion Calculation
  • Defining Preferred Conversion Groups
• Defining Standard Lab Ranges
  • Defining Textbook Ranges
  • Defining Preferred Copy Groups
  • Defining Lab Panels
  • Defining Labs
  • Defining Specific Lab Ranges
    • Age
    • Effective Date
    • Lab Range Records without Effective Start or Effective End Dates
    • Defining Lab Ranges Using the Maintain Lab Ranges Window
  • Defining Lab Subsets
    • Defining the Subset Name
    • Defining the Subset Range Values
  • Using Textbook Ranges
  • Copying Lab Ranges
• Lab Assignment Criteria
  • Example of Lab Assignment Criteria Evolution
  • Applying Lab Assignment Criteria
    • Granting Privileged Update to a User
  • Resolving Problems
    • Missing Lab References in the RDCMs
    • Missing Data in Patient Positions
• Batch Loading Lab Ranges
  • Loading Data
    • File Format
    • Example
  • Validating Data
  • Transferring Data
    • Example
  • Executing the Process
  • Running the Lab Procedures Re-execution Pre-Process Batch Job

16 Validation and Derivation Procedures

• About Validation Procedures
  • Examples of Validation Procedures
    • Simple Validation Procedure
    • Validation Procedure with an Arithmetic Function
    • More Complex Validation Procedure
• About Derivation Procedures
  • Restrictions on Derivation Procedures
  • Examples of Derivation Procedures
• Overview of Defining a Procedure
• How Procedures Work Internally
  • Cursors
    • Patient Information Cursors
    • Procedure Question Group Cursors
  • Structure of Procedure PL/SQL Programs
    • Example: Procedure with More Than One Procedure Question Group
    • Example: Procedure Containing One Procedure Question Group
    • Example: Procedure with Multiple DCMs
    • Sort Order
    • Sample Procedure Code, with Custom Code Locations
  • Viewing Generated PL/SQL Code
• Special Processing
  • Correlation
    • Correlation on Event
    • Correlation by Qualifying Value
    • Correlation by Question Value
    • Restrictions
    • Setting Up Correlation
  • Aggregate Functions
    • Variable Names
    • Restrictions
    • Setting up Aggregate Functions
  • Aggregate Lag Functions
    • Variable Names
    • Restrictions on Aggregate Lag Functions
    • Using Aggregate Lag Functions
  • Lag Checks
    • Variable Names
    • Setting Up Lag Checks
    • Lag Check Examples
  • Where Clause Extension
  • Qualifying Expression
  • Custom Code
• Procedure Variables
  • Question Variables
  • Aggregate and Lab Attribute Variables
    • Aggregate Variables
    • Lab Attribute Variables
  • System Variables
    • Standard Variables
    • Question Group Variables
    • DVG Variables
  • User Variables
• Using Lab Ranges
• Defining Validation and Derivation Procedures
  • Where to Start
    • Creating an Entirely New Procedure
    • Creating a New Version of a Procedure
    • Modifying an Existing Procedure
  • Procedure Definition Sequence
  • Naming and Describing a Procedure
    • Access Privileges
    • Defining a Procedure
  • Defining Procedure Question Groups
    • Performance Issues
    • About the Question Groups Window
  • Defining Procedure Questions
  • Defining Correlating Questions for Procedure Question Groups
  • Defining User Variables
    • Variable Name
    • Init Alias
    • Data Type
    • Length
    • Decimal Places
    • Initial Value
    • Report
    • Description
  • Defining Procedure Details
    • Order Number
    • Continue If Discrepancy
    • Test Not Null Only
    • Detail Types
    • Externally Derived
    • Failure Type
    • Description
    • Expression
    • Message
    • Discrepancy Code
  • Using System Variables in Pre-v3.1-Style Procedures
  • Using Variables in V3.1-Style Procedures
    • Variable
    • Perform Detail Only If...
    • Discrepancy Test
    • Report
    • Report Order
  • Adding Custom Code
    • Adding Custom Code
• Testing and Activating Procedures
  • Generating and Compiling a Procedure
  • Editing Generated PL/SQL Code
  • Testing a Procedure
    • Testing a Procedure from Definition
    • Testing a Procedure from Test a Study
  • Assigning Procedure Status
  • Assigning Standards Affiliation
• Executing Procedures
  • Executing a Single Procedure
    • Execute a Single Procedure from the PSUB Window
    • Execute a Single Procedure from the Procedures Window
  • Executing Batch Validation
    • Facts About Procedure Execution During Batch Validation
    • Batch Validating TMS Derivation Procedures
    • Procedures and Frozen-status Patients
• V3.1-Style and Pre-V3.1-Style Procedures
  • V3.1-Style Procedure Enhancements
  • Converting to the V3.1 Style
    • Conversion Example
  • Creating a New Pre-V3.1-Style Procedure
• Maintaining Patient Statuses
  • Populating the Patient Statuses Table
    • Example
  • Patient Synchronization
    • Procedure Definition
  • Example
  • Pre-Details Custom Code
  • Alternative Approaches to Error Reporting
    • Single Failure
    • Multiple Failure
  • Type Coercion and Comparison of Derived Values

17 Test Mode

• Overview
  • A Typical Test Mode Workflow
  • How Test Data and Production Data Differ
  • Test Mode Limitations
• Launching Test Mode Sessions
• Setting Up Test Study Design
  • About Test Mode Synonyms
• Creating and Loading Test Data
  • Creating Test Data
  • Batch Loading Test Data
  • Using Test Mode Batch Data Delete
• Testing Definitions
  • Testing Validation Procedures
  • Testing Derivation Procedures
  • Batch Validating Test Data
  • Testing Layouts in Oracle Clinical
  • Testing Layouts in Remote Data Capture (RDC) Classic
  • Testing Layouts in Remote Data Capture (RDC) OnSite
  • Testing in Debug Mode
  • Checking Validation Results
  • Testing Mass Changes
  • Testing Data Extract Views

18 Integrating with a Clinical Trial Management System

• Enabling Patient and Subject Activity Integration
  • Enabling Integration at the Database Level
  • Overriding Default Integration Values for Individual Studies
• Setting Up and Using Activity Completion Integration
  • Creating Activity Completion Criteria
  • Adding Activity Completion Criteria Details
  • Running the Track Activities Batch Job
  • Completion Criteria Processing
    • Completeness Logic
    • Completion Date Updates

A Flexible Study Design Examples

• Basic Examples
  • Enabling a DCI within a Clinical Planned Event
  • Enabling DCIs Across Clinical Planned Events
  • Enabling Intervals Based on the Collection of Any Data
  • Enabling Intervals Based on a Data Value
  • Skipping to an Interval
  • Enabling the Next Interval
• Complex Examples
  • Defining Multiple Paths Through a Trial
  • Enabling DCIs in a Conditional Interval
  • Defining Multiple Conditional Pretreatment Intervals and DCIs

Index