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Oracle® Clinical Creating a Study
Release 5.0
E36996-01
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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
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
Options in Group Verify dialog
Options in Group Approve dialog
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) 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