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Contents
Title and Copyright Information
Preface
Audience
Documentation Accessibility
Finding Information and Patches on My Oracle Support
Finding Oracle Clinical Documentation
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
9.3.8
Defining Custom Reviews Required at the DCI 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
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