Table of Contents
- Title and Copyright Information
- Preface
- 1 Overview of Creating a Study
-
Part I Designing Studies
-
2
Planning and Designing a Study
- Maintaining Programs
- Defining Projects
- Assigning Compounds
- Creating Organization Units
- Maintaining 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
- Setting Up Partial Source Data Verification
- Designing a Flexible Study
- Using Oracle Clinical-Siebel Clinical Integration
- Copying Clinical Studies
- Planning Study and Site Enrollment
- Creating a New Study Plan
- Study Site Plans
- Maintaining Clinical Study States
- 3 Easy Study Design
-
4
Sites, Investigators, and Patient Positions
- Maintaining Site Records
- Maintaining Investigator Records
-
Maintaining Patient Positions
- Creating Patient Positions
- Marking Patients Eligible for Source Data Verification
- Assigning Patient Positions to Sites
- Changing Owning Locations
- Retrieving Patient Positions
- Deleting Patient Positions
- Enrolling Patients in a Study
- Linking Patient Positions in Different Studies
- Assigning Patient Positions to DCI Books
- Treatment Assignments
- Blind Breaks
-
5
Treatments and Schedules
-
Treatments
- Maintaining Active Substances
- Maintaining Drugs
- Maintaining Single Treatment Regimens
- Creating or Modifying a Single Treatment Regimen
- Maintaining Daily Dosage Details for a Treatment Regimen
- Maintaining Combined Treatment Regimens
- Maintaining Patterns
- Maintaining Treatment Patterns
- Maintaining Treatment Pattern Codes
- Defining a Study Schedule
- Creating Clinical Planned Events
-
Treatments
-
6
Stratification and Randomization
- Stratification
- Randomization
-
Randomization Maintenance
- Replicating a Randomization
- Mirroring Randomization
- Maintaining Randomization Statuses
- Creating or Revoking an Access View
- Cohort Views
-
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
-
2
Planning and Designing a Study
-
Part II Defining Data Collection Objects
-
7
Questions and Question Groups
- Creating and Maintaining Questions
- Creating and Maintaining Question Groups
- Creating and Using DVGs
-
8
Global Library Activities
- Storing Objects in the Global Library
- Maintaining Domains
- Maintaining Standards Affiliations
- Maintaining Global Library Copy Groups
-
9
DCMs and DCIs
-
Defining DCMs
- Generating Layouts from 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
- Defining Conditional Branching
- Using Normalized Lab Data
- Defining Date Formats
- Scheduling DCMs
- Creating Character-Based Layouts
- Defining DCIs
-
Defining DCMs
-
10
Defining DCI Books
- Traditional and Enhanced DCI Books
- Defining an Enhanced DCI Book
- Calculating DCI and Interval Expectedness for Patients
- Data Entry and Expectedness
- Assigning Patients to a DCI Book
- Defining a Traditional DCI Book
- Using CRF Page Tracking
- 11 Annotating CRFs
-
12
Creating Graphic Layouts
- Creating a DCI Form
- DCI Form Layout Areas
- 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
- Source Data Verification Plan Defaults
-
Configuring Local Studies
- Configuring DVGs and DCI Modules
- Maintaining DCM Graphic Layouts
- Maintaining DCI Graphic Layouts
- Maintaining Form Layout Templates
- Editing Layouts
- Creating and Maintaining Conditional Blocks
- Troubleshooting Graphic Layout Problems
- 13 Copy Groups
-
14
Data Extract
- The View Builder's Structure
- 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
- Create Questions and View Templates
- Maintaining View Definitions
- Defining Study Sets
- Creating Union Views
- Creating Where Clauses
- Adding DISTINCT terms
- About Joining Fast Extract Views
- General Example
- 15 Lab Ranges
-
16
Validation and Derivation Procedures
- About Validation Procedures
- About Derivation Procedures
- Overview of Defining a Procedure
- How Procedures Work Internally
- Special Processing
- Procedure Variables
- Using Lab Ranges
-
Defining Validation and Derivation Procedures
- Where to Start
- Procedure Definition Sequence
- Naming and Describing a Procedure
- Defining Procedure Question Groups
- Defining Procedure Questions
- Defining Correlating Questions for Procedure Question Groups
- Defining User Variables
- Defining Procedure Details
- Using System Variables in Pre-v3.1-Style Procedures
- Using Variables in V3.1-Style Procedures
- Adding Custom Code
- Testing and Activating Procedures
- Executing Procedures
- V3.1-Style and Pre-V3.1-Style Procedures
- Maintaining Patient Statuses
- 17 Test Mode
- 18 Integrating with a Clinical Trial Management System
-
7
Questions and Question Groups
- A Flexible Study Design Examples