Study Setup User Guide

Release 5.1.0

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Feb 01, 2019

Abstract

This guide describes the general process of defining a study database in DFdiscover and specifically the use of DFsetup to assist in study definition.


Table of Contents

Preface
1. Introduction
1.1. Study Setup - Components
1.2. Study Setup - Step by Step
1.3. Study Setup - Testing
1.3.1. User Permissions
2. Using DFsetup - An Overview
2.1. Login
2.2. Access Modes
2.3. Certificate Info
2.4. Main Window - CRFs
2.4.1. Modifying the appearance with keyboard shortcuts
2.5. Main Window - Field List
2.6. Entering Study Setup Specifications
2.7. Menus
3. Defining Data Fields
3.1. Preparation
3.2. Module and Field Definition
3.2.1. Key Fields
3.2.2. CRF Field Properties
3.2.3. Arbitrary CRFs
3.3. Field Location
3.4. Creating New Fields by Copy & Paste
3.5. Reordering Data Fields, Screens and Grouping
3.6. Modifying Plates that Contain Data
3.7. Adding & Deleting Plates
3.8. Modifying Style, Module & Field Definitions
3.9. Modifying a Data Entry Widget
3.10. eSignature Module and 21 CFR Part 11 Compliance
3.10.1. Requiring eSignature on a Plate
3.10.2. Signing with the eSignature Module in DFexplore
4. Field Menu
4.1. Copy
4.2. Paste
4.3. Delete
4.4. Select All
4.5. Order
4.6. Group
4.7. Ungroup
5. File Menu
5.1. Preferences
5.2. Link
5.3. Print
5.4. Save as PDF
5.5. Save
5.6. Export Setup
5.6.1. Excel Output
5.7. Verify All
5.8. Review Changes
5.9. New Study
5.10. Close Study
5.11. Exit
6. Study Menu
6.1. Global Settings
6.1.1. Global view
6.1.2. Help view
6.1.3. Fields view
6.1.4. Levels view
6.1.5. Guides view
6.2. Import CRFs
6.3. Import Definitions
6.4. Add eCRF Plate
6.5. Modify Plate Number
6.6. Delete Plate
7. View Menu
7.1. Modules
7.2. Plates
7.3. Styles
7.3.1. Common Properties
7.3.2. Type Specific Properties
7.3.3. Edit Coding Table
7.4. Edit checks
7.5. Lookup Tables
7.6. General Dialog Controls
7.7. Sites
7.7.1. Site Specifications
7.8. Missing Value Codes
7.9. Query Category Map
7.10. Sort Map
7.11. Lookup Tables Map
7.12. Visit Map
7.13. Page Map
7.14. CRF Type Map
7.15. CRF Background Map
7.16. Conditional Terminations
7.17. Conditional Cycles
7.18. Conditional Visits
7.19. Conditional Plates
7.20. Query Titles
7.21. Query Covers
7.22. Query Messages
8. Subject Visit Scheduling
8.1. Introduction
8.2. Visit Dates
8.3. Visit Map
8.4. Cycles
8.4.1. The Screening Cycle
8.4.2. In-Study Cycles
8.4.3. The End Cycle
8.4.4. Cycle Specifications
8.5. Visits
8.5.1. Visit Number
8.5.2. Visit Type
8.5.3. Visit Label
8.5.4. Due Day
8.5.5. Overdue Allowance
8.5.6. Visit Date Location
8.5.7. CRF Plates
8.6. Display Order
8.7. Visit Map Examples
8.8. Conditional Maps
8.8.1. Conditional Cycle Map
8.8.2. Conditional Visit Map
8.8.3. Conditional Plate Map
8.8.4. Conditional Termination Map
8.9. Early Termination Plates
8.10. Missed Visit Plates
8.11. Implementation & Scheduling Rules
8.12. DF_QCupdate
8.13. Termination of Subject Follow-up
8.14. Effect of Early Termination on Visit Requirements
8.15. Identification of Missing Plates
8.16. Conditional Cycles and Conditional Visits
9. CRF Design Guidelines
9.1. Introduction
9.2. CRF Plates
9.3. Barcodes
9.4. Key Fields
9.4.1. Study Number
9.4.2. Plate Number
9.4.3. Visit/Sequence Number
9.4.4. Subject ID
9.5. Visit Dates
9.6. General CRF Design Guidelines
9.6.1. Font and Point Size
9.6.2. Line Weight
9.6.3. Box Size and Position
9.6.4. Lines and Decorations
9.6.5. CRF Instructions
9.7. Supported Field Types
9.7.1. Check
9.7.2. Choice
9.7.3. Numeric
9.7.4. Date
9.7.5. Time
9.7.6. Text
9.7.7. Visual Analog Scales (VAS)
9.8. Printing
9.9. CRF Design Limits
A. Appendix
A.1. Data Types
A.2. Setup & Database Limits
A.3. UNICODE Support
A.4. Meta-Words
A.5. Conditional Tests
A.6. External Software Copyrights
A.6.1. DCMTK software package
A.6.2. Jansson License
A.6.3. HylaFAX Facsimile Software
A.6.4. Mimencode
A.6.5. RSA Data Security, Inc., MD5 message-digest algorithm
A.6.6. mpack/munpack
A.6.7. TIFF
A.6.8. PostgreSQL
A.6.9. OpenSSL License
A.6.10. Original SSLeay License
A.6.11. gawk
A.6.12. Ghostscript
A.6.13. MariaDB and FreeTDS
A.6.14. QtAV
A.6.15. FFmpeg
A.6.16. c3.js
A.6.17. d3.js