DFexplore User Guide

Release 5.1.0

All rights reserved. No part of this publication may be re-transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of DF/Net Research, Inc.. Permission is granted for internal re-distribution of this publication by the license holder and their employees for internal use only, provided that the copyright notices and this permission notice appear in all copies.

The information in this document is furnished for informational use only and is subject to change without notice. DF/Net Research, Inc. assumes no responsibility or liability for any errors or inaccuracies in this document or for any omissions from it.

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Feb 01, 2019

Abstract

This guide describes the DFexplore application.

The instructions are intended to describe, in general terms, how data management tasks are performed using DFexplore. The guidance provided here is not meant to replace more specific instructions which may be provided by the sponsor, principal investigator or coordinating site for a particular trial.


Table of Contents

Preface
1. Introduction
1.1. What is DFexplore?
1.2. What type of computer do I need?
1.3. What type of web browser do I need?
1.4. Is data transmission over the internet secure?
1.5. What kind of response time can I expect?
1.6. How complicated is this going to be?
1.7. Is any subject data stored on my local hard drive?
1.8. Can anyone impersonate me within DFexplore?
1.9. What if I forget my password?
1.10. How hard is it to navigate among the various study forms for each subject?
1.11. Can I use DFexplore for more than one study at a time?
1.12. If I don't like this, or don't have time for it, can I switch to another method of data collection / entry?
1.13. How do I get started?
1.14. After I connect to a study how do I enter subject data?
1.15. What do I do when I'm finished entering subject data?
2. A Guided Tour
2.1. Login
2.2. Authenticating
2.3. Selecting a Study
2.4. User Permissions
2.5. Dashboard View
2.6. Data View
2.7. Queries View
2.8. Reasons View
2.9. Image View
2.10. Reports View
2.11. Schedule View
2.12. Status View
2.13. List View
2.14. Batch Edits View
3. Using DFexplore
3.1. How do I select the correct subject binder for a new subject?
3.2. Can I print a copy of a subject binder?
3.3. How do I confirm that I am the only person making changes?
3.4. How can I make sure that I am completing the data forms correctly?
3.5. Can I enter a reason to explain an unusual value or a value that I have changed?
3.6. Can I use standard missing value codes?
3.7. What are queries and where do they come from?
3.8. How do I find all outstanding queries?
3.9. How do I respond to queries?
3.10. Can I respond to a query by adding a reason for the data value?
3.11. How should I respond to a query if the data field is correct as is?
3.12. Can I indicate that a subject visit is unavailable?
3.13. Can I indicate that a page is unavailable?
3.14. Do I need to save the changes I have made?
3.15. Can I undo all changes I just made to a page?
3.16. What is the best way to find all outstanding problems?
3.17. Why did my DFexplore session Auto Logout?
3.18. How do I exit from DFexplore?
3.19. What should I do if I have questions?
4. Dashboard View
4.1. Customize Dashboard Contents
4.2. Shortcuts
4.3. Database Status Summary
4.4. Study Help
5. Data View
5.1. Subject Binders
5.1.1. Subject Icons
5.2. Metadata: Queries, Reasons and Missing Values
5.3. Data Field Colors
5.4. Entering Data and Metadata
5.5. Saving Data and Metadata
5.6. Correcting Key Fields
5.7. Images of CRFs and other documents
5.8. Image Option Buttons
5.9. High Definition (HD) Images Setting
5.10. Working with Tasks
5.10.1. Performing Tasks
5.10.2. Defining Tasks
5.10.3. Task Definition Examples
5.10.4. Task Definition by Program
5.10.5. Task Definition by Edit Check
5.11. Ad hoc Record Selection
5.11.1. Changing Mode and Level
5.11.2. Select - By Data Fields
5.11.3. Select - By Data Retrieval File
5.11.4. Select - Batch Validate
5.12. Using Lookup Tables
5.13. Query Management
5.13.1. Automatic Resolution of Data Queries
5.14. Review/Approve Queries and Reasons
5.15. Transmitting Scanned CRFs
5.15.1. Limitations in Submit PDF
5.16. Importing Subject CRFs
5.16.1. Spreadsheet Keyboard Shortcuts
5.17. Creating Subject Packages
5.18. Data View Menus
5.18.1. File Menu
5.18.2. Edit Menu
5.18.3. Select Menu
5.18.4. Show Menu
5.18.5. Subject Menu
5.18.6. Visit Menu
5.18.7. Plate Menu
5.18.8. Field Menu
5.18.9. Window Menu
5.18.10. Help Menu
6. Queries View
6.1. The Queries Table
6.2. Query Status
6.3. Queries View Menus
6.3.1. The Show Menu
6.3.2. The Query Menu
7. Reasons View
7.1. The Reasons Table
7.2. Reason Status
7.3. Reasons View Menus
7.3.1. The Show Menu
7.3.2. The Reason Menu
8. Image View
8.1. The Record Selection Dialog
8.2. Entering New Records
8.3. Entering Resubmitted CRFs
8.4. High Definition (HD) Images Setting
8.5. Correcting the Keys
8.6. Switching to Data View
8.7. Record Locking in Image View
8.8. Image View Menus
8.8.1. The Select Menu
8.8.2. The Plate Menu
9. List View
9.1. Introduction
9.2. User Preferences
9.3. Navigation
9.4. Working on a Task
9.5. Selecting Data Fields
9.6. Searching Data Records
9.7. Functions
9.8. Saving Defined Views
9.9. Exporting Data Records
9.9.1. Metadata Output Options
9.10. Exporting a Data Retrieval File
9.11. Exporting SAS Data Sets
9.12. Importing Data Records
9.13. Metadata - Queries, Reasons, Query Reports and Missed Records
9.14. List View Menus
9.14.1. File Menu
9.14.2. Select Menu
9.14.3. Show Menu
10. Reports View
10.1. Introduction
10.2. Report Types
10.3. Explain - Report Documentation
10.4. Tabbed and Docked Windows
10.5. Interactivity
10.6. Report Options and Database Permissions
10.7. Running Reports
10.7.1. Running Reports outside of DFexplore
10.8. Saving Report Lists
10.9. Report Output Formats
11. Schedule View
11.1. Features
11.2. Interactivity
11.3. Filtering Results
11.4. Differences Between Schedule View and DF_QCupdate
12. Status View
12.1. Introduction
12.2. Level & Status
12.3. Filtering The Status Report
12.4. Links
12.5. User Permissions
12.6. Image Queue
12.7. Image Router
13. Batch Edits View
13.1. Introduction
13.2. Batch Control
13.3. Batch Definition
13.4. Batch Results
14. Image Router
14.1. Introduction
14.2. Router Functions
14.3. Restrictions
14.4. Starting Image Router
14.5. File Menu
14.5.1. Refresh
14.5.2. New Study
14.5.3. Close Image Router
14.6. Page Menu
14.6.1. Rotate
14.6.2. Shift
14.6.3. Flip
14.6.4. Cut
14.6.5. Truncate Length
14.6.6. Trim Width
14.6.7. Rotate 90° CW/CCW
14.6.8. Rotate 90° CW/CCW and scale
14.6.9. Print
14.6.10. Export as PDF
14.6.11. Previous
14.6.12. Next
14.6.13. Context
14.6.14. Reset
14.7. Action Menu
14.7.1. Rotate/Shift/Identify
14.7.2. Move
14.7.3. Discard
15. User Settings
15.1. User Profile, Change Password
15.2. Session Settings
15.3. User Preferences
15.3.1. Default View
15.3.2. Data Window
15.3.3. Image Window
15.3.4. Record List
15.3.5. Query Defaults
15.3.6. List View
15.3.7. Image View
15.3.8. Reports View
15.3.9. Background Options
15.3.10. Auto Logout
A. Terminology, Shortcuts, Acknowledgements and Copyrights
A.1. Terminology
A.2. DFexplore Keyboard Shortcuts
A.3. Common Error and Warning Messages
A.4. Programs
A.4.1. DFmkdrf.jnl - make DFdiscover DRF file from study journals
A.4.2. DFmkdrf.ec - make DRF file from edit checks
A.5. Selecting Subjects based on Criteria
A.6. CDISC ODM Export
A.7. External Software Copyrights
A.7.1. DCMTK software package
A.7.2. Jansson License
A.7.3. HylaFAX Facsimile Software
A.7.4. Mimencode
A.7.5. RSA Data Security, Inc., MD5 message-digest algorithm
A.7.6. mpack/munpack
A.7.7. TIFF
A.7.8. PostgreSQL
A.7.9. OpenSSL License
A.7.10. Original SSLeay License
A.7.11. gawk
A.7.12. Ghostscript
A.7.13. MariaDB and FreeTDS
A.7.14. QtAV
A.7.15. FFmpeg
A.7.16. c3.js
A.7.17. d3.js