openCDMS


Table of Contents

1. Introduction
2. Installation and Removal of Software
Obtaining a openCDMS user name and password
openCDMS Systems
NHS system
MHRN public internet system
"Test" system
Java WebStart Software
Preparation and Prerequisites
Installation
Uninstallation
Re-installation
3. openCDMS Collect
Introduction
Basic concepts and terminology
Glossary of Terms
Overview of Core Concepts
Overview of the Collect Application User Interface
The Application at a Glance
Introduction to the Participant View
Introduction to the Document View
The Application Menu
Collect Functionality - a 'How To' Guide
Creating a new record for a participant
Opening Existing Participants
Document Data Entry
Data Entry Shortcuts
Saving Documents
Moving Documents through the Work Flow
Committing Data to the Database
Viewing/Editing Participant Record Properties
Integration with the Participant Register
Data Replication
Printing documents
Exiting Collect
Problem Reporting
4. openCDMS Control
Definition of Roles
Viewing the current status of studies, users and roles
Add User
Modify User
Delete User
Change Password
Right-Click Menu
File Menu
Tools Menu
Help Menu
Toolbar
5. openCDMS Create
Wizard Set-up
Wizard Page One - Study Identifiers and Properties
Wizard Page - Study Stages
Documents
StudySchedule
Menus
File Menu
Study Menu
Help Menu
Main Design Window Overview
Tree Views
The Document Panel
The Entry Panel
Configuration of Documents
Document Properties
Document Sections
Configuration of Entries
Basic Entries Properties
Manage Units
Manage Validation Rules
Manage Transformers
Collaborative Study Editing
Study Statuses and Valid Next Statuses
Participant Register
Randomization
Strata
Treatments
Block sizes
Randomization Emails
Randomisation Trigger
Reporting
Validate Study
Manage Import Maping
Autosaving
Glossary
Study
Document
Section
Entry
Centre
Site
Study Stages
Transformers
Units
Validation Rules
Roles
Status
State Transitions
Consent Form
Database
Library
Overview
Elements explained
Saving elements from a study
Importing elements into a study
The Library View
Library Information Dialog
6. openCDMS Web
Accessing openCDMS Web
Data Export
Requesting an export
Viewing requests and downloading exports
Reporting
Individual Record Reports
View Trends
Project Management
Participant Register
Selecting a Study and Centre
Participant Identifier by Details
Details by Participant Identifier
Updating the Personal Details for a Participant
Treatment Arm by Participant Identifier
Treatment arm by details
Emergency Break-in
Treatment arm statistics
Change Password
Logging Off
Problem Reporting
7. Support
E-mail
Phone
Password change
Lost Password
Choosing a secure password

List of Figures

2.1. Certificate dialog
2.2. Certificate Import Wizard dialog (1)
2.3. Certificate Import Wizard dialog (2)
2.4. Certificate Import Wizard dialog (3)
2.5. Security Warning dialog
2.6. Certificate Import Wizard success dialog
2.7. Security Alert dialog
2.8. Java Loading
2.9. Create shortcuts dialog
2.10. Login dialog
2.11. LAN Settings Dialog
2.12. Application Settings dialog
2.13. Change Proxy Settings dialog
2.14. Proxy Setting Dialog
2.15. Control Panel
2.16. User Accounts
2.17. Enter Proxy Credentials
2.18. Java Spash Screen
2.19. Webstart Error Message
2.20. Windows Start menu
2.21. Run dialog
2.22. Java Control Panel
2.23. Java WebStart Network Settings
2.24. Java not installed dialog
2.25. Wrong java version installed (1)
2.26. Wrong java version installed (2)
2.27. Run dialog
2.28. Java Cache Viewer
3.1. Review and approve cycle
3.2. Implicit Flow Diagram
3.3. Setting Connectivity Mode
3.4. Collect application overview
3.5. Collect - Participant View
3.6. Participant Window - Document Icons
3.7. Document View
3.8. Toolbar
3.9. File menu
3.10. Database menu
3.11. Print menu
3.12. Advanced menu
3.13. Options menu
3.14. Help menu
3.15. Select study dialog
3.16. Participant Identifier dialog - specify study-level details
3.17. Consent dialog
3.18. Choose Participant Dialog
3.19. Data entry screen - validation error on entry
3.20. Data entry screen - validation error in section
3.21. Single-line text entry field
3.22. Text entry field - select missing code
3.23. Text entry field - with missing code
3.24. Multi-line text entry field
3.25. Date entry field - calendar
3.26. Date entry field - date
3.27. Date entry field - partial date (1)
3.28. Date entry field - partial date (2)
3.29. List of options entry field (1)
3.30. List of options entry field (2)
3.31. Calculated field
3.32. Externally calculated field
3.33. Tabular data entry
3.34. Disabled fields (1)
3.35. Disabled fields (2)
3.36. Choose Missing Code dialog
3.37. Import document (1)
3.38. Import document (2)
3.39. Problem Saving Document dialog
3.40.
3.41. Mark entry as invalid
3.42. Enter annotation dialog
3.43. Edit Entry dialog
3.44. Review amended document
3.45. View provenance dialog
3.46. Commit dialog
3.47. View/Edit Record Properties
3.48. 'Record Properties' Dialog
3.49. Participant Register dialog
3.50. Participant Register - could not upload message
3.51. Participant Register - Open Participant
3.52. Participant Register - View/edit Participant Menu
3.53. Randomize dialog
3.54. Randomization failed dialog
3.55. Link records dialog
3.56. Link records - secondary record participant identifier
3.57. Complete document in both primary and secondary dialog
3.58. Complete documents in the secondary record that aren't in the primary dialog
3.59. Complete documents in the secondary, incomplete in the primary dialog
3.60. Incomplete documents in the secondary will be moved to the primary dialog
3.61. Document cannot be created dialog
3.62. Unexpected problem dialog
4.1. List of users
4.2. Control toolbar
5.1. Study Designer main window
5.2. Section Edit Dialog
5.3. Configure Option Entry dialog
5.4. Add Option dialog
5.5. Configure Entry - Option Dependencies
5.6. New Dataset Configuration Dialog - Statuses and Transitions
5.7. Add status dialog
5.8.
5.9. Manage Participant Register dialog
5.10. Library search dialog
5.11. Opening the Library View
5.12. Element Submission Dialog
6.1. openCDMS web login page
6.2. Data Export main screen
6.3. Data Export - Request export (1)
6.4. Data Export - Request export (2)
6.5. Data Export - Request export (3)
6.6. Data Export - Request export (4)
6.7. Data Export - view export requests
6.8. Reports main screen
6.9. Record report (1)
6.10. Record report (2)
6.11. Record report (3)
6.12. Record report (4)
6.13. Record report (5)
6.14. Trends report (1)
6.15. Trends report (2)
6.16. Trends report (3)
6.17. Trends report (4)
6.18. Trends report (5)
6.19. Trends report (6)
6.20. Trends report (7)
6.21. Example trends report
6.22. Management Report (1)
6.23. Management Report (2)
6.24. Participant Register - Select study and centre
6.25. Participant Register - Find study number
6.26. Participant Register - Find personal details
6.27. Participant Register - Details and Participant Identifier
6.28. Participant Register - Update personal details
6.29. Participant Register - Find treatment arm by participant identifier
6.30. Participant Register - Treatment arm
6.31. Participant Register - Find treatment arm by details
6.32. Participant Register - Emergency break in
6.33. Participant Register - Allocation statistics
6.34. Change password screen
6.35. Error screen

List of Tables

2.1. URLS for root certificates
2.2. URLs for downloading openCDMS software
3.1. Data replication conflicts
4.1. Role definitions
6.1. openCDMS Web URLs