1. REDCap Treatment Randomization ModuleBy
J Kevan Essmyer
Acknowledgements:
Paul Harris (Vanderbilt CTSA)
Jack Baty (WUSM REDCap Admin)

2. Overview What is it… Where is it… What are the costs…
REDCap Features (A brief tour of the system)…
Getting Started (Creating a REDCap project)…
Demonstration…

3. Need for Data Capture Software
Convenient uniform data entry method
Stateless web-based
Secure WUSM HIPAA compliant centralized data store.
Easy to use multi-purpose clinical database
Not Excel, Not Access, Not 3-4 composition notebooks somewhere on the top shelf
Reduce data “cleaning” effort during analysis.

4. REDCap System (What is it?)
Easy to use, web based Research data capture system
Metadata (Form) driven data store development
Generic clinical data system with adaptable features covering Surveys, Cross-sectional, and longitudinal study models
Provides data validation at time of entry, and user based data access restrictions.
Provides easy mechanism to view and export data in a variety of formats for common analysis tools.
Designed to be a self service tool

5. Biostatistics Secure Domain
Public HTTPS Survey Access
Biostatistics Secure Domain
WEB Server
File Server
REDCap Survey
Uploaded Files
MySQL Server
Authenticated Access
Data
WEB Server
Sync
WU Campus
Data Entry /Admin
MySQL Slave Server
Data Entry /Admin
Sidedoor Server
Installation Files
Host Server

6. WUSM REDCap Servers (http://www.biostat.wustl.edu/redcap)
Development “Trying it Out”
HIPAA Secure server
REDCap User Request form (Fax or )
Sponsoring PI
Username /password
Open access to the Development server
Off-campus Access
Sidedoor security certificate
Access from any “capable” Internet connection (world wide)
Production “Data Collection”
REDCap Project Request form (Fax or )
Sponsoring PI
IRB Approval or Waiver
Only PI or Project Admin can create projects
Production “Status”
Data Dictionary
Changes saved
Review of submitted changes to avoid unintended data corruption
Delete all records function disallowed

7. Move to Production Status
“Production Status” on the Production Server
Data dictionary changes are stored by the system
Global deletion of data from system prohibited
“High Risk” changes to forms must be approved by Administrators before they are committed to the project.
Changes to the Forms/ Event Grid
Events may be added but not removed

8. Current Usage Costs
Offered as an Investigator Resource for Washington University Institute of Clinical and Translational Sciences(ICTS) and Siteman Cancer Center (SCC) members.
No charge for data or file storage.
File size currently limited to 32MB per file
No limit on the number of projects per study.
Basic technical support and usage guidance provided by REDCap adminstators.

9. Treatment Randomization Module
Stratified Randomization
Use up to 14 project fields
Multiple Choice fields
Group Stratifications
Data Access groups
Designated Multiple Choice Grouping Field
Randomization Template
Generated based on selected criteria
Development and Production Tables
Once in Production status treatment Allocation tables are locked

10. Enable Randomization Feature in Project Settings

11. Set up Randomization on Project Setup Screen

12. Randomization User Rights
Randomization Rights
Setup up allocation tables
Create and load Trt allocation tables
View current randomization Status
Check progress of randomization
Randomize Participant

13. Treatment Randomization Module

14. Select and Save Criteria

15. Download Allocation Table Template
Example allocations !!
You will need to assign your treatment allocations based on your project’s statistical analysis plan

16. Upload Allocation Tables
Duplicate allocations !!
You may not use the exact same allocation table for Production status that you used in Development status

17. Randomize Participant

18. Randomization Dashboard

19. Getting Started Enable Randomization Select Fields
Select Data Entry Forms project
Set “User Rights” for users who will administer and setup the randomizations
Select Fields
Up to 14 strata fields
Set grouping if applicable
Set Treatment Field
Allocation Templates
Save randomization model
Download Allocation templates and replace content according to study protocol
Upload Development/Production allocation tables
Tables become locked once project is put into Production Status
Randomization fields clear
Monitor Randomization
Dashboard

20. “?!!?” Branching Logic Data Validation User Rights API Data Dictionary
Scheduling
Data Dictionary

21. REDCap Lifelines Built-in tutorial videos
Built-in Frequently Asked Question (FAQ) guide
Demonstration Databases (Some Online, more to come)
WUSM Biostat REDCap Help Queue
Monitored by 4 to 5 Administrators

22. REDCap Support

23. REDCap Goals Questions? Easy to use Metadata Driven Adaptable Features
Data entry validation
Self service tool
Questions?