REDCap Treatment
Randomization Module
By
J Kevan Essmyer
Acknowledgements:
Paul Harris (Vanderbilt CTSA)
Jack Baty (WUSM REDCap Admin)
Overview
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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…
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.
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
Public HTTPS Survey Access
Biostatistics Secure Domain
WEB Server
File Server
Authenticated Access
Sync
MySQL Server
WU Campus
Sidedoor
Server
Data Entry /Admin
WEB Server
MySQL Slave Server
Host Server
WUSM REDCap Servers
(http://www.biostat.wustl.edu/redcap)
Development “Trying it Out”
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HIPAA Secure server
REDCap User Request form (Fax or
email)
– 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”
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REDCap Project Request form (Fax or
email)
– Sponsoring PI
– IRB Approval or Waiver
– Only PI or Project Admin can
create projects
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Production “Status”
– Data Dictionary
• Changes saved
• Review of submitted
changes to avoid unintended
data corruption
• Delete all records function
disallowed
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
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.
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
Enable Randomization Feature in
Project Settings
Set up Randomization on Project Setup
Screen
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
Treatment Randomization Module
Select and Save Criteria
Download Allocation Table Template
Example allocations !!
You will need to assign
your treatment allocations
based on your project’s
statistical analysis plan
Upload Allocation Tables
Duplicate allocations !!
You may not use the exact
same allocation table for
Production status that you
used in Development
status
Randomize Participant
Randomization Dashboard
Getting Started
• Enable Randomization
– 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
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User Rights
REDCap Lifelines
• Built-in tutorial videos
• Built-in Frequently Asked Question (FAQ)
guide
• Demonstration Databases (Some Online, more
to come)
• WUSM Biostat REDCap Email Help Queue
– [redcap@rt.biostat.wustl.edu]
– Monitored by 4 to 5 Administrators
REDCap Email Support
redcap@rt.biostat.wustl.edu
REDCap Goals
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Easy to use
Metadata Driven
Adaptable Features
Data entry validation
Self service tool
Questions?