REDCap Treatment Randomization Module

By J Kevan Essmyer

Acknowledgements:Paul Harris (Vanderbilt CTSA)

Jack Baty (WUSM REDCap Admin)

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…

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

File Server

Host Server

WEB Server

Uploaded Files

Installation Files

WEB Server

WU Campus

Sidedoor Server

https://redcapsurvey.wustl.edu...

REDCap Survey

Data Entry /Admin

Data Entry /Admin

MySQL Server

MySQL Slave Server

Data

Sync

Biostatistics Secure Domain

Authenticated Access

Public HTTPS Survey Access

WUSM REDCap Servers(http://www.biostat.wustl.edu/redcap)

Development “Trying it Out”

• 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”

• REDCap Project Request form (Fax or email)– 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

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 TablesDuplicate 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

“?!!?”

User Rights

Branching

Logic

Scheduling

API

Data Dictionary

Data

Validation

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

• Easy to use• Metadata Driven • Adaptable Features• Data entry validation• Self service tool

Questions?