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REDCap Overview

Marianne ChiluttiApril 1, 2011

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OutlineREDCap Implementation

REDCap Features & Demo

Support

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What is REDCap? (Research Electronic Data Capture)• Secure, web-based application designed to support electronic data capture for research

studies• Advantages of REDCap

– Availability - Software is available at no cost – Secure and web-based - Input data or build a project from anywhere over a secure web

connection with authentication and audit trail– Fast and flexible - Conception to production-level project in less than one day– Multi-site access - REDCap projects can be used by researchers from multiple sites– Autonomous utilization - Research groups have complete autonomy to control user access– Export data to common data analysis packages- SAS, Stata, R, and SPSS– Fully customizable - Research groups are in total control of shaping a project– Advanced features - Mid-study modifications, auto-validation, branching logic, and calculated

fields

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REDCap Background• REDCap was initially developed and deployed by CBMi counterparts at

Vanderbilt University (Nashville)• REDCap was selected by CBMi to offer for Researchers

– A user-friendly alternative: you can build databases yourself– A cost-effective alternative: free– A secure application to promote HIPAA compliance

• Implemented at CHOP in June 2009– Available to all CHOP employees– Use the same username/password you currently use to access the CHOP network

• URL: http://redcap.research.chop.edu (available soon on Research Intranet)

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Approved Uses of REDCap

Not for clinical data used as

primary records

Primary use of REDCap is for Research

ResearchQI / Outcomes

Registries

Operational Support

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Total Number of Projects in REDCap

Note: Test databases are not included

2009-Q4 2010-Q1 2010-Q2 2010-Q3 2010-Q4 2011-Q10

50

100

150

200

250

300

2333

77

134

174

273

ResearchQIOperational Support

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Total Number of Users in REDCap

2009-Q4 2010-Q1 2010-Q2 2010-Q3 2010-Q4 2011-Q10

50

100

150

200

250

1630

82

121

175

226

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REDCap Compliance• Access control is fully configurable

– User accounts created from Active Directory at CHOP – Controlled access to identifiers

• User may define which variables to use as identifiers• Limited access to identified data

– Project owner authorizes study staff access, as required per IRB protocol– Controlled data modification

• ‘Lock / Unlock data’ and ‘eSignatures’ features

– Read-only access after study closure

Can control access for each data entry form

Remove access to identifiers

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REDCap Compliance• Centralization of data on a local secure server– Data and application reside on CHOP servers– Twice-daily backups

• Audit trail– Information on ‘who, when and reason for

changes’ is tracked by the system and can be easily extracted

Audit TrailFilters

Logging

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OutlineREDCap Implementation

REDCap Features & Demo

Support

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Design Features• Types of projects

1) Single Survey 2) Single Survey + Data Entry Forms3) Data Entry Forms only

- longitudinal: multiple events and multiple arms- classic: single event

• Purpose of projects– Research– QI– Operational Support– Test or Practice

• Multiple languages– English, Spanish and Japanese

New

Checklist

New

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Design Features• Stream-lined process for rapidly building a project

– Point/Click & drag for real-time CRF Creation – Upload from Excel file– Copy from an existing project

• Database changes easily implemented– Project field(s) can be modified or added while the study is in progress

• Link together multiple REDCap Projects– When building multiple projects that have some fields in common, such as demographics– One or more projects can be linked to a single shared parent project (e.g. a project with only demographic

information). – The parent's data entry pages will appear in the child's left-hand menu, and users will be able to access all the data

from the 'parent' study seamlessly • Easily manage a contact list of survey respondents or create a simple survey link

– Build a participant list, create custom email invitations and track who responds, and/or create a single survey link to e-mail out or post on a website

• Print empty CRF pages (requested by IRB protocol)

Coded Data Variable definition

Labels Data Export

Data entry forms (labels only)

Raw Data Export

New

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Data Acquisition Features• Supports following advanced features for data entry

– Auto-validation (ranges / data checks / required)– Branching/skip logic and survey stop actions– Data calculation (e.g. can automatically calculate value for Body Mass Index)– File-uploading and sending of files (links) from REDCap database with link

expiring option• General project-related documents• Documents for individual project records, uploaded directly from data entry form

– Double data entry available– Save data collection instruments as a PDF to print for offline data collection– Mobile interface on tablets and smart phones

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Data Acquisition Features• Multi-site access

- Researchers from multiple sites and institutions can access same project- Access can be restricted by site

• Calendar / Scheduling– Utilize a built-in project calendar and scheduling module for organizing

events and appointments• Triggers & Notifications (surveys only)

– Via e-mail upon participant completion• Import data from an Excel file

– File template created automatically according to the project structure

New

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Data Review• Data Comparison tool• Report Builder

– To create, save and print data reports• Data Export in Excel• PDF: data for all records may be downloaded in a single PDF file

– Contains the actual page format as seen on the data entry page or survey– Includes all data for all records for all data collection instruments– If data need to be sent to IRB within a short time period (unexpected

events for example)

New

Data Review: Graphical Data View & Stats

Soon to be available at CHOP…

Click and open data entry page

Descriptive Stats View

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Data Analysis• Easy export to Microsoft Excel, SAS, Stata, R, or SPSS for

analysis – One-click Export option– Ability to de-identify in one click option– Advanced Export option for more granular control over the data

being exported– Generates syntax and data files– A back-up copy of all exported files is placed in the File

Repository

New

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Project Phases

• Development– Create, edit instruments (data entry forms/survey pages)– Assign user rights– Define events / arms– Test

• Production– Collect data– Any changes after moving to Production require approval

• Inactive– Data collection stopped– Can be returned to Production

• Archived– Removed from list of projects– Can be returned to Production

Demo

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Impact of Version 4 on existing projects• All existing projects (databases + surveys) will be migrated into one single

instance on April 8th • All new features apply to all projects

– Modifications may be needed to use some new features• Data Dictionary (DD) is modified (new and deleted columns)

– If changes are needed after migration and if changes are made using the DD , download first the DD and apply changes -- do not use a DD downloaded before migration

• Data Export– When exporting to SAS or SPSS, "notes" fields are now set to a maximum of 5000

characters in the syntax files (was previously set to 500)• Existing active projects must be tested

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OutlineREDCap Implementation

REDCap Features & Demo

Support

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REDCap Consortium• Comprised of 213 active institutional partners– More than 9380 studies with over 18,590 end-

users• Provides support to REDCap tool• CHOP is a partner of the Consortium• Meets weekly

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Institutional Support• No IS Help Desk support• One-on-one consultation • User Group monthly meetings– Provide information on REDCap (new patches /

versions)– Discuss potential enhancement requests / issues– Provide forum for sharing user experience

New

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Need help….• Video Tutorials and help text available within

REDCap• You can build your project yourself but if you

need help:• Core Data Management services available for any data

management activities (pending grant availability)

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Citing REDCap• When publishing manuscripts

– Study data were collected and managed using REDCap electronic data capture tools hosted at CHOP/CBMI. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources.

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Upcoming features• REDCap 4.1 (May, 2011)

– Asynchronous project ("REDCap Offline") – Expanded survey functionality (e.g. use multiple forms as surveys)

• Beyond May, 2011– Data transfer services to/from external data sources – Dynamically repeating fields – Handling missing data – Implementing data queries/triggers for fields – Randomization

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Conclusion• REDCap

– Free– Easy to use– Support tools available

• REDCap links– REDCap: http://redcap.research.chop.edu– REDCap Test (version 4): https://tiu.research.chop.edu/redcap_test/redcap/ – REDCap Mobile (version 4):

http://redcap.research.chop.edu/redcap_test/redcap/redcap_v4.0.1/Mobile/#outer

Questions?