REDCap101March2011

Report
REDCap Overview
Marianne Chilutti
April 1, 2011
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Outline
REDCap Implementation
REDCap Features & Demo
Support
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What is REDCap? (Research Electronic Data Capture)
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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
Research
QI / Outcomes
Registries
Operational
Support
Not for clinical
data used as
primary records
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Total Number of Projects in REDCap
300
273
250
200
174
Research
150
QI
134
Operational Support
100
77
50
23
33
0
2009-Q4
2010-Q1
2010-Q2
Note: Test databases are not included
2010-Q3
2010-Q4
2011-Q1
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Total Number of Users in REDCap
250
226
200
175
150
121
100
82
50
30
16
0
2009-Q4
2010-Q1
2010-Q2
2010-Q3
2010-Q4
2011-Q1
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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
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Can control access for each data
entry form
Remove access to
identifiers
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
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L
o
g
g
i
n
g
Audit Trail
Filters
Outline
REDCap Implementation
REDCap Features & Demo
Support
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Design Features
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Types of projects
New
1) Single Survey
2) Single Survey + Data Entry Forms
3) Data Entry Forms only
- longitudinal: multiple events and multiple arms
- classic: single event
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Purpose of projects
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–
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Research
QI
Operational Support
Test or Practice
Multiple languages
– English, Spanish and Japanese
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New
Checklist
•
Design Features
Stream-lined process for rapidly building a project
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•
Database changes easily implemented
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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
–
•
Project field(s) can be modified or added while the study is in progress
Link together multiple REDCap Projects
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Point/Click & drag for real-time CRF Creation
Upload from Excel file
Copy from an existing project
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)
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Coded Data
Data entry forms (labels only)
Variable definition
Raw Data Export
Labels Data Export
New
Data Acquisition Features
• Supports following advanced features for data entry
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–
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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)
New
– Via e-mail upon participant completion
• Import data from an Excel file
– File template created automatically according to the project structure
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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
New
– 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)
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Data Review: Graphical Data View & Stats
Descriptive Stats View
Click and open data entry page
Soon to be available at CHOP…
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
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Development
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Production
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Collect data
Any changes after moving to Production require approval
Inactive
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Create, edit instruments (data entry forms/survey pages)
Assign user rights
Define events / arms
Test
Data collection stopped
Can be returned to Production
Archived
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Removed from list of projects
Can be returned to Production
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Demo
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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Outline
REDCap 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 endusers
• 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
New
– Provide information on REDCap (new patches /
versions)
– Discuss potential enhancement requests / issues
– Provide forum for sharing user experience
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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
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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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• REDCap
Conclusion
– 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
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Questions?

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