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AMIA Now 2010: P. Harris, Vanderbilt University, C. McGraw, University of Cincinnati, M. Lin, Mayo Clinic
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Research Electronic Data Capture (REDCap)
Paul Harris Director, CTSA Biomedical Informatics Operations
Vanderbilt University
Cathy McGraw Manager, Clinical & Translational Research Informatics Center
University of Cincinnati
Michael Lin Informatics Core Manager
Mayo Clinic
REDCap – Consortium Model
Project History
Software Overview and Hands-On Demonstration
Post-Break Cleanup (Other Features + Future Plans)
REDCap at the University of Cincinnati - Cathy McGraw
REDCap at the Mayo Clinic – Michael Lin
REDCap Consortium Model
7,130 End-Users 2,180 Projects 115 Institutional Partners (Full)
Software + Support @ No Cost; Partners Host Their Own Data
REDCap Consortium Model
REDCap Consortium Model
www.project-redcap.org
REDCap – Consortium Model
Project History
Software Overview and Hands-On Demonstration
Post-Break Cleanup (Other Features + Future Plans)
REDCap at the University of Cincinnati - Cathy McGraw
REDCap at the Mayo Clinic – Michael Lin
REDCap Project History
2004 Needs Assessment Researchers needed help managing data for small/medium sized non-trial research projects (pilot, R01, PPG)
Hypothesis Researchers will do the right thing (secure, audit trails, etc) if provided an easy way to get needed tools
Problem Many projects, few resources
REDCap Project History
Solution: Metadata-driven application (no per-project programming)
2004 - First REDCap project operational at VU
2006 - REDCap Consortium Launched REDCap Consortium to share with other universities and foster collaboration for future development
2008 – CTSA Informatics Pilot Project (IPP) Award Increase capacity and streamline processes for collecting and managing data in diverse scientific areas of study
Vanderbilt Support Model
• Using CTSA funding, Vanderbilt offers REDCap and REDCap Survey tool at no charge to investigators.
1. Protects the Institution (centralized data capture, security) 2. Protects the researcher (data quality and continuity) 3. Protects the research participant (data security) 4. Cost effective - Informatics investment is minimal
• We also run a fee-for-service core that is available to research teams when REDCap will simply not fit (Multi-Tier Model - Tier 1 is REDCap and used by 99% of projects)
• Grant deadlines are the best time to make new friends … (let’s create a REDCap database shell so you’ll have a screenshot to go along with this boilerplate language)
• Researchers create their own data dictionaries REDCap 101 Training (weekly); + Video (on demand) REDCap 201 Training (bi-weekly) – Informatics + Biostatistics
REDCap – Consortium Model
Project History
Software Overview and Hands-On Demonstration
Post-Break Cleanup (Other Features + Future Plans)
REDCap at the University of Cincinnati - Cathy McGraw
REDCap at the Mayo Clinic – Michael Lin
1. Business Card: Username + Password
2. Type URL in any browser: http://tinyurl.com/24vdo7n
3. Follow along + later create as many projects as you wish for duration of the meeting. We will reset all accounts and destroy projects + data at end of the conference.
4. Please see me at meeting if you have questions or wish to discuss REDCap.
REDCap Tour – Main Page
Users See All Projects Where They Have Edit/View Rights
Dynamic Project Status
REDCap Application (Classic Model)
CRFs – Customized For Each Study
REDCap Core Modules– Available For All Studies
Project-Level Metadata Defined by Research Team
Case Report Forms Visual Status Data Validation
Numerous Field Types
+ Text (Free) (Number) (Phone) (Zip) (Date) +TextArea +Select +Radio +File
Branching Logic Auto-Variable Coding
Human Readable Labels
PDFs
Study Calendar – Participant Scheduling
Participant Scheduling Module Optional Visit-Level View Shows Status + CRFs (Longitudinal Model)
Data Export + De-ID Tools
Exports Raw Data + Stats Script Files (Labels, Coding
Embedded De-Identification Tools
Data Import Tools
Use Cases: Convert DB to REDCap Batch Data Uploads
Data Comparison Tools
Use Case: Double-Data Entry Studies
Audit Trails / Data Logging
Full Audit Logs – Data Changes and Page Views
Project File Repository
Project-Specific Files Uploaded Here
Project-Specific Files Downloaded Here
Data Export Files Auto-Saved
Rights Administration
Case Report Form Access REDCap Module Access
REDCap Project Owners Autonomously Control Access To Their Applications
Data Visualization / Cleaning
Automatically Graphs Categorical & Continuous Variables Primary Use Case: Data Cleaning -- Requires R-Apache Server Connection
Custom Reports
End-User Creation/Use of Custom Reports
Web-Based Project Creation
Point/Click Drag (Ajax) For Real-time CRF Creation
Optional Participant Scheduling Setup Screens
Longitudinal CRF Mapping
File-Based Project Creation
Consortium-Based CRF Creation
Public Consortium Site
Search Curated Instruments
Annotated Records
View as Web Page or PDF
If coming from REDCap, May import to your study
Released April, 2010
Consortium-Based CRF Creation
Send-It File Transfer Capacity
Secure Transfer Functions Also Exist Within Individual Project Modules (e.g. Data Export)
Files May Be Shared By Anyone With REDCap Access (No Project Required)
Secure Transfer of Files To Anyone With An E-Mail Address + Internet
REDCap Setup Tools (Instantiate New Project ~ 30 sec)
REDCap – Consortium Model
Project History
Software Overview and Hands-On Demonstration
Post-Break Cleanup (Other Features + Future Plans)
REDCap at the University of Cincinnati - Cathy McGraw
REDCap at the Mayo Clinic – Michael Lin
Top-Down and In-Line Video Training Resources
REDCap Survey - Direct Participant Data Capture
Currently @ 19 Institutions 172,000 Surveys Collected
Multi-Center Study Setup
Data stored centrally, but access is sequestered by site
21CFR Part 11 --- Ready
Release May, 2010
Next – Looking @ FISMA
Next - External Systems Interoperability
API: Currently Beta-Testing
DTS: Alpha-Testing – OHSU, VU + …
External Systems
Next – Multi-Language Rendering (need translators)
Works Now In RC-Survey
Next – Merging REDCap + REDCap-Survey
Works Now In RC-Survey
REDCap – Consortium Model
Project History
Software Overview and Hands-On Demonstration
Post-Break Cleanup (Other Features + Future Plans)
REDCap at the University of Cincinnati - Cathy McGraw
REDCap at the Mayo Clinic – Michael Lin
REDCap – Consortium Model
Project History
Software Overview and Hands-On Demonstration
Post-Break Cleanup (Other Features + Future Plans)
REDCap at the University of Cincinnati - Cathy McGraw
REDCap at the Mayo Clinic – Michael Lin
REDCap University of Cincinnati
Academic Health Center
Cathy McGraw Manager, Clinical & Translational Research Informatics Center
AMIA Now! Phoenix, AZ May 25, 2010
Results: Why do you care how Cincinnati manages REDCap?
My Model FTE
• Two Application Specialists at 0.5 FTE each alternate AM/PM each day monitoring “help-redcap” issue tracker
• Senior REDCap Administrator represents UC in Consortium and manages the REDCap installation (0.25 FTE).
• Team has two 1 hr meetings per week to review projects, issues, training needed.
My Model Training
• REDCap Administrator (SuperUser) – Approximately 10 hr for new person – Consortium resources- webinars, listserv, wiki, meetings
• User – 1 hr Initial Training required for project lead (primary contact),
optional for all team members – Additional training for special features as needed, typical < 3 hr
per project lifetime (variable); resources online
• Divisional Administrator – Data Managers or Project managers are provided training to
empower them in REDCap environment
My Model Support for Investigators
• Single entry support request at Research Central web site includes REDCap and data management consultation. Training provided for each project.
• Issue tracker (help-redcap) monitored 9-5 M-F by REDCap Administrators
• Appointments during 8 hours/week office hours; GoToMeeting off-site support
Setting Up a Functioning Data Management Service:
Getting Started
• CCHMC Biomedical Informatics provides web & database servers, server administrator, issue tracker
• Software is open source • Research Central website tracks support • CTSA funds 1 FTE User Support
Setting Up a Functioning Data Management Service:
Researcher Awareness
• REDCap started “under the radar” for the institution and established trust and a user base on its merits.
• Biomedical Informatics refers studies to REDCap as first-tier support, conserves their resources.
• We have complementary services, established trust and cooperation with staff and directors through CCTST.
Setting Up a Functioning Data Management Service: Institutional Acceptance
(Value Proposition)
Setting Up a Functioning Data Management Service:
Training (Evolution) • Study-specific personal training to start • Ad hoc training during project life-cycle • General training for new features • * user groups; user listserv are under
consideration • * need model for maximum efficiency for a
small staff in multi-institution, multi-campus environment
Lessons Learned • Tier system works. REDCap can be
positioned as first level product with more costly applications available when needs justify the cost.
• Data managers need a reason to support REDCap: demonstrate added value. REDCap is an asset they can share not a threat when they are empowered and included.
Lessons Learned 2 • Federated authentication is a great help
for multi-institutional sites. This may be beyond the scope of your service.
• Experienced database designers often have a hard time accepting EAV data model. You have to demonstrate that the functionality is acceptable.
Perspectives Consortium
• Widespread acceptance of REDCap encourages trust for the investigators
• Collaboration can be a byproduct of common tools
• REDCap Consortium members are a great resource. Vanderbilt staff provide resources that are very helpful.
REDCap
Michael Lin
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Where we are today Institution endorsed EDC solution
• 3 Tier model, augmented by Medidata Rave, SAS DMS • Granted dedicated server for external use
Approved use for non-research (clinical, HR, …) • Non-research contributes 0.5 FTE for support
Statistics: • 8000+ active protocols, 3000+ new submissions annually • REDCap CRF: 80 in production, 89 in development • REDCap Survey: 240 in production, 379 in development • Expecting continuous growth
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Comments from researchers:
• … REDCap saved me more than $10K last year…
• … we’ve been waiting for 10 years for something like this…
• … this is great, it allows me to manage my own study …
• … I get better data quality with the built-in validation capabilities…
Jun. 09: Endorsed as one of three EDC solutions Oct. 09: Training class started Nov. 09: Featured on new Mayo CTSA web site Feb. 10: Grand Round
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Training Model Biweekly training class
• 12:00pm @ Wednesday, one hour class • Moving toward advanced topics
Presentation to groups • By request
Self-learning • Videos and documents from the consortium
Sandbox projects
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Support Model Offered by CTSA Service Center
• Free tool, regulated access, self-service self-management • 1 FTE total support (0.5 FTE from non-research)
Team up with biostatisticians • Encourage early biostatistics consultation for better science • Leverage existing relationship
Team up with Health Science Research • Offers custom developed SAS DMS solutions • Compliment vs. competing
Team up with Survey Research Center • Better quality survey • Oversight of survey questions and wording
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Getting Started Define value proposition Define business model Manage and Resolve Resistance
• Listen to the oppositions • Build your allies
Aim big, start small • Piloting – identify gaps, smooth wrinkles • Set and manage expectation • Under promise, over deliver • Build and advertise success stories
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Value Proposition For Users
• Cost • Self managed, no bottle neck • Rapid deployment
For Biostatistics • “Clean” data • Incentive for consultation • Simple export to statistical packages
For Research Leaders • Cost • Regulatory/Compliance • Reduced liability/risk
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Communication Define target audience
• Leadership • Service providers (biostatisticians, study
coordinators, etc.) • Researchers
Communication mechanisms • Research newsletter • Study coordinator website • Education forums • Grand Rounds …
Word of mouth • Happy customers are strong allies…
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Lessons Learned Make it simple Customer satisfaction is key Maintain realistic expectations Different people have different priorities
(research leaders vs. researchers vs. IT) Tailor your message to the audience One-size-fits-all vs. tiered solutions
Questions & Comments Thank you!