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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
Software + Support @ No Cost; Partners Host Their Own Data

7,130 End-Users
2,180 Projects
115 Institutional Partners (Full)
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

Researchers create their own data dictionaries


REDCap 101 Training (weekly); + Video (on demand)
REDCap 201 Training (bi-weekly) Informatics + Biostatistics

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


(lets create a REDCap database shell so youll have a
screenshot to go along with this boilerplate language)
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

Dynamic Project Status

Users See All Projects Where They Have Edit/View Rights


REDCap Application (Classic Model)
CRFs Customized For Each Study

REDCap Core Modules Available For All Studies

Project-Level Metadata Defined by Research Team


PDFs
Case Report Forms
Visual Status Data Validation

Numerous
Field Types

+ Text
Human (Free)
Readable (Number)
Labels (Phone)
(Zip)
(Date)
+TextArea
+Select
+Radio
+File

Branching
Auto-Variable Coding Logic
Study Calendar Participant Scheduling

Participant Scheduling Module Optional


Visit-Level View Shows Status + CRFs (Longitudinal Model)
Data Export + De-ID Tools
Embedded
De-Identification
Tools

Exports Raw
Data + Stats
Script Files
(Labels, Coding
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

REDCap
Project Owners
Autonomously
Control Access
To Their
Applications

REDCap Module Access


Case Report Form Access
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

Longitudinal
CRF Mapping
Optional
Participant
Scheduling
Setup
Screens
File-Based Project Creation
Consortium-Based CRF Creation
Consortium-Based CRF Creation
Public Consortium Site

Search Curated
Instruments

Released April, 2010

Annotated Records

View as Web Page or PDF

If coming from REDCap,


May import to your study
Send-It File Transfer Capacity

Secure Transfer of
Files To Anyone
With An E-Mail
Address + Internet

Files May Be Shared


By Anyone With
REDCap Access
(No Project Required)

Secure Transfer
Functions Also
Exist Within Individual
Project Modules
(e.g. Data Export)
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
Setting Up a Functioning Data Management Service:

Institutional Acceptance
(Value Proposition)
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:
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
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

CPXXXXXX-2
Comments from researchers:
REDCap saved me more than $10K last
year

weve 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 CPXXXXXX-3
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

CPXXXXXX-5
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

CPXXXXXX-6
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
CPXXXXXX-7
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

CPXXXXXX-8
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

CPXXXXXX-9
Questions & Comments
Thank you!

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