s01: redcap-research electronic data capture

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!