Transcript REDCap (Research Electronic Database Capture)

Lynn Simpson
Partners Research Computing, ERIS
EDC Support Specialist, CCDM
TOPICS:
 REDCap and REDCap Survey Overview
 Security
 How to Start a Project
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2004: Initially developed and deployed at Vanderbilt U. Medical Center by Paul Harris
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2006: REDCap system was offered to other institutions and a consortium of domestic
and international users was formed.
2008: Harvard awarded CTSA – Harvard Catalyst
Today: REDCap Consortium is comprised of 89 active partners from CTSA, GCRC,
RCMI and other institutions:
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Beth Israel Deaconess Medical Center
Duke University
Kent State University
Northwestern University
Oregon Health & Science University
Stanford Univ. School of Medicine
University of Colorado-Denver
University of Pennsylvania
UW Seattle
Cornell University
The Cleveland Clinic
Columbia University
Mayo Clinic
Partners HealthCare (2009)
Stony Brook University
University of New Mexico
University of Minnesota
Vanderbilt University
Children's Hospital Boston
Case Western Reserve University
University of Cincinnati/Cincinnati Children's Hospital
Medical University of South Carolina
Singapore Clinical Research Institute
The Methodist Hospital Research Institute
The University of Kansas Medical Center
University of Massachusetts Medical School
Yale University
Institutions in bold have 20 or more projects in production
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900+ databases in production
600+ surveys in production
600+ in development
1300+ in development
Partners:
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4 projects in production
15+ in development
MGH (2) Biostats Center, (2) Psychiatry
MGH: Dermatology, Medicine, MGPO
BWH: Neurology, Endocrine, Psychiatry, Renal, Radiology
What is REDCap?
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Free, secure, web-based applications
1. Database: Traditional, Longitudinal,
Scheduling, Parent-Child Link
2. Web Survey Tool
Future release (Summer 2010): Combine for one
application
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Simplified methodology for building projects
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Basic question types, validation, calculations,
branching logic
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Additional Features
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Multi-Site projects, double data entry,
data management (lock forms)
No Analytical Tools - Robust data capture
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Automated export procedures for data
downloads: Excel, SPSS, SAS, Stata, R
Basic reporting tools
REDCap System Configs

For end-users, most Web-browsers are compatible: Internet Explorer 6-8; Firefox
2-3,5; Safari; Chrome; Opera
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On the server side, REDCap requires basic infrastructure and can run on various
operating systems, such as Windows, Linux, Unix, or Mac.

It requires 1) a web server with PHP (e.g. Apache or IIS) that has the PEAR package
installed; 2) a MySQL database server; and 3) an email server that is configured
with PHP on web server (used to send emails from the application).
Current Applications:
 REDCap 3.0.3
 REDCap Survey 1.3.5
Operating System:
 Red Hat Enterprise Linux 5.2
 Apache 2.2.11
 PHP 5.2.9
 MySQL 5.0.45
Application Configurations:
 Tabled-based authentication method (Future? move to LDAP and table-based)
 Auto logout after 30 minutes of inactivity
https://research.partners.org/wiki/index.php/REDCap_System_Configurations
Is REDCap Secure?

Partners Hosted: Discovery Informatics Platform for Research Discovery (DIPR)
Datacenter in Needham, MA.
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All DIPR databases are backed up nightly, file-level backups by TSM.
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Every 45 days data is backed up to Iron Mountain
Data is stored indefinitely
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HTTPS and Secure Sockets Layer (SSL) enabled = secure connection to web server.
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REDCap System security updates and alerts are reviewed and deployed by REDCap
System Administrators to mitigate any harmful effects.
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User access can be customized: databases, case report forms, surveys, and survey
pages can be granted and restricted.
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HIPAA Compliant
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Audit Trails
User Authentication
Study, Site, Role-based Security
De-identified Data Sets
No More Survey Monkey!!
https://research.partners.org/wiki/index.php/REDCap_Security
21 CFR Part 11
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Future release (Summer 2010): Consortium team working on a 21 CFR Part 11
Compliant Module
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Updates to software:
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Electronic Signatures
Enhanced Audit Trail
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Validation Testing
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Documentation:
Policy and Procedural Requirements
 Technical Controls for Closed Systems
 Signature Manifestations
 Electronic Signature Components and Control
 Controls for Identification of Codes / Passwords

Computer systems utilizing electronic records and signatures must ensure accuracy,
reliability, and consistent performance. Standard operating procedures (SOPs), audits,
testing and training are required.
How to Get Started:
Available NOW for any Partners investigators, researchers, departments…
 Review website video tutorials and training resources:
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Contact Lynn Simpson:
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https://redcapdev.partners.org/redcap_survey/1.3.5/index.php
https://redcapdev.partners.org/redcap/
[email protected], 617.643.7711
Future plans: scheduled monthly/weekly demonstrations and trainings
Build a REDCap Project:
Contacts
Lynn Simpson
[email protected]
617.643.7711
Resources
Vanderbilt REDCap project site: www.project-redcap.org
Partners REDCap site: https://redcapdev.partners.org/redcap/index.php
Partners REDCap Survey site: https://redcapdev.partners.org/redcap_survey/1.3.5/index.php
ERIS REDCap Wiki
Research Computing Website: http://rc.partners.org