Lynn Simpson Partners Research Computing, ERIS EDC Support Specialist, CCDM TOPICS: REDCap and REDCap Survey Overvie

1. Lynn Simpson • Partners Research Computing, ERIS • EDC Support Specialist, CCDM • TOPICS: • REDCap and REDCap Survey Overview • Security • How to Start a Project

2. 2004: Initially developed and deployed at Vanderbilt U. Medical Center by Paul Harris • 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: Beth Israel Deaconess Medical Center Cornell University Children's Hospital Boston Duke UniversityThe Cleveland ClinicCase Western Reserve University Kent State University Columbia University University of Cincinnati/Cincinnati Children's Hospital Northwestern University Mayo Clinic Medical University of South Carolina Oregon Health & Science University Partners HealthCare (2009)Singapore Clinical Research Institute Stanford Univ. School of Medicine Stony Brook University The Methodist Hospital Research Institute University of Colorado-DenverUniversity of New Mexico The University of Kansas Medical Center University of Pennsylvania University of Minnesota University of Massachusetts Medical School UW Seattle Vanderbilt University Yale University Institutions in bold have 20 or more projects in production • 900+ databases in production 600+ in development • 600+ surveys in production 1300+ in development Partners: • 4 projects in production MGH (2) Biostats Center, (2) Psychiatry • 15+ in development MGH: Dermatology, Medicine, MGPO BWH: Neurology, Endocrine, Psychiatry, Renal, Radiology

3. 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 • Simplified methodology for building projects • Basic question types, validation, calculations, branching logic • Additional Features • Multi-Site projects, double data entry, data management (lock forms) • No Analytical Tools - Robust data capture • Automated export procedures for data downloads: Excel, SPSS, SAS, Stata, R • Basic reporting tools What is REDCap?

4. REDCap System Configs • For end-users, most Web-browsers are compatible: Internet Explorer 6-8; Firefox 2-3,5; Safari; Chrome; Opera • 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

5. Is REDCap Secure? • Partners Hosted: Discovery Informatics Platform for Research Discovery (DIPR) Datacenter in Needham, MA. • All DIPR databases are backed up nightly, file-level backups by TSM. • Every 45 days data is backed up to Iron Mountain • Data is stored indefinitely • HTTPS and Secure Sockets Layer (SSL) enabled = secure connection to web server. • REDCap System security updates and alerts are reviewed and deployed by REDCap System Administrators to mitigate any harmful effects. • User access can be customized: databases, case report forms, surveys, and survey pages can be granted and restricted. • HIPAA Compliant • 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

6. 21 CFR Part 11 • Future release (Summer 2010): Consortium team working on a 21 CFR Part 11 Compliant Module • Updates to software: • Electronic Signatures • Enhanced Audit Trail • Validation Testing • 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.

7. How to Get Started: • Available NOW for any Partners investigators, researchers, departments… • Review website video tutorials and training resources: • https://redcapdev.partners.org/redcap_survey/1.3.5/index.php • https://redcapdev.partners.org/redcap/ • Contact Lynn Simpson: lasimpson@partners.org, 617.643.7711 • Future plans: scheduled monthly/weekly demonstrations and trainings • Build a REDCap Project:

8. Contacts Lynn Simpson lasimpson@partners.org 617.643.7711 Resources Vanderbilt REDCap project site:www.project-redcap.org Partners REDCap site: https://redcapdev.partners.org/redcap/index.phpPartners REDCap Survey site: https://redcapdev.partners.org/redcap_survey/1.3.5/index.php ERIS REDCap Wiki Research Computing Website: http://rc.partners.org