REDCap Overview Marianne Chilutti April 1, 2011 1 Outline REDCap Implementation REDCap Features & Demo Support 2 What is REDCap? (Research Electronic Data Capture) • • Secure, web-based application designed to support electronic data capture for research studies Advantages of REDCap – Availability - Software is available at no cost – Secure and web-based - Input data or build a project from anywhere over a secure web connection with authentication and audit trail – Fast and flexible - Conception to production-level project in less than one day – Multi-site access - REDCap projects can be used by researchers from multiple sites – Autonomous utilization - Research groups have complete autonomy to control user access – Export data to common data analysis packages- SAS, Stata, R, and SPSS – Fully customizable - Research groups are in total control of shaping a project – Advanced features - Mid-study modifications, auto-validation, branching logic, and calculated fields 3 REDCap Background • REDCap was initially developed and deployed by CBMi counterparts at Vanderbilt University (Nashville) • REDCap was selected by CBMi to offer for Researchers – A user-friendly alternative: you can build databases yourself – A cost-effective alternative: free – A secure application to promote HIPAA compliance • Implemented at CHOP in June 2009 – Available to all CHOP employees – Use the same username/password you currently use to access the CHOP network • URL: http://redcap.research.chop.edu (available soon on Research Intranet) 4 Approved Uses of REDCap Research QI / Outcomes Registries Operational Support Not for clinical data used as primary records 5 Total Number of Projects in REDCap 300 273 250 200 174 Research 150 QI 134 Operational Support 100 77 50 23 33 0 2009-Q4 2010-Q1 2010-Q2 Note: Test databases are not included 2010-Q3 2010-Q4 2011-Q1 6 Total Number of Users in REDCap 250 226 200 175 150 121 100 82 50 30 16 0 2009-Q4 2010-Q1 2010-Q2 2010-Q3 2010-Q4 2011-Q1 7 REDCap Compliance • Access control is fully configurable – User accounts created from Active Directory at CHOP – Controlled access to identifiers • User may define which variables to use as identifiers • Limited access to identified data – Project owner authorizes study staff access, as required per IRB protocol – Controlled data modification • ‘Lock / Unlock data’ and ‘eSignatures’ features – Read-only access after study closure 8 Can control access for each data entry form Remove access to identifiers REDCap Compliance • Centralization of data on a local secure server – Data and application reside on CHOP servers – Twice-daily backups • Audit trail – Information on ‘who, when and reason for changes’ is tracked by the system and can be easily extracted 10 L o g g i n g Audit Trail Filters Outline REDCap Implementation REDCap Features & Demo Support 12 Design Features • Types of projects New 1) Single Survey 2) Single Survey + Data Entry Forms 3) Data Entry Forms only - longitudinal: multiple events and multiple arms - classic: single event • Purpose of projects – – – – • Research QI Operational Support Test or Practice Multiple languages – English, Spanish and Japanese 13 New Checklist • Design Features Stream-lined process for rapidly building a project – – – • Database changes easily implemented – • – When building multiple projects that have some fields in common, such as demographics One or more projects can be linked to a single shared parent project (e.g. a project with only demographic information). The parent's data entry pages will appear in the child's left-hand menu, and users will be able to access all the data from the 'parent' study seamlessly Easily manage a contact list of survey respondents or create a simple survey link – • Project field(s) can be modified or added while the study is in progress Link together multiple REDCap Projects – – • Point/Click & drag for real-time CRF Creation Upload from Excel file Copy from an existing project Build a participant list, create custom email invitations and track who responds, and/or create a single survey link to e-mail out or post on a website Print empty CRF pages (requested by IRB protocol) 15 Coded Data Data entry forms (labels only) Variable definition Raw Data Export Labels Data Export New Data Acquisition Features • Supports following advanced features for data entry – – – – Auto-validation (ranges / data checks / required) Branching/skip logic and survey stop actions Data calculation (e.g. can automatically calculate value for Body Mass Index) File-uploading and sending of files (links) from REDCap database with link expiring option • General project-related documents • Documents for individual project records, uploaded directly from data entry form – Double data entry available – Save data collection instruments as a PDF to print for offline data collection – Mobile interface on tablets and smart phones 17 Data Acquisition Features • Multi-site access - Researchers from multiple sites and institutions can access same project - Access can be restricted by site • Calendar / Scheduling – Utilize a built-in project calendar and scheduling module for organizing events and appointments • Triggers & Notifications (surveys only) New – Via e-mail upon participant completion • Import data from an Excel file – File template created automatically according to the project structure 18 Data Review • Data Comparison tool • Report Builder – To create, save and print data reports • Data Export in Excel • PDF: data for all records may be downloaded in a single PDF file New – Contains the actual page format as seen on the data entry page or survey – Includes all data for all records for all data collection instruments – If data need to be sent to IRB within a short time period (unexpected events for example) 19 Data Review: Graphical Data View & Stats Descriptive Stats View Click and open data entry page Soon to be available at CHOP… Data Analysis • Easy export to Microsoft Excel, SAS, Stata, R, or SPSS for analysis – One-click Export option – Ability to de-identify in one click option – Advanced Export option for more granular control over the data being exported – Generates syntax and data files – A back-up copy of all exported files is placed in the File Repository New 21 Project Phases • Development – – – – • Production – – • Collect data Any changes after moving to Production require approval Inactive – – • Create, edit instruments (data entry forms/survey pages) Assign user rights Define events / arms Test Data collection stopped Can be returned to Production Archived – – Removed from list of projects Can be returned to Production 22 Demo Impact of Version 4 on existing projects • All existing projects (databases + surveys) will be migrated into one single instance on April 8th • All new features apply to all projects – Modifications may be needed to use some new features • Data Dictionary (DD) is modified (new and deleted columns) – If changes are needed after migration and if changes are made using the DD , download first the DD and apply changes -- do not use a DD downloaded before migration • Data Export – When exporting to SAS or SPSS, "notes" fields are now set to a maximum of 5000 characters in the syntax files (was previously set to 500) • Existing active projects must be tested 24 Outline REDCap Implementation REDCap Features & Demo Support 25 REDCap Consortium • Comprised of 213 active institutional partners – More than 9380 studies with over 18,590 endusers • Provides support to REDCap tool • CHOP is a partner of the Consortium • Meets weekly 26 Institutional Support • No IS Help Desk support • One-on-one consultation • User Group monthly meetings New – Provide information on REDCap (new patches / versions) – Discuss potential enhancement requests / issues – Provide forum for sharing user experience 27 Need help…. • Video Tutorials and help text available within REDCap • You can build your project yourself but if you need help: • Core Data Management services available for any data management activities (pending grant availability) 28 Citing REDCap • When publishing manuscripts – Study data were collected and managed using REDCap electronic data capture tools hosted at CHOP/CBMI. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. 29 Upcoming features • REDCap 4.1 (May, 2011) – Asynchronous project ("REDCap Offline") – Expanded survey functionality (e.g. use multiple forms as surveys) • Beyond May, 2011 – – – – – Data transfer services to/from external data sources Dynamically repeating fields Handling missing data Implementing data queries/triggers for fields Randomization 30 • REDCap Conclusion – Free – Easy to use – Support tools available • REDCap links – REDCap: http://redcap.research.chop.edu – REDCap Test (version 4): https://tiu.research.chop.edu/redcap_test/redcap/ – REDCap Mobile (version 4): http://redcap.research.chop.edu/redcap_test/redcap/redcap_v4.0.1/Mobile/ #outer 31 Questions?