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REDCap Overview

REDCap Overview . Marianne Chilutti April 1, 2011. Outline. REDCap Implementation REDCap Features & Demo Support. What is REDCap? ( R esearch E lectronic D ata Cap ture).

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REDCap Overview

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  1. REDCap Overview Marianne Chilutti April 1, 2011

  2. Outline REDCap Implementation REDCap Features & Demo Support

  3. 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

  4. 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)

  5. Approved Uses of REDCap • Not for clinical data used as primary records

  6. Total Number of Projects in REDCap Note: Test databases are not included

  7. Total Number of Users in REDCap

  8. 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

  9. Can control access for each data entry form Remove access to identifiers

  10. 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

  11. Filters Audit Trail Logging

  12. Outline REDCap Implementation REDCap Features & Demo Support

  13. Design Features New • Types of projects 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

  14. New Checklist

  15. Design Features • Stream-lined process for rapidly building a project • Point/Click & drag for real-time CRF Creation • Upload from Excel file • Copy from an existing project • Database changes easily implemented • Project field(s) can be modified or added while the study is in progress • Link together multiple REDCap Projects • 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 • 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)

  16. Coded Data Data entry forms (labels only) Variable definition Raw Data Export New Labels Data Export

  17. Data AcquisitionFeatures • 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

  18. 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) • Via e-mail upon participant completion • Import data from an Excel file • File template created automatically according to the project structure New

  19. 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 • 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) New

  20. Data Review: Graphical Data View & Stats Descriptive Stats View Click and open data entry page Soon to be available at CHOP…

  21. 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

  22. Project Phases • Development • Create, edit instruments (data entry forms/survey pages) • Assign user rights • Define events / arms • Test • Production • Collect data • Any changes after moving to Production require approval • Inactive • Data collection stopped • Can be returned to Production • Archived • Removed from list of projects • Can be returned to Production

  23. Demo

  24. 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

  25. Outline REDCap Implementation REDCap Features & Demo Support

  26. REDCap Consortium • Comprised of 213 active institutional partners • More than 9380 studies with over 18,590 end-users • Provides support to REDCap tool • CHOP is a partner of the Consortium • Meets weekly

  27. Institutional Support • No IS Help Desk support • One-on-one consultation • User Group monthly meetings • Provide information on REDCap (new patches / versions) • Discuss potential enhancement requests / issues • Provide forum for sharing user experience New

  28. 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)

  29. 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.

  30. 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

  31. Conclusion • REDCap • 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

  32. Questions?

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