Marianne Chilutti April 1, 2011 REDCap Overview Marianne Chilutti April 1, 2011

Outline REDCap Implementation REDCap Features & Demo Support

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

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)

Approved Uses of REDCap Research QI / Outcomes Registries Operational Support Primary use of REDCap is for Research Not for clinical data used as primary records

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

Total Number of Users in REDCap

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

Remove access to identifiers 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

Filters Audit Trail Logging

Outline REDCap Implementation REDCap Features & Demo Support

Design Features Types of projects Purpose of projects 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

New Checklist

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)

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

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

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

Data Review Data Comparison tool Report Builder Data Export in Excel 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

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

Project Phases Development Production Inactive Archived 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

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

Outline REDCap Implementation REDCap Features & Demo Support

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

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

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)

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.

Upcoming features REDCap 4.1 (May, 2011) Beyond 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

Conclusion REDCap REDCap links 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

Questions?