1. Marianne Chilutti April 1, 2011
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: (available soon on Research Intranet)

5. 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

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. Remove access to identifiers
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 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

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 invitations and track who responds, and/or create a single survey link to 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 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

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 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 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

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 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

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) 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

31. Conclusion REDCap REDCap links Free Easy to use
Support tools available
REDCap links
REDCap:
REDCap Test (version 4):
REDCap Mobile (version 4):

32. Questions?