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REDCap Overview Marianne Chilutti April 1, 2011 1.

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Presentation on theme: "REDCap Overview Marianne Chilutti April 1, 2011 1."— Presentation transcript:

1 REDCap Overview Marianne Chilutti April 1,

2 Outline REDCap Implementation REDCap Features & Demo Support 2

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 3

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) 4

5 Approved Uses of REDCap 5 Not for clinical data used as primary records Research QI / Outcomes Registries Operational Support

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

7 Total Number of Users in REDCap 7

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 8

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 10

11 Audit Trail Filters

12 Outline REDCap Implementation REDCap Features & Demo Support 12

13 Design Features 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 13 New

14 Checklist New

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) 15

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

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 17

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 18 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) 19 New

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

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 21

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 22

23 Demo

24 Impact of Version 4 on existing projects All existing projects (databases + surveys) will be migrated into one single instance on April 8 th 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

25 Outline REDCap Implementation REDCap Features & Demo Support 25

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 26

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 27 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) 28

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. 29

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 30

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

32 Questions?

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