1. REDCap Introduction Your gateway to compliant data management. Presented by: Terri Shkuda Research Informatics Information Technology Department

2. What is REDCap? REDCap is a secure web-based application that supports data capture and management for research studies. Users will be able to quickly and intuitively build and manage research data forms and surveys. It is an electronic Case Report Form (eCRF) that is compliant with Penn State Hershey policies. 9/24/132

3. The REDCap Story… REDCap was initially developed at Vanderbilt University, through a CTSA grant and now has collaborative support from a wide consortium of over 700 domestic and international partners who actively serve to contribute, prioritize, test and support the application. REDCap has been made available at no charge to institutional partners. 9/24/133

4. Features Create forms for data entry and surveys Enter data with workflow for managing the project Surveys delivered to participants electronically Reuse of forms for multiple events/arms Data export to common statistical packages with de-identification tools Data import from Excel Record locking and e-signatures Real time quality rule checks and post collection data query resolution Double Data Entry for data quality improvement Access for multi-site studies Full audit trail 9/24/134

5. Form Development 9/24/135

6. Field Types and Validation 9/24/136 Determine validation Define Field Type

7. Data Entry 9/24/137

8. Exports to most common statistical packages De-identification Options o Automatic removal of pre-specified identifiers o Date Shifting o Automatic removal of text and note fields Develop quick reports for quality control Reporting & Exporting Data 9/24/138

9. Security & Integrity Audit logs Role-based user rights Annual Risk Analyses Developed Standard Operating Procedures for: ◦ Training ◦ Access ◦ Risk Management ◦ Test Plans Regularly scheduled network security scans Data stored in the Data Center and backed up nightly Currently working on a system validation to ensure that REDCap is 21 CFR Part 11 capable for those studies that wish to be compliant. 9/24/139

10. REDCap Advisory Group The REDCap Advisory Group is an multidisciplinary team who meets monthly to decide on acceptable uses, processes, delivery, data safety and security issues. Members: Phil Canakis – Research Informatics Liz Galgocy – Research QA John Graybeal – Neuroscience Institute Rebecca Jenkins - CTSI Terry Novchich – non-cancer CTO office Bill Pogash – Research QA Rosanne Pogash – PHS Data Management Jim Robertson – Research Informatics Terri Shkuda – Research Informatics with support from Matt Solovey for initial marketing. 9/24/1310

11. Collaboration & Support REDCap Consortium (>700 institutions) 9/24/1311 Researcher

12. Training Training is required for access to REDCap and to be compliant with 21 CFR Part 11. REDCap Introductory Session ◦ Offered biweekly at HMC and monthly at UP (video conferencing is available) ◦ Required for at least one project member Vanderbilt tutorials ◦ Available free on web (www.project-redcap.org)www.project-redcap.org ◦ Excellent step-by-step instructions through all modules Peer Training 9/24/1312

13. More information Visit our website at ctsi.psu.edu and click on REDCap.ctsi.psu.edu Vanderbilt University’s website for REDCap www.project-redcap.orgwww.project-redcap.org For further information, contact: REDCap@hmc.psu.edu. REDCap@hmc.psu.edu 9/24/1313 Questions…