REDCap

REDCap (Research Electronic Data Capture) is a secure web application developed by Vanderbilt for building and managing online surveys and databases for clinical research. Although REDCap was originally developed for clinical research, its use has expanded to include operation support and quality improvement purposes. REDCap can be used to collect virtually any type of data and provides a HIPAA-compliant environment. REDCap is also able to support UVA researchers by allowing them to serve as the Coordination Center for research studies. This ensures easy collaboration between research sites and data sharing.

Attention: The REDCap system is NOT 21 CFR Part 11 compliant. This means that it should NOT be used IF

• your study is FDA regulated AND the data will be submitted as part of a marketing approval application OR
• your study is FDA regulated AND the study involves eConsent

REDCap provides a user-friendly interface that allows users to quickly build case report forms with the ability to support features such as surveys, calendars for scheduling, longitudinal events, various levels of access for users, and more. Please see the attached document detailing the UVA REDCap Features & Capabilities for more information on the features available.

Your REDCap project data is kept secure and private. REDCap can remove identifiers from a dataset prior to exporting for analysis to create a limited dataset or a safe harbor data set. By removing the 18 pieces of information considered PHI, Protected Health Information, for the purposes of HIPAA compliance (HIPAA Patient Identifiers), you are generating a safe harbor data set; you can then share this data with collaborators more easily. Your redcap data storage and collection is guaranteed the following:

• Data stored on a secure HIPAA compliant server
• Database access requires user authentication with password
• Data access based on an individual’s role on a project
• Logging and audit trails on all data interactions
• UVA IRB and UVA Information Security (Information Policy Office) approved for collection and storage of PHI including surveys

Other resources for HIPAA: https://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html , HH – NIH HIPAA Privacy Rule