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REDCap eConsent Template and 21 CFR Part 11 Compliance

The Clinical and Translational Sciences Institute (CTSI) is excited to announce the new “e-consent template” now available in the CTSI REDCap project template library. This project was a collaborative effort with the Utah Data Coordinating Center, the Institutional Review Board, and the Clinical and Translational Science Institute.

With the recent 21 CFR Part 11 validation of the CTSI’s instance of REDCap, this “e-consent template” can be used for studies where electronic consent is desired or required at no charge. However, FDA regulated studies require additional administrative oversight and recharge services to meet the requirements for 21 CFR Part 11 compliance.

Please visit the eConsent information page to access training, guidance and instructions to request a new project or to request CTSI Biomedical Informatics Core (BMIC) services to help set up your project to use this new template for eConsent.

Throughout Fall 2023,  the CTSI BMIC will be hosting presentations on how to use the template and tailoring it to meet your study needs. A list of scheduled presentations and information sessions is available at the CTSI REDCap home page. Please contact the CTSI BMIC service desk for assistance or additional information to help you get started.

Beginning November 3rd, the first Friday of every month will be dedicated to an eConsent Presentation starting at 8 am. 

Login to the CTSI REDCap instance to access the zoom links for each of the above sessions.