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REDCap FDA 21 CFR Part 11 Compliance for Validated Projects (Table of Contents)
Introduction
Welcome to the University of Utah CTSI REDCap FDA 21 CFR Part 11 Compliance training.
This course is designed to introduce the functionalities in REDCap that must be utilized to meet FDA part 11 compliance for research studies. By the end of this course, you should have a foundational understanding of what the part 11 compliance requirements are and how to meet those requirements in REDCap.
Study teams intending to use the CTSI REDCap validated instance for an FDA regulated study will be charged a flat fee which covers the CTSI BMIC staff project review and secure external file storage. Project builds with additional CTSI BMIC support will follow the published service recharge center rates.
In order to begin building a part 11 compliant project, the eConsent REDCap Template must be used.
When building the project, please note the instructional fields - these are included to guide you through developing your project to meet your specific needs. When you are finished building your project, delete these fields before requesting to move your project to production.
Once a request to move the project to production has been submitted, the project will be reviewed by CTSI BMIC staff to ensure all instruments and settings are in place to comply with FDA 21 CFR Part 11 regulations in REDCap.
Click on the links below to get started.
Table of Contents