Part 11 Compliance

If you are investigating a drug or device and are utilizing an electronic system to maintain your study records and/or use electronic signatures, your system must be compliant with Part 11 requirements.

Part 11 requirements

Boston University’s (BU’s) instance of REDCap is now available to use for FDA-regulated drug or device studies. If you are conducting a drug or device study and plan to use BU REDCap for any data collection, including e-consent, you must comply with FDA 21 CFR Part 11 requirements for electronic records and signatures. Please see guidance on this process here:

REDCap (Research Electronic Data Capture) Part 11 Process & Training

To get started, complete the BU REDCap Part 11 Request Form. For information regarding BU REDCap user access and support, please email REDCap support at rchelp@bu.edu.