FDA-compliant version of SignNow Available

October 29, 2021

The university’s E-signature Service, SignNow, has a new version that is compliant with FDA regulations at 21 CFR Part 11. If you are someone who uses SignNow to obtain signatures for FDA-regulated documents, please fill out this form by November 29, 2021, and ITS will switch you over to the FDA-compliant version. You will receive a confirmation email once ITS has switched your account. After November 29, 2021, if you need your account to be the FDA‑compliant version, you should contact the ITS E-Signature team.

FDA-regulated studies still enrolling participants and using SignNow to document consent or assent electronically should transition to the FDA-compliant version of SignNow at the earliest opportunity but not later than December 20, 2021. Studies that are not FDA-regulated may use the standard version of SignNow to document consent or assent electronically. 

More information is available here on the IRBMED website, including relevant FAQs.