FWA Letter: This letter describes the regulatory requirements under which the UTHSC IRB operates.
Registration Letter: This letter includes information regarding the registration of the UTHSC IRB.
21 CFR 11: This document explains how iMedRIS addresses the requirements of FDA 21 CFR 11. This federal regulation pertains to electronic records/electronic signatures and sets forth criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. People using electronic signatures must certify to the agency that the electronic signature in their system is intended to be the legally binding equivalent of traditional handwritten signatures.
UTHSC IRB office
Memphis, TN 38163
Phone: (901) 448-4824
Fax: (901) 448-5103