Electronic Signatures

UTHSC IRB electronically signed documents comply with FDA regulation 21 CFR 11, which governs electronic records and signatures. This regulation establishes standards for making electronic records and signatures legally equivalent to their paper counterparts. Users of electronic signatures must certify to the FDA that their electronic signature carries the same legal weight as a handwritten one.

WHOSE SIGNATURES ARE REQUIRED?

When you submit a new application or change in investigator to the IRB, you must include the Investigator Responsibilities & Signatures document​.

Type of Submission	Required Signature/s
Study SmartForm – Single or Multi-Site and External	Principal Investigator/s (PI) All co/sub-investigator/s Faculty advisor if PI is student, resident, or fellow
Modification and Continuing Review SmartForm	Change in PI Any newly added investigator