Electronic Signatures

The UTHSC IRB's electronically signed documents are generated in compliance with the requirements of FDA regulation 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.

Whose Electronic Signatures Are Required?

Before you submit an application or response to the IRB, you must route the submission to the appropriate persons for their electronic signatures. See the table below for the required signatures.

If additional signatures are required, you will click YES to select additional personnel for routing in the iMedRIS Routing Form. Check off the name(s) of the appropriate individuals who will apply their electronic signatures. The system will send an email notification to all the individuals you selected. All required signatories will be directed to log into iMedRIS, review the submission, and apply their electronic signatures using their UT NetID and password.

Type of Submission	Required Signature(s)
UTHSC IRB Form 1: Study/Project Application	Principal Investigator(s) (PI); all Co/Sub-Investigators; Department Chair if PI is a UT student/fellow/resident/employee/faculty member; Faculty Advisor if PI is a student, fellow, or resident; and Hospital Service Chief (for Regional One Health studies)
Form 2: Change Request and Amendments	PI or Co/Sub-investigator; and any newly added investigator
Response to recommendations/provisos for any submission form Form 3: Continuing Review Form 4: Unanticipated Problems (Reportable Adverse Events/Deviations/Waivers) Form 6: Advertising/Recruitment Materials Data Safety Monitoring Board/Annual Reports Pre-Audit Submission Form Submit Miscellaneous Documents Form 7: Study Closure	PI or Co/Sub-investigator