Use of Electronic Signatures for Essential Documents in Clinical Research Policy

The policy establishes the requirements for using University-approved electronic research systems to obtain legally valid electronic signatures on essential documents for clinical research at the University of North Carolina at Chapel Hill (“University” or “UNC-Chapel Hill”). Its purpose is to ensure regulatory compliance, enhance efficiency, and improve oversight of electronic signatures in clinical research.

University Policy

Title

University of North Carolina at Chapel Hill Policy on Use of Electronic Signatures for Essential Documents in Clinical Research

Introduction

Purpose

The policy establishes the requirements for using University-approved electronic research systems to obtain legally valid electronic signatures on essential documents for clinical research at the University of North Carolina at Chapel Hill (“University” or “UNC-Chapel Hill”). Its purpose is to ensure regulatory compliance, enhance efficiency, and improve oversight of electronic signatures in clinical research.

Scope

This Policy is applicable to all University Units and Covered Individuals utilizing electronic signatures on essential documents in the conduct of clinical research.  

This Policy does not apply to electronic signatures on contractual or grant related documents.

Policy

Policy Statement

Electronic signatures must be legally valid within the governing jurisdictions where the research activity is conducted.

All electronic signatures on essential documents must be obtained using a University-approved electronic research system to ensure security, verifiability and compliance with federal and institutional standards.

For FDA-regulated clinical investigations, electronic signatures must be obtained using a University-approved, 21 CFR § 11 compliant system. The identity of the signing individual must be verified before obtaining the signature.

The Clinical Research Compliance Office will monitor adherence to this policy. Noncompliance may result in disciplinary action.

Definitions

Clinical Investigation: Any experiment that involves a test article and one or more human subjects, which must meet the requirements for prior submission to the FDA or whose results are intended for submission to, or inspection by, the FDA as part of an application for research or marketing permit.

Covered Individuals: Those engaged in research, including faculty, staff (SHRA and EHRA non-faculty), students, volunteers, interns, visiting scholars, collaborators, and consultants.   

Clinical Research: Research with human subjects (human subject) that is:

1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes: (a) mechanisms of human disease, (b), therapeutic interventions, (c) clinical trials (clinical trial), or (d) development of new technologies.
2. Epidemiological and behavioral studies.
3. Outcomes research and health services research.

Note: Studies falling under 45 CFR Part 46.101(b)(4) (the “Common Rule” prior to July 19, 2018) and 45 CFR 46.104(d)(4) (the “Revised Common Rule” effective July 19, 2018, Exemption 4) are not considered clinical research by this definition.

Electronic Signature: An electronic sound, symbol, or process, attached to or logically associated with a contract or other record and executed or adopted by a person with the intent to sign the record. See Uniform Electronic Transactions Act (N.C. Gen. Stat. § 66-311, et seq. The FDA defines it as “a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature” (21 CFR § 11.3).

Electronic Research System: A software platform designed to manage various aspects of the research process, providing a centralized approach to handling tasks related to planning, conducting, and monitoring research activities. For university-approved electronic research systems, refer to UNC Research: Research Administrative Systems

Essential Documents: Documents that individually and collectively permit evaluation of the conduct of a clinical research study and the quality of the data produced (E6(R2) Good Clinical Practice).

University Units: Any Department, Divisions, or Centers/Institutes of the University of North Carolina at Chapel Hill.  

21 CFR § 11: A set of FDA regulations defining the criteria under which electronic records and signatures are considered trustworthy, reliable, and equivalent to paper records.

Related Requirements

External Regulations 

• FDA: 21 CFR 11, Electronic Records; Electronic Signatures
• FDA: Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers, Guidance for Industry
• E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1), Guidance for Industry

University Policies, Standards, and Procedures 

• UNC Office of Human Research Ethics SOP 1301: FDA-Regulated Research
• UNC Research: eSignature and eConsent
• UNC Research: Research Administrative Systems

Contact Information

Primary Contact

Name: Valorie Buchholz, Senior Director

Unit: Clinical Research Compliance

Email: buchholz@unc.edu