Electronic Digital Signatures and Records

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Policy No.: 8019
Effective Date: 08/14/23
Revised Date: 09/13/23
Reviewed Date: 07/09/24

Electronic, Digital Signatures and Records - FDA Regulated Research

Basis for Policy

Participation in FDA regulated protocols require the University Nebraska Medical Center (UNMC) to comply with the federal government’s rules, regulations and guidelines applicable to FDA regulated research. FDA Guidelines contained in Part 11, Electronic Records; Electronic Signatures - Scope and Application | FDA pertaining to FDA regulated research must be followed.


  • When UNMC manages FDA regulated protocols, UNMC is required to ensure electronic storage and management of information is consistent and in the same reliability as paper.
  • Documentation of system procedures must be maintained to ensure the integrity of the data.
  • Electronic Signatures must be facilitated and managed in a similar methodology as a wet signature on paper.


It is the policy of the University of Nebraska Medical Center (UNMC) to comply with the FDA’s regulations for the storage and management of Electronic Records and Electronic or Digital Signatures. These regulations include the Office of Management and Budget’s (OMB) Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards or Uniform Guidance 2 CFR Part 200. UNMC will also comply with regulations issued by sponsoring agencies as they relate to grants and contracts.

Additional Information

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