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Policy No.: 8019

Effective Date: 08/14/23 Draft

Revised Date:

Reviewed Date:

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.

Responsibilities

• 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.

Policy

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.

• UNMC is beholden to the scope and general provisions outlined in the PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES regulations as defined in the FDA’s guidelines and interpretation of scope and application.
  • Authority: 21 U.S.C. 321–393; 42 U.S.C. 262.
  • Source: 62 FR 13464, Mar. 20, 1997, unless otherwise noted.

Additional Information

• DevOps Business Relationship Leads, UNMC.]
• Standard Operating Procedures FDA Part 11 Checklist
• Part 11, Electronic Records; Electronic Signatures - Scope and Application
• IRB Guidance for Investigators and Research Coordinators/Research Nurses
• Safeguarding Research Data

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