Electronic Digital Signatures and Records: Difference between revisions

From University of Nebraska Medical Center
Jump to navigation Jump to search
mNo edit summary
mNo edit summary
Line 29: Line 29:
==Additional Information==
==Additional Information==


* [[Devopsbrl@unmc.edu|DevOpsBusiness Relationship Leads, UNMC.]]
* [[Mailto:Devopsbrl@unmc.edu|DevOpsBusiness Relationship Leads, UNMC.]]
* [https://univnebrmedcntr.sharepoint.com.mcas.ms/teams/FDAPart11Checklist/_layouts/15/AccessDenied.aspx?Source=https%3A%2F%2Funivnebrmedcntr%2Esharepoint%2Ecom%2Fteams%2FFDAPart11Checklist%2FShared%20Documents%2FForms%2FAllItems%2Easpx%3Fviewid%3D60e03d35%252D2539%252D439e%252Db1bb%252Dea61de066528&correlation=f5e3cca0%2Dc0ff%2D4000%2D0541%2De52ab4f3efef&Type=list&name=b378b1bb%2Daaa8%2D4d71%2Dbc8f%2Da7f8842ae635 Standard Operating Procedures FDA Part 11 Checklist]
* [https://univnebrmedcntr.sharepoint.com.mcas.ms/teams/FDAPart11Checklist/_layouts/15/AccessDenied.aspx?Source=https%3A%2F%2Funivnebrmedcntr%2Esharepoint%2Ecom%2Fteams%2FFDAPart11Checklist%2FShared%20Documents%2FForms%2FAllItems%2Easpx%3Fviewid%3D60e03d35%252D2539%252D439e%252Db1bb%252Dea61de066528&correlation=f5e3cca0%2Dc0ff%2D4000%2D0541%2De52ab4f3efef&Type=list&name=b378b1bb%2Daaa8%2D4d71%2Dbc8f%2Da7f8842ae635 Standard Operating Procedures FDA Part 11 Checklist]
* [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application Part 11, Electronic Records; Electronic Signatures - Scope and Application]
* [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application Part 11, Electronic Records; Electronic Signatures - Scope and Application]

Revision as of 14:16, August 14, 2023

Human Resources Safety/Security Research Compliance Compliance Privacy/Information Security Business Operations Intellectual Property Faculty

Compliance Program | Compliance Hotline | Inspections/Investigations by Third Parties | Research Integrity | Export Control | Code of Conduct | Use of Human Anatomical Material | Clinical Research and Clinical Trial Professional and Technical Fee Billing | Contracts | Conflict of Interest | Red Flag Identity Theft Prevention Program | Principles of Financial Stewardship | Human Tissue Use and Transfer | Disclosing Foreign Support and International Activities | Health Care Vendor Interactions | Credit Hour Definition | Whistleblower | Electronic Digital Signatures and Records


Policy No.: 8019

Effective Date: 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.

Additional Information

This page maintained by mh.