Electronic Digital Signatures and Records: Difference between revisions

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Policy No.: '''8019'''
Policy No.: '''8019'''<br>
Effective Date: 08/14/23 '''Draft''' <br>
Revised Date:  <br>
Reviewed Date: <br>


Effective Date: 08/14/23 '''Draft'''


Revised Date: 
'''<big>Electronic, Digital Signatures and Records - FDA Regulated Research</big>'''<br>


Reviewed Date:
'''<big>Electronic, Digital Signatures and Records - FDA Regulated Research</big>'''
==Basis for Policy==
==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 [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 | FDA] pertaining to FDA regulated research must be followed.
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 [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 | FDA] pertaining to FDA regulated research must be followed.
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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 [https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200?toc=1 Uniform Guidance 2 CFR Part 200]. UNMC will also comply with regulations issued by sponsoring agencies as they relate to grants and contracts.
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 [https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200?toc=1 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 [https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11 PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES] regulations as defined in the [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application FDA’s guidelines and interpretation] of scope and application.
* UNMC is beholden to the scope and general provisions outlined in the [https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11 PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES] regulations as defined in the [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application FDA’s guidelines and interpretation] of scope and application.
** '''Authority:''' [https://www.govinfo.gov/content/pkg/USCODE-2021-title21/pdf/USCODE-2021-title21-chap9-subchapII-sec321.pdf 21 U.S.C. 321–393]; [https://www.govinfo.gov/content/pkg/USCODE-2021-title42/pdf/USCODE-2021-title42-chap6A-subchapII-partF-subpart1-sec262.pdf 42 U.S.C. 262].
** '''Authority:''' [https://www.govinfo.gov/content/pkg/USCODE-2021-title21/pdf/USCODE-2021-title21-chap9-subchapII-sec321.pdf 21 U.S.C. 321–393]; [https://www.govinfo.gov/content/pkg/USCODE-2021-title42/pdf/USCODE-2021-title42-chap6A-subchapII-partF-subpart1-sec262.pdf 42 U.S.C. 262].
** '''Source:''' [https://www.federalregister.gov/documents/1997/03/20/97-6833/electronic-records-electronic-signatures 62 FR 13464], Mar. 20, 1997, unless otherwise noted.
** '''Source:''' [https://www.federalregister.gov/documents/1997/03/20/97-6833/electronic-records-electronic-signatures 62 FR 13464], Mar. 20, 1997, unless otherwise noted.
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* [https://info.unmc.edu/blog/researchops/category/researchdata/ Safeguarding Research Data]
* [https://info.unmc.edu/blog/researchops/category/researchdata/ Safeguarding Research Data]


This page maintained by [Mailto:mhurlocker@unmc.edu mh]].
This page maintained by [Mailto:mhurlocker@unmc.edu mh].

Revision as of 12:03, August 23, 2023

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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.

Additional Information

This page maintained by mh.

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