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<table style="background:#F8FCFF; text-align:center" width="100%" cellspacing="0" cellpadding="0" border="0"><tr><td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Human Resources]]</td><td style="border-bottom:2px solid #A3B1BF" width="3"> </td><td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Safety/Security]]</td><td style="border-bottom:2px solid #A3B1BF" width="3"> </td><td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Research Compliance]]</td><td style="border-bottom:2px solid #A3B1BF" width="3"> </td><td style="padding:0.5em; background-color:white; line-height:0.95em; border:solid 2px #A3B1BF; border-bottom:0; font-weight:bold;" width="20">[[Compliance]]</td><td style="border-bottom:2px solid #A3B1BF" width="3"> </td><td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Privacy/Information Security]]</td><td style="border-bottom:2px solid #A3B1BF" width="3"> </td><td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Business Operations]]</td><td style="border-bottom:2px solid #A3B1BF" width="3"> </td><td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Intellectual Property]]</td><td style="border-bottom:2px solid #A3B1BF" width="3"> </td><td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Faculty]]</td></tr></table>[[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]] | <table style="background:#F8FCFF; text-align:center" width="100%" cellspacing="0" cellpadding="0" border="0"><tr><td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Human Resources]]</td><td style="border-bottom:2px solid #A3B1BF" width="3"> </td><td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Safety/Security]]</td><td style="border-bottom:2px solid #A3B1BF" width="3"> </td><td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Research Compliance]]</td><td style="border-bottom:2px solid #A3B1BF" width="3"> </td><td style="padding:0.5em; background-color:white; line-height:0.95em; border:solid 2px #A3B1BF; border-bottom:0; font-weight:bold;" width="20">[[Compliance]]</td><td style="border-bottom:2px solid #A3B1BF" width="3"> </td><td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Privacy/Information Security]]</td><td style="border-bottom:2px solid #A3B1BF" width="3"> </td><td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Business Operations]]</td><td style="border-bottom:2px solid #A3B1BF" width="3"> </td><td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Intellectual Property]]</td><td style="border-bottom:2px solid #A3B1BF" width="3"> </td><td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Faculty]]</td></tr></table>[[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]] | [[Utilizing Generative AI]] | ||
Policy No.: '''8019'''<br> | Policy No.: '''8019'''<br> | ||
Effective Date: 08/14/23 | Effective Date: 08/14/23<br> | ||
Revised Date: <br> | Revised Date: <br> | ||
Reviewed Date: <br> | Reviewed Date: 9/13/23<br> | ||
'''<big>Electronic, Digital Signatures and Records - FDA Regulated Research</big>'''<br> | '''<big>Electronic, Digital Signatures and Records - FDA Regulated Research</big>'''<br> | ||
==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. | ||
==Responsibilities== | ==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. | *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. | *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. | *Electronic Signatures must be facilitated and managed in a similar methodology as a wet signature on paper. | ||
==Policy== | ==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 [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. | ||
==Additional Information== | ==Additional Information== | ||
* [Mailto:devopsbrl@unmc.edu DevOps Business Relationship Leads, UNMC.]] | *[Mailto:devopsbrl@unmc.edu DevOps Business Relationship Leads, UNMC.]] | ||
* [https:// | *[https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11 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] | ||
* [https://info.unmc.edu/blog/researchops/covid19-clinical-research-information/covid19-additional-irb-guidance/ IRB Guidance for Investigators and Research Coordinators/Research Nurses] | *[https://info.unmc.edu/blog/researchops/covid19-clinical-research-information/covid19-additional-irb-guidance/ IRB Guidance for Investigators and Research Coordinators/Research Nurses] | ||
* [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]. | ||
Latest revision as of 13:15, January 16, 2024
| 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 | Utilizing Generative AI
Policy No.: 8019
Effective Date: 08/14/23
Revised Date:
Reviewed Date: 9/13/23
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
This page maintained by mh.