[Federal Register Volume 89, Number 191 (Wednesday, October 2, 2024)]
[Notices]
[Pages 80255-80257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22562]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-1105]


Electronic Systems, Electronic Records, and Electronic Signatures 
in Clinical Investigations: Questions and Answers; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Electronic 
Systems, Electronic Records, and Electronic Signatures in Clinical 
Investigations: Questions and Answers.'' The guidance provides 
information for sponsors, clinical investigators, institutional review 
boards (IRBs), contract research organizations (CROs), and other 
interested parties on the use of electronic systems, electronic 
records, and electronic signatures in clinical investigations of foods, 
medical products, tobacco products, and new animal drugs. The guidance 
provides recommendations regarding the requirements in our regulations, 
pursuant to which FDA considers electronic systems, electronic records, 
and electronic signatures to be trustworthy, reliable, and generally 
equivalent to paper records and handwritten signatures executed on 
paper. This guidance finalizes the draft guidance of the same title 
issued on March 16, 2023, and supersedes the guidance for industry 
entitled ``Computerized Systems Used in Clinical Investigations'' 
issued in May 2007.

[[Page 80256]]


DATES: The announcement of the guidance is published in the Federal 
Register on October 2, 2024.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-1105 for ``Electronic Systems, Electronic Records, and 
Electronic Signatures in Clinical Investigations: Questions and 
Answers.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002 or to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Kunkoski, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3332, Silver Spring, MD 20993-0002, 301-
796-6439, <a href="/cdn-cgi/l/email-protection#8ecbe2e7f4efecebfae6a0c5fbe0e5e1fde5e7cee8eaefa0e6e6fda0e9e1f8"><span class="__cf_email__" data-cfemail="3471585d4e555651405c1a7f415a5f5b475f5d745250551a5c5c471a535b42">[email protected]</span></a>; James Myers, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911; Soma Kalb, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
G318, Silver Spring, MD 20993-0002, 301-796-6539, 
<a href="/cdn-cgi/l/email-protection#40132f2d216e0b212c22002624216e2828336e272f36"><span class="__cf_email__" data-cfemail="31625e5c501f7a505d53715755501f5959421f565e47">[email protected]</span></a>; Yuguang Wang, Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., Rm. 4A-012, 
College Park, MD 20740, 240-402-1757, <a href="/cdn-cgi/l/email-protection#bee7cbd9cbdfd0d990e9dfd0d9fed8dadf90d6d6cd90d9d1c8"><span class="__cf_email__" data-cfemail="5e072b392b3f303970093f30391e383a3f7036362d70393128">[email protected]</span></a>; Justin 
Sherren, Center for Tobacco Products, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 75, Silver Spring, MD 20993-0002, 240-
402-7970, <a href="/cdn-cgi/l/email-protection#206374700d62696d6f604644410e4848530e474f56"><span class="__cf_email__" data-cfemail="d89b8c88f59a91959798bebcb9f6b0b0abf6bfb7ae">[email protected]</span></a>; Eric Nelson, Center for Veterinary 
Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., 
MPN #4, Rm. 106, Rockville, MD 20855, 240-402-5642, 
<a href="/cdn-cgi/l/email-protection#8dc8ffe4eea3c3e8e1fee2e3cdebe9eca3e5e5fea3eae2fb"><span class="__cf_email__" data-cfemail="f8bd8a919bd6b69d948b9796b89e9c99d690908bd69f978e">[email protected]</span></a>; or Paul Kluetz, Oncology Center of Excellence, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 
2223, Silver Spring, MD 20993, 301-796-9567, <a href="/cdn-cgi/l/email-protection#f28293879edc999e87978688b2949693dc9a9a81dc959d84"><span class="__cf_email__" data-cfemail="1969786c753772756c7c6d63597f7d783771716a377e766f">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Electronic Systems, Electronic Records, and Electronic 
Signatures in Clinical Investigations: Questions and Answers.'' The 
guidance provides information for sponsors, clinical investigators, 
IRBs, CROs, and other interested parties on the use of electronic 
systems, electronic records, and electronic signatures in clinical 
investigations of foods, medical products, tobacco products, and new 
animal drugs. The goals of the guidance are to: (1) update 
recommendations for applying and implementing data integrity and data 
security controls, including the use of audit trails and the protection 
of records in the current environment of electronic systems used in 
clinical investigations; (2) expand upon recommendations on the risk-
based approach to validation of electronic systems described in the 
guidance for industry ``Part 11, Electronic Records; Electronic

[[Page 80257]]

Signatures--Scope and Application'' (August 2003); (3) provide 
recommendations on using information technology service providers to 
provide services during a clinical investigation; (4) provide 
recommendations regarding the collection of data through digital health 
technologies; (5) facilitate the use of electronic signatures; and (6) 
facilitate the use of electronic systems, electronic records, and 
electronic signatures to improve the quality and efficiency of clinical 
investigations.
    This guidance finalizes the draft guidance of the same title issued 
on March 16, 2023 (88 FR 16268). FDA considered comments received on 
the draft guidance as the guidance was finalized. Changes from the 
draft to the final guidance include: (1) clarifying the applicability 
of part 11 (21 CFR part 11) to real-world data sources submitted to 
FDA; (2) clarifying the applicability of part 11 to clinical 
investigations conducted outside of the United States; (3) describing 
electronic systems deployed by regulated entities in clinical 
investigations and using a risk-based approach for validation; (4) 
clarifying the focus of FDA inspections of regulated entities; (5) 
providing recommendations for agreements between information technology 
service providers and regulated entities; (6) providing recommendations 
regarding data collection from digital health technologies used in 
clinical investigations; and (7) clarifying recommendations for the use 
of electronic signatures in clinical investigations, including 
information on submission of letters of non-repudiation to certify that 
an electronic signature is the legally binding equivalent of a 
traditional handwritten signature. In addition, editorial changes were 
made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Electronic Systems, Electronic Records, 
and Electronic Signatures in Clinical Investigations: Questions and 
Answers.'' It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in part 11 have been approved under OMB control number 0910-0303; the 
collections of information in 21 CFR parts 50 and 56 have been approved 
under OMB control number 0910-0130; the collections of information in 
21 CFR part 211 have been approved under OMB control number 0910-0139; 
the collections of information in 21 CFR part 312 have been approved 
under OMB control number 0910-0014; the collections of information in 
21 CFR parts 314 and 601 have been approved under OMB control numbers 
0910-0001 and 0910-0338, respectively; the collections of information 
in 21 CFR part 511 have been approved under OMB control number 0910-
0117; and the collections of information in 21 CFR part 812 have been 
approved under OMB control number 0910-0078.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-22562 Filed 10-1-24; 8:45 am]
BILLING CODE 4164-01-P


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