[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 This guidance finalizes the draft guidance of the same title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:
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.
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:
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.
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.
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, [email protected]; 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,
[email protected]; 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, [email protected]; Justin
Sherren, Center for Tobacco Products, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 75, Silver Spring, MD 20993-0002, 240-
402-7970, [email protected]; 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,
[email protected]; 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, [email protected].
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]
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