Notice2023-05362
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Draft Guidance for Industry; Availability
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Published
March 16, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers." The draft guidance provides information for sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested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 under FDA regulations. This draft guidance revises the draft guidance for industry issued in June 2017 entitled "Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR part 11-- Questions and Answers" and, when finalized, will supersede the guidance for industry entitled "Computerized Systems Used in Clinical Investigations" (May 2007).
Full Text
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<title>Federal Register, Volume 88 Issue 51 (Thursday, March 16, 2023)</title>
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[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16268-16270]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05362]
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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in Clinical Investigations: Questions and Answers; Draft Guidance for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the availability of a draft guidance for industry entitled ``Electronic
Systems, Electronic Records, and Electronic Signatures in Clinical
Investigations: Questions and Answers.'' The draft guidance provides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 under FDA
regulations. This draft guidance revises the draft guidance for
industry issued in June 2017 entitled ``Use of Electronic Records and
Electronic Signatures in Clinical Investigations Under 21 CFR part 11--
Questions and Answers'' and, when finalized, will supersede the
guidance for industry entitled ``Computerized Systems Used in Clinical
Investigations'' (May 2007).
DATES: Submit either electronic or written comments on the draft
guidance by May 15, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
[[Page 16269]]
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 the draft 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; 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; or
Office of Policy, Guidance and Policy Development, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, 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 draft 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#1550797c6f747770617d3b5e607b7e7a667e7c557371743b7d7d663b727a63"><span class="__cf_email__" data-cfemail="7431181d0e151611001c5a3f011a1f1b071f1d341210155a1c1c075a131b02">[email protected]</span></a>; Diane Maloney, 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, <a href="/cdn-cgi/l/email-protection#e2a68b838c87ccaf838e8d8c879ba2848683cc8a8a91cc858d94"><span class="__cf_email__" data-cfemail="387c5159565d1675595457565d41785e5c591650504b165f574e">[email protected]</span></a>; 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#eab985878bc4a18b8688aa8c8e8bc4828299c48d859c"><span class="__cf_email__" data-cfemail="99caf6f4f8b7d2f8f5fbd9fffdf8b7f1f1eab7fef6ef">[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#6d34180a180c030a433a0c030a2d0b090c4305051e430a021b"><span class="__cf_email__" data-cfemail="a0f9d5c7d5c1cec78ef7c1cec7e0c6c4c18ec8c8d38ec7cfd6">[email protected]</span></a>; the 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#b7f4e3e79af5fefaf8f7d1d3d699dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="8ccfd8dca1cec5c1c3cceae8eda2e4e4ffa2ebe3fa">[email protected]</span></a>; or Eric Nelson,
Center for Veterinary Medicine, Food and Drug Administration, 7519
Standish Pl., MPN #4, Rm. 106, HFV-230, Rockville, MD 20855, 240-402-
5642, <a href="/cdn-cgi/l/email-protection#6a2f18030944240f061905042a0c0e0b44020219440d051c"><span class="__cf_email__" data-cfemail="cd88bfa4aee383a8a1bea2a38daba9ace3a5a5bee3aaa2bb">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Electronic Systems, Electronic Records, and Electronic
Signatures in Clinical Investigations: Questions and Answers.'' The
draft 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 draft 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) provide additional recommendations on the
risk-based approach to validation of electronic systems described in
the guidance for industry ``Part 11, Electronic Records; Electronic
Signatures--Scope and Application'' (August 2003); and (3) facilitate
the use of electronic systems, electronic records, and electronic
signatures to improve the quality and efficiency of clinical
investigations.
In the Federal Register of June 21, 2017 (82 FR 28277), FDA
announced the availability of the draft guidance entitled ``Use of
Electronic Records and Electronic Signatures in Clinical
[[Page 16270]]
Investigations Under 21 CFR part 11--Questions and Answers.'' FDA
received numerous comments on the draft guidance, and those comments
were considered as the guidance was revised. A summary of changes
includes clarifying recommendations for the following: (1) using a
risk-based approach for validation of electronic systems used in
clinical investigations; (2) preparing for FDA inspections of sponsors
and CROs when electronic systems are owned, controlled, or outsourced
by the sponsors and CROs for use in clinical investigations; (3)
implementing, maintaining, and retaining audit trail information; (4)
determining the suitability of information technology (IT) service
providers contracted by sponsors or other regulated entities to provide
IT services in clinical investigations; and (5) implementing and
applying data integrity controls, data security solutions, and
electronic source data principles to digital health technology used in
clinical investigations. This guidance revises the draft guidance
issued in June 2017 and, when finalized, will supersede the guidance
for industry entitled ``Computerized Systems Used in Clinical
Investigations'' (May 2007).
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by the OMB under the PRA. The
collections of information in 21 CFR part 11 have been approved under
OMB control number 0910-0303; the collections of information in 21 CFR
part 56 have been approved under OMB control number 0910-0130; 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
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 draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance">https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance</a>, <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05362 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P
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