Notice2023-07687
A Risk-Based Approach To Monitoring of Clinical Investigations-Questions and Answers; Guidance for Industry; Availability
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Published
April 12, 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 final guidance for industry entitled "A Risk- Based Approach to Monitoring of Clinical Investigations--Questions and Answers." This guidance provides information on risk-based approaches to monitoring investigational studies of human drug and biological products, medical devices, and combination products. The guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. This guidance expands on the guidance for industry entitled "Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring" (August 2013) by providing additional information to facilitate sponsors' implementation of risk-based monitoring. This guidance finalizes the draft guidance entitled "A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers," issued on March 15, 2019.
Full Text
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<title>Federal Register, Volume 88 Issue 70 (Wednesday, April 12, 2023)</title>
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[Federal Register Volume 88, Number 70 (Wednesday, April 12, 2023)]
[Notices]
[Pages 22038-22040]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-07687]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-0362]
A Risk-Based Approach To Monitoring of 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 ``A Risk-
Based Approach to Monitoring of Clinical Investigations--Questions and
Answers.'' This guidance provides information on risk-based approaches
to monitoring investigational studies of human drug and biological
products, medical devices, and combination products. The guidance
contains recommendations on planning a monitoring approach, developing
the content of a monitoring plan, and addressing and communicating
monitoring results. This guidance expands on the guidance for industry
entitled ``Oversight of Clinical Investigations--A Risk-Based Approach
to Monitoring'' (August 2013) by providing additional information to
facilitate sponsors' implementation of risk-based monitoring. This
guidance finalizes the draft guidance entitled ``A Risk-Based Approach
to Monitoring of Clinical Investigations: Questions and Answers,''
issued on March 15, 2019.
DATES: The announcement of the guidance is published in the Federal
Register on April 12, 2023.
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: <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.
[[Page 22039]]
<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-2019-D-0362 for ``A Risk-Based Approach to Monitoring of 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 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; 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; the
Office of Policy, Guidance and Policy Development, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Room 5431, Silver Spring, MD 20993-0002; or
the Office of Clinical Policy, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993. 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: Mona Shing, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3355, Silver Spring, MD 20993-0002, 301-796-0910,
<a href="/cdn-cgi/l/email-protection#35585a5b541b465d5c5b52755351541b5d5d461b525a43"><span class="__cf_email__" data-cfemail="c3aeacada2edb0abaaada483a5a7a2edababb0eda4acb5">[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; Martin
Hamilton, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002, 301-796-5666, <a href="/cdn-cgi/l/email-protection#efacabbda7ac838681868c8e83aa99868b8a818c8aaf898b8ec187879cc1888099"><span class="__cf_email__" data-cfemail="eeadaabca6ad828780878d8f82ab98878a8b808d8bae888a8fc086869dc0898198">[email protected]</span></a>;
Sheila Brown, Office of Clinical Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5109, Silver Spring, MD 20993,
301-796-6563, <a href="/cdn-cgi/l/email-protection#faa9929f93969bd4b888958d94ba9c9e9bd4929289d49d958c"><span class="__cf_email__" data-cfemail="6d3e050804010c432f1f021a032d0b090c4305051e430a021b">[email protected]</span></a>; or Hector Colon, Office of
Regulatory Affairs/Office of Bioresearch Monitoring Operations, 12420
Parklawn Dr., Rockville, MD 20857, 301-796-3899,
<a href="/cdn-cgi/l/email-protection#e58a9784878c888a8c8b96958086918c8a8b958a86a5838184cb8d8d96cb828a93"><span class="__cf_email__" data-cfemail="fb94899a999296949295888b9e988f9294958b9498bb9d9f9ad5939388d59c948d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``A Risk-Based Approach to Monitoring of Clinical
Investigations--Questions and Answers.'' Sponsors of clinical
investigations involving human drugs, biological products, medical
devices, and combination products are required to provide oversight of
the conduct of their clinical investigations. Such oversight helps to
ensure adequate protection of the rights, welfare, and safety of human
subjects and the integrity of the data submitted to FDA. Therefore, FDA
recommends that sponsors implement a system to manage risks to human
subjects and data integrity throughout all stages of the clinical
investigation process.
This system to manage the quality of the investigation should help
ensure data integrity while safeguarding the rights, safety, and
welfare of trial participants by, for example, focusing on the design
of efficient clinical trial protocols, tools for identifying and
tracking potential risks, and procedures for data collection and
processing. This system should include a risk-based approach to
monitoring tailored to the potential risks for the specific clinical
investigation. Clinical investigation monitoring is a quality control
tool for determining whether investigation activities are being carried
out as planned, so that, among other things, deficiencies can be
identified and corrected. The types and intensity of monitoring
activities should be proportionate to the risks to participants'
rights, safety, and welfare and to data integrity inherent in the
investigation. Effective implementation of risk-based monitoring of
clinical investigations, including the prioritization of monitoring and
other oversight activities directed at processes and procedures
critical for human subject protection and maintaining data integrity,
should help maximize the quality of a clinical investigation.
This guidance finalizes the draft guidance entitled ``A Risk-Based
Approach to Monitoring of Clinical Investigations: Questions and
Answers,'' issued on March 15, 2019 (84 FR 9531). FDA considered
comments received on the draft guidance as the guidance was being
finalized and revised the guidance as appropriate in response to the
comments. Additionally, 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 ``A Risk-Based Approach to Monitoring of
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
[[Page 22040]]
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 OMB under the PRA. The collections
of information in 21 CFR part 50 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 812 have been approved under OMB control
number 0910-0078; the collections of information in 21 CFR part 11 have
been approved under OMB control number 0910-0303; and the collections
of information in FDA's guidance for industry entitled ``Oversight of
Clinical Investigations--A Risk-Based Approach to Monitoring'' have
been approved under OMB control number 0910-0733.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, <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/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>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07687 Filed 4-11-23; 8:45 am]
BILLING CODE 4164-01-P
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