[Federal Register Volume 73, Number 231 (Monday, December 1, 2008)]
[Notices]
[Pages 72807-72808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28387]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0576]
Guidance for Sponsors, Clinical Investigators, and IRBs; Data
Retention When Subjects Withdraw From FDA-Regulated Clinical Trials;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Data Retention When Subjects
Withdraw from FDA-Regulated Clinical Trials.'' This guidance clarifies
FDA's position that it is critical that data be retained from trial
participants who decide to discontinue participation in a clinical
study of an investigational product, who are withdrawn by their legally
authorized representative, as applicable, or who were discontinued from
participation by the clinical investigator. The guidance will be of
interest especially to sponsors, clinical investigators, and members of
investigational review boards (IRBs).
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written comments on the guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Sara F. Goldkind, Office of Science
and Health Coordination/Good Clinical Practice Program (HF-34), Food
and Drug Administration, 5600 Fishers Lane, Rockville MD 20857, 301-
827-3340.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for sponsors,
clinical investigators, and IRBs entitled ``Data Retention When
Subjects Withdraw from FDA-Regulated Clinical Trials.'' This guidance
clarifies FDA's long-standing position that it is critical that data be
retained from individuals who decide to discontinue participation in a
clinical study of an investigational product, or who were discontinued
from participation by the clinical investigator.
FDA developed this guidance in response to questions from sponsors,
clinical investigators, and members of IRBs about previously collected
data from subjects who withdraw or are withdrawn from clinical
investigations. This guidance describes the regulatory and statutory
basis for FDA's position, as well as the supporting ethical and quality
standards, and outlines key points regarding the withdrawal of subjects
from a clinical investigation. Because data resulting from these
clinical investigations is used to support research applications and
new product approvals, it is critical that FDA have a complete and
accurate data set. If data were to be removed from the study database,
the scientific validity of the data and thus FDA's analysis of it could
be jeopardized potentially compromising the agency's ability to
safeguard the public health.
This Level 1 guidance is being issued for immediate implementation
to prevent the potential loss of important clinical trial data. This
approach is consistent with FDA's good guidance practices regulation
(21 CFR 10.115). If comments are received on this Level 1 guidance, FDA
will review the comments and revise the guidance if appropriate. This
guidance represents the agency's long-standing policy and current
thinking on the retention of data when subjects withdraw from FDA-
regulated clinical trials. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations. Interested
persons may submit written comments on the guidance to the Division of
Dockets Management (see ADDRESSES).
Elsewhere in this issue of the Federal Register, the Office of
Human Research Protections (OHRP) is announcing the availability of a
draft guidance document entitled ``Guidance on Important Considerations
for When
[[Page 72808]]
Participation of Human Subjects in Research Is Discontinued.'' FDA
believes the interpretation provided in its guidance is consistent with
that provided in OHRP's draft guidance document.
II. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information under the investigational new drug
regulation have been approved under OMB Control No. 0910-0014. The
collections of information under the investigational device exemptions
regulation have been approved under OMB Control No. 0910-0078.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/oc/gcp/guidance.html or http://www.fda.gov/ohrms/dockets/default.htm.
Dated: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28387 Filed 11-28-08; 8:45 am]
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