Document ID: FDA-2008-D-0576-0001
Agency: fda
Document Type: Notice
Title: Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw From FDA-Regulated Clinical Trials; Availability
Posted Date: 2008-12-01T05:00Z

[Federal Register: December 1, 2008 (Volume 73, Number 231)]
[Notices]               
[Page 72807-72808]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de08-75]                         

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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study of an investigational product, who are withdrawn by their legally 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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