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[Federal Register Volume 74, Number 205 (Monday, October 26, 2009)]
[Notices]
[Pages 55052-55053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25629]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0307 (formerly Docket No. 2007-D-0173)]

Guidance for Industry on Investigator Responsibilities--
Protecting the Rights, Safety, and Welfare of Study Subjects; 
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 for industry entitled ``Investigator 
Responsibilities--Protecting the Rights, Safety, and Welfare of Study 
Subjects.'' This guidance is intended to assist investigators in 
meeting their responsibilities with respect to protecting human 
subjects and ensuring the integrity of data in the conduct of clinical 
investigations. The guidance also clarifies FDA's expectations 
concerning the investigator's responsibility for supervising a clinical 
study in which some study tasks are delegated to employees of the 
investigator or to outside parties.

DATES:  Submit written or electronic comments on agency guidances at 
any time.

ADDRESSES:  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, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
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:  Joseph Griffin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 4204, Silver Spring, MD 20993, 301-796-
2270, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Investigator Responsibilities--Protecting the Rights, 
Safety, and Welfare of Study Subjects.'' Under the regulations in part 
312 (21 CFR part 312) (Investigational New Drug Application) and part 
812 (21 CFR part 812) (Investigational Device Exemptions), an 
investigator is responsible for ensuring that a clinical investigation 
is conducted according to the signed investigator statement, the

[[Page 55053]]

investigational plan, and applicable regulations; for protecting the 
rights, safety, and welfare of subjects under the investigator's care; 
and for the control of drugs, biological products, and devices under 
investigation (Sec. Sec.  312.60 and 812.100). This guidance clarifies 
the responsibilities of investigators in the conduct of clinical 
investigations conducted under parts 312 and 812, particularly the 
responsibilities to supervise the conduct of the clinical 
investigation, and to protect the rights, safety, and welfare of study 
participants in drug, biologic, and medical device clinical trials. The 
guidance also provides recommendations on how investigators should 
supervise the study-related actions of persons not in the direct employ 
of the investigator, including certain study staff and parties 
conducting associated testing and assessments.
    On May 10, 2007 (72 FR 26639), FDA issued a draft of this guidance 
with the goal of received input from the public. During the 
finalization of this guidance, FDA carefully considered all substantive 
comments concerning the content of the guidance. During finalization, 
FDA's major emphasis was on clarifying issues that were identified as 
confusing and correcting apparent errors. These efforts resulted in 
relatively minor changes throughout the guidance. FDA also removed a 
significant amount of content from the background section because it 
was duplicative of content in the guidance appendices. FDA also 
reordered section III.A.3 of the guidance concerning adequate 
supervision of the conduct of a clinical trial to make the sequence 
more logical. We reversed the order of presentation so that the section 
begins with the factors that may predispose to inadequate supervision, 
and ends with the steps that could be taken to mitigate the potential 
for inadequate supervision.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on investigator responsibilities. 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.

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 in part 312 have been approved under OMB 
control number 0910-0014; and the collections of information in part 
812 have been approved under OMB control number 0910-0078. The 
information requested for general investigator responsibilities is 
covered by the collection of information in FDA's regulations for 
investigational new drug applications (part 312) and investigational 
device exemptions (part 812) and FDA Form 1572. The guidance also 
refers to FDA's requirements in 21 CFR parts 11, 50, 54, and 56 for the 
conduct of clinical trials of drugs, biologics, and medical devices. 
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 54 have been approved under OMB control number 0910-0396; 
and the collections of information in 21 CFR part 56 (including 
information required under 21 CFR part 50) have been approved under OMB 
control number 0910-0130. The collection of information for form FDA 
3674 has been approved under OMB control number 0910-0616.

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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: October 20, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25629 Filed 10-23-09; 8:45 am]
BILLING CODE 4160-01-S
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