E9-25629. Guidance for Industry on Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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, [e-mail].

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 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 (§§ 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.