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Draft Guidance for Industry on Using a Centralized Institutional Review Boards Process in Multicenter Clinical Trials; Availability

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Using a Centralized IRB Process in Multicenter Clinical Trials.” The draft guidance is intended to assist sponsors, institutions, institutional review boards (IRBs), and clinical investigators involved in multicenter clinical research in meeting the requirements of FDA's regulations by facilitating the use of a centralized IRB review process.

DATES:

Submit written or electronic comments on the draft guidance by May 27, 2005. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; or the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests.

Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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.fda.gov/​dockets/​ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

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FOR FURTHER INFORMATION CONTACT:

Nancy Stanisic, Center for Drug Evaluation and Research (HFD-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1660; or

Steve Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210, 301-827-7975; or

Dave Lepay, Good Clinical Practice Program, Office of Science and Health Coordination (HF-34), Office of the Commissioner, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340.

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SUPPLEMENTARY INFORMATION:

FDA is announcing the availability of a draft guidance for industry entitled “Using a Centralized IRB Review Process in Multicenter Clinical Trials.” The draft guidance is intended to assist sponsors, institutions, IRBs, and clinical investigators involved in multicenter clinical research in meeting the requirements of 21 CFR part 56 by facilitating the use of a centralized IRB review process. The draft guidance: (1) Describes the roles of the participants in a centralized IRB review process; (2) offers guidance on how a centralized IRB review process might address local aspects of IRB review; (3) makes recommendations about documenting agreements between a central IRB and the IRBs at institutions involved in the centralized IRB review process concerning their respective responsibilities; and (4) makes recommendations concerning written procedures for implementing a centralized review process. Finally, the draft guidance discusses using a central IRB at clinical trial sites not already affiliated with an IRB.

This draft guidance applies to clinical investigations conducted under 21 CFR part 312 (investigational new drug application or IND regulations).

This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance represents the agency's current thinking on this topic. 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. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the draft guidance. Two copies of any mailed comments are to be submitted, 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. The draft guidance and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

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III. Electronic Access

Persons with access to the Internet may obtain the draft guidance at http://www.fda.gov/​cder/​guidance/​index.htm, http://www.fda.gov/​cber/​guidelines.htm, or http://www.fda.gov/​ohrms/​dockets/​default.htm.

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Dated: March 17, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 05-5977 Filed 3-25-05; 8:45 am]

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