E6-3785. Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials; 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 “Using a Centralized IRB Process in Multicenter Clinical Trials.” The 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 regulations by facilitating the use of a centralized IRB review process.

DATES:

Submit written or electronic comments on agency guidances 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 (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

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, suite 200N, Rockville, MD 20852-1448, 301-827-6210, or

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

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 28, 2005 (70 FR 15635), FDA published a notice announcing the availability of a draft guidance entitled “Using a Centralized IRB Process in Multicenter Clinical Trials.” The notice gave interested persons an opportunity to submit comments by May 27, 2005. The agency received only a small number of comments, and we carefully considered the received comments as we finalized the draft guidance. Other than minor editorial changes and some clarifications, no substantive changes were made to the draft guidance.

This 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 guidance does the following: (1) Describes the roles of the participants in a centralized IRB review process, (2) offers guidance on how a centralized IRB review process might consider the concerns and attitudes of the various communities participating in a multicenter clinical trial, (3) makes recommendations about documenting agreements between a central IRB and the IRBs at institutions involved in the centralized IRB review process concerning the responsibilities of a central IRB and each institution's IRB, and (4) discusses IRB procedures for implementing a centralized review process. Finally, the guidance recommends how to ensure effective IRB review for clinical trial sites not already affiliated with an IRB. This guidance applies to clinical investigations conducted under 21 CFR part 312 (investigational new drug application or IND regulations).

This level 1 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 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 guidance. Submit a single copy of electronic comments or two paper copies, 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 guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the 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.

Dated: March 7, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.