E8-28387. 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.

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trial participants who decide to discontinue participation in a clinical study of an investigational product, who are withdrawn by their legally authorized representative, as applicable, or who were discontinued from participation by the clinical investigator.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sponsors, clinical investigators, and members of IRBs about previously collected data from subjects who withdraw or are withdrawn from clinical investigations.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 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.