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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. 2004D-0440]

# 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 “Computerized Systems Used in Clinical Investigations,” dated May 2007. This document provides to sponsors, contract research organizations, data management centers, clinical investigators, and institutional review boards, recommendations regarding the use of computerized systems in clinical investigations. Because the source data in source documentation are necessary for the reconstruction and evaluation of the trial to determine the safety and effectiveness of new human and animal drugs, and medical devices, this guidance is intended to assist in ensuring confidence in the reliability, quality, and integrity of electronic source data and source documentation, i.e., electronic records. This guidance supersedes the guidance entitled “Computerized Systems Used in Clinical Trials,” dated April 1999; finalizes the draft guidance of the same title dated September 2004; and supplements the guidance for industry entitled “Part 11, Electronic Records; Electronic Signatures—Scope and Application,” dated August 2003, and FDA's international harmonization efforts when applying guidance to source data generated at clinical study sites.

# DATES:

 Submit written or electronic comments on agency guidance at any time.

# ADDRESSES:

                         Submit written requests for single copies of this guidance to the Office of Critical Path Programs (HF-18), Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit phone requests to 800-835-4709 or 301-827-1800. 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.fda.gov/​dockets/​ecomments*. See the                         **SUPPLEMENTARY INFORMATION**                         section for electronic access to the guidance document.                    

# FOR FURTHER INFORMATION CONTACT:

 Patricia M. Beers Block, 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 industry entitled “Computerized Systems Used in Clinical Investigations.” This document provides to sponsors, contract research organizations, data management centers, clinical investigators, and institutional review boards, recommendations regarding the use of computerized systems in clinical investigations. There is an increasing use of computerized systems in clinical trials to generate and maintain source data and source documentation on each clinical trial subject. Such source data and source documentation must meet certain fundamental elements of data quality, e.g., attributable, legible, contemporaneous, original, and accurate, that are expected of paper records. FDA's acceptance of data from clinical trials for decisionmaking purposes depends on FDA's ability to verify the quality and integrity of the data during FDA onsite inspections and audits.

                    In the                     **Federal Register**                     of October 4, 2004 (69 FR 59239), FDA announced the availability of the draft guidance entitled “Computerized Systems Used in Clinical Trials,” dated September 2004. FDA considered the comments submitted to the docket in revising this guidance. This guidance supersedes the guidance of the same title dated April 1999; finalizes the draft guidance dated September 2004; and supplements the guidance for industry entitled “Part 11, Electronic Records; Electronic Signatures—Scope and Application,” dated August 2003, and FDA's international harmonization efforts when applying guidance to source data generated at clinical study sites.                

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 computerized systems used in clinical investigations. 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 21 CFR part 11 have been approved under OMB Control No. 0910-0303. The collections of information in 21 CFR 312.62 have been approved under OMB Control No. 0910-0014. The collections of information in 21 CFR 511.1(b)(7)(ii) have been approved under OMB Control No. 0910-0117. The collections of information in 21 CFR 812.140 have been approved under OMB Control No. 0910-0078.

## III. Comments

                    Interested persons may, at any time, 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/​oc/​gcp*                     or                     *http://www.fda.gov/​ohrms/​dockets/​default.htm*.                

      ( print page 26639)    
Dated: May 4, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. E7-9056 Filed 5-9-07; 8:45 am]

BILLING CODE 4160-01-S