[Federal Register Volume 72, Number 90 (Thursday, May 10, 2007)]
[Notices]
[Pages 26638-26639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9056]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0440]


Guidance for Industry on Computerized Systems Used in Clinical 
Investigations; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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in Clinical Trials,'' dated April 1999; finalizes the draft guidance of 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.


[[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