[Federal Register: May 10, 2007 (Volume 72, Number 90)]
[Notices]
[Page 26638-26639]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my07-90]
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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in Clinical Trials,'' dated April 1999; finalizes the draft guidance of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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/gcp or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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