[Federal Register Volume 64, Number 89 (Monday, May 10, 1999)]
[Notices]
[Pages 25048-25049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11582]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0228]
Guidance for Industry: Computerized Systems Used in Clinical
Trials; 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 document entitled
[[Page 25049]]
``Guidance for Industry: Computerized Systems Used in Clinical
Trials.'' The guidance document provides guidance for computerized
systems used to create, modify, maintain, archive, retrieve, or
transmit clinical data intended for submission to FDA. Whether
collected or reported electronically or in paper form, clinical data
must meet certain quality standards, and this guidance is intended to
provide information on how computerized systems can meet these
standards.
DATES: Written comments on the guidance may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the guidance
entitled ``Guidance for Industry: Computerized Systems Used in Clinical
Trials'' to the Division of Compliance Policy (HFC-230), Office of
Enforcement, Office of Regulatory Affairs (ORA), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-
addressed adhesive label to assist the office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document. Submit written comments on the
guidance document to the Dockets Management Branch (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: James F. McCormack, Division of
Compliance Policy (HFC-230), Office of Enforcement, Office of
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0425.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Industry: Computerized Systems Used in Clinical
Trials.'' This guidance pertains to long-standing regulations covering
clinical trial records under 21 CFR parts 300, 500, and 800. On March
20, 1997 (62 FR 13430), FDA published a regulation providing uniform,
enforceable, baseline standards for electronic records and electronic
signatures, codified in 21 CFR part 11. To formulate supplemental
guidance on the use of computerized systems in clinical trials, an
agency working group representing the Bioresearch Monitoring Program
Managers from each center within FDA and the Office of Regulatory
Affairs prepared a draft of this present guidance. In the Federal
Register of June 18, 1997 (63 FR 33094), FDA published the draft
guidance which allowed 60 days for public comment. Upon petition, FDA
extended the comment period for an additional 60 days. FDA received
more than 500 comments from 24 respondents. Over the following 12
months, the agency working group reviewed all public comments and made
appropriate changes to the guidance.
This guidance document represents the agency's current thinking on
computerized systems used in 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.
As with other guidance documents, FDA does not intend this document to
be all-inclusive and cautions that not all information contained in the
guidance document may be applicable to all situations. The document is
intended to provide useful information and does not set forth
requirements.
II. Comments
Interested persons, may, at any time, submit to the Dockets
Management Branch (address above) written comments regarding this
guidance document. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments should be
identified with the docket number found in brackets in the heading of
this document. A copy of the guidance and received comments are
available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the guidance using
the World Wide Web (WWW). For WWW access, connect to the Office of
Regulatory Affairs at ``http://www.fda.gov/ora/compliance__ref/bimo/
default.html''.
Dated: May 3, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-11582 Filed 5-7-99; 8:45 am]
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