[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]
BILLING CODE 4160-01-F