Guidance for Industry: Computerized Systems Used in Clinical Trials; Availability

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