[Federal Register Volume 62, Number 117 (Wednesday, June 18, 1997)]
[Notices]
[Page 33094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15992]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0228]


Draft Guidance for Industry: Computerized Systems Used in 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availability of a draft guidance document entitled ``Guidance for 
Industry: Computerized Systems Used in Clinical Trials.'' The draft 
guidance document addresses issues pertaining to computer systems used 
to generate, collect, maintain, and transmit clinical data intended for 
submission to FDA in support of marketing or research applications. The 
data, whether collected or reported electronically or in paper form, 
must meet certain quality standards, and this draft guidance document 
is intended to provide information on how these standards might be met 
by computerized systems.

DATES: Written comments on the draft guidance document may be submitted 
by August 18, 1997. General comments on the agency guidance documents 
are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Guidance for Industry: Computerized 
Systems Used in Clinical Trials'' to the Drug Information Branch (HFD-
210), Center for Drug Evaluation and Research, 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 Submit written comments on the draft guidance document to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: James F. McCormack, Office of 
Enforcement (HFC-230), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0425.

SUPPLEMENTARY INFORMATION:

 I. Background

    FDA is announcing the availability of a draft guidance document 
entitled ``Guidance for Industry: Computerized Systems Used in Clinical 
Trials.'' In the Federal Register of March 20, 1997 (62 FR 13430), FDA 
published a regulation providing criteria for electronic records and 
electronic signatures (part 11 (21 CFR part 11)). The preamble to part 
11 stated that the agency anticipated issuing supplemental guidance 
documents and would afford all interested parties the opportunity to 
comment on draft guidance documents. In light of this rule and the 
existing rules and guidance concerning clinical trials, this draft 
guidance document on the use of computerized systems in clinical trials 
has been prepared by an agency working group representing the 
Bioresearch Monitoring Program Managers from each Center within FDA and 
the Office of Regulatory Affairs, and it is available for public 
comment.
    The draft guidance document addresses issues pertaining to computer 
systems used to generate, collect, maintain, and transmit data intended 
for submission to FDA in support of marketing or research applications. 
These data have broad public health significance and, whether collected 
electronically or on paper, must be of the highest quality and 
integrity. For example, all data should be attributable, original, 
accurate, contemporaneous, and legible. The draft guidance document 
provides information intended to help establish and maintain these and 
other standards in an electronic environment.
    The draft guidance document provides specific information on 
generating and securing electronic data; establishing standard 
operating procedures; data entry, including electronic signatures, 
audit trails, and date/time stamps; system design, security, and 
dependability; system controls; personnel training; records inspection; 
and certification of electronic signatures.
    This draft 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 requirement of the applicable statute, 
regulations, or both.

II. Request for Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance document. FDA 
invites comments on whether any provisions in the guidance might 
inhibit use of computers in clinical trials. Two copies of any comments 
are to be submitted, except that individuals may submit one copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. A copy of the draft guidance document 
and received comments may be seen in the office above between 9 a.m. 
and 4 p.m., Monday through Friday.

III. Electronic Access

    An electronic version of this draft guidance document is available 
on the Internet using the World Wide Web (www) at http://www.fda.gov/
cder/guidance.htm.

    Dated: June 12, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-15992 Filed 6-17-97; 8:45 am]
BILLING CODE 4160-01-F