[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Draft Guidance for Industry: Computerized Systems Used in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availability of a draft guidance document entitled ``Guidance for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 The draft
guidance document addresses issues pertaining to computer systems used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must meet certain quality standards, and this draft guidance document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DATES: Written comments on the draft guidance document may be submitted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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Guidance for Industry: Computerized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 Submit written comments on the draft guidance document to the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SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.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FDA is announcing the availability of a draft guidance document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
