[Federal Register Volume 59, Number 152 (Tuesday, August 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19360]
[[Page Unknown]]
[Federal Register: August 9, 1994]
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[Docket No. 94N-0197]
International Conference on Harmonisation; Draft Document on
Essential Documents for the Conduct of a Clinical Study; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing a draft
document entitled ``Guideline for Essential Documents for the Conduct
of a Clinical Study.'' The draft document describes documents that
individually and collectively permit evaluation of the conduct of a
clinical study and the quality of the data produced. This document was
prepared by the Efficacy Expert Working Group of the International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH). The draft document is intended
to help ensure that essential documents meet good clinical practice
standards and all applicable regulatory requirements. The concepts in
this draft document will later be incorporated into a larger document
on good clinical practices.
DATES: Written comments by October 11, 1994.
ADDRESSES: Submit written comments on the draft document to the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Regarding the draft document: Bette L. Barton, Center for Drug
Evaluation and Research (HFD-344), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1032.
Regarding the ICH: Janet Showalter, Office of Health Affairs (HFY-
20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-443-1382.
SUPPLEMENTARY INFORMATION: In recent years, many important initiatives
have been undertaken by regulatory authorities and industry
associations to promote international harmonization of regulatory
requirements. FDA has participated in many meetings designed to enhance
harmonization and is committed to seeking scientifically based
harmonized technical procedures for pharmaceutical development. One of
the goals of harmonization is to identify and then reduce differences
in technical requirements for drug development.
ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are: The European
Commission, the European Federation of Pharmaceutical Industry
Associations, the Japanese Ministry of Health and Welfare, the Japanese
Pharmaceutical Manufacturers Association, FDA, and the U.S.
Pharmaceutical Research Manufacturers of America. The ICH Secretariat,
which coordinates the preparation of documentation, is provided by the
International Federation of Pharmaceutical Manufacturers Associations
(IFPMA).
The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, the Canadian Health Protection Branch, and the
European Free Trade Area.
At a meeting held on October 27, 1993, the ICH Steering Committee
agreed that the following draft document entitled ``Guideline for
Essential Documents for the Conduct of a Clinical Study'' should be
made available for public comment. This draft document is the product
of the Efficacy Expert Working Group of the ICH. ``Essential
documents'' individually and collectively permit evaluation of the
conduct of a study and the quality of the data produced. The draft
document describes the purpose of each document and states whether the
document should be filed in the investigator's files or the sponsor's
files. Comments about this draft will be considered by FDA and the
Efficacy Expert Working Group of the ICH. Modifications will appear in
a larger draft document on good clinical practices. Ultimately, FDA
intends to adopt the ICH Steering Committee's final guidelines and
recommendations.
Although not required, FDA would normally provide at least a 75-day
comment period and preferably a 90-day comment period to provide
interested persons with ample time to review and comment upon this type
of an action. However, the comment period for this guideline has been
shortened to 60 days so that comments may be received by FDA in time to
be discussed at an October 1994 meeting involving this guideline.
Guidelines are generally issued under Sec. 10.90(b) (21 CFR
10.90(b)), which provides for the use of guidelines to state procedures
or standards of general applicability that are not legal requirements
but that are acceptable to FDA. The agency is now in the process of
revising Sec. 10.90(b). Therefore, this guideline if made final would
not be issued under current Sec. 10.90(b), and it would not create or
confer any rights, privileges, or benefits for or on any person, nor
would it operate to bind FDA in any way.
Interested persons may, on or before October 11, 1994, submit to
the Dockets Management Branch (address above) written comments on the
draft document. 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. The draft document and received comments may be seen in the
office above between 9 a.m. and 4 p.m., Monday through Friday.
The text of the draft document follows:
Guideline for Essential Documents for the Conduct of a Clinical Study
Essential Documents are those documents which individually and
collectively permit evaluation of the conduct of a study and the
quality of the data produced. These documents serve to demonstrate
the compliance of the investigator, sponsor, and monitor with the
standards of Good Clinical Practice and with all applicable
regulatory requirements.
Essential Documents also serve a number of other important
purposes. Filing essential documents at the investigator and sponsor
sites in a timely manner can greatly assist in the successful
management and quality control of a study by the investigator,
sponsor, and monitor. These documents are also the ones which are
usually audited by the sponsor's quality assurance function or
inspected by a regulatory agency as part of the process to confirm
the validity of the study conduct and the integrity of the data
collected.
The minimum list of essential documents which has been developed
follows. The various documents are grouped in three sections
according to the stage of the study during which they will normally
be generated: (1) Before the clinical phase of the study commences,
(2) during the clinical conduct of the study, and (3) after the
completion or termination of the study. A description is given of
the purpose of each document, and whether it should be filed in
either the investigator or sponsor files or both. It is acceptable
to combine some of the documents, provided the individual elements
are readily identifiable.
Good Clinical Practice provides that trial master files be
established at the beginning of the study, both at the investigator
site and at the sponsor's office. The final close out visit of a
study can only be done when the monitor has reviewed both
investigator and sponsor files and confirms that all necessary
essential documents are in the appropriate files.
Any or all of the documents addressed in this guideline may be
subject to, and should be available for, audit by the sponsor or a
nominated independent organization and/or inspection by competent
authorities.
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Dated: August 3, 1994.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 94-19360 Filed 8-8-94; 8:45 am]
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