[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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