Transcript Not Just Another GCP Document!

Read the SMALL PRINT of the 1572
The Essential
GCP
Document
Good Clinical Practice (GCP)
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A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and reporting
of clinical trials that provides assurance that
the Data and Reported Results are Credible, and
Accurate, = Quality Data
and that
the Rights, Integrity, and Confidentiality of Trial
Subjects are Protected. = Ethics
Quality Data + Ethics = GCP
Obligations of Investigators Video
A “GCP Day” in the life of
a clinical researcher
GCPs: Discussion
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What “ethics” process was shown in the video?
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the Rights, Integrity, and Confidentiality of Trial
Subjects are Protected.
What “data quality” concepts were shown?
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the Data and Reported Results are Credible, and
Accurate
Form FDA 1572: It’s the Law!
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21 Code of Federal Regulations 312.53 (c) (1)
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Before permitting an investigator to begin
participation in an investigation, the sponsor shall
obtain the following:
1)
A signed investigator statement (Form FDA-1572)
Form FDA 1572: Location
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DHHS’s Program Support Center (PSC):
http://forms.psc.gov/
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Click on “FDA” for current version of 1572 (and
instructions)
Note: In last year there have been 3 versions
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Sep 30, 2002
Nov 30, 2002
Jan 31, 2006
Expiry Date
Investigator Information
Education, Training, and Experience
Study Location
Laboratory Information
IRB Information
List of Subinvestigators
Bioresearch Monitoring
Information System File (BMIS)
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http://www.fda.gov/oc/gcp/clinenforce.html
Abstracts IND study information from 1572 and
other documents
Contains information on:
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Investigators
Contract Research Organizations (CROs)
Institutional Review Boards (IRBs)
Lists separate information entry each time a new
IND is submitted
Expiry Date
Investigator Information
Education, Training, and Experience
Study Location
Laboratory Information
IRB Information
List of Subinvestigators
Protocol/IND Number (Sponsor Information)
IND Requirement
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Investigational New Drug [21CFR312.3]
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New drug, or
New biological drug
New biological product used in vitro for diagnostic
purposes
Phase 1, 2, or 3 studies
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Administered or dispensed to, or used in, one or
more human subjects
Clinical Phase
Commitments
•S
•M
•A
•L
•L
•P
•R
•I
•N
•T
Filing Instructions
Investigator
Signature
and Date
1572 Commitments: Box 9
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S _______
M ______ ______
A _____ to _______
L ____ __________ ________
L et FDA Inspect
__P__ _______ _______
R etain Records
I _____ _______
N ____ _ _ _
T ____ ______
1572 Commitments: Box 9
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upervise
S _______
M ______
aintain ______
Records
dhere to _______
Protocol
A _____
earn __________
Investigator’s ________
Brochure
L ____
L et FDA Inspect
Re
ort _______
Adverse Events
__P__
_______
R etain Records
nform _______
Subjects
I _____
otify _I _R _B
N ____
rain ______
Staff
T ____
1572 Commitments: Box 9
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upervise
S _______
M ______
aintain ______
Records
Data Quality
dhere to _______
Protocol
A _____
earn __________
Investigator’s ________
Brochure
L ____
L et FDA Inspect
Re
ort _______
Adverse Events
__P__
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R etain Records
nform _______
Subjects
I _____
Ethics
otify _I _R _B
N ____
rain ______
Staff
T ____
1572: Discussion Points
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For what studies is the 1572 used?
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Who can be the investigator (i.e. signatory)?
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Who can be a sub investigator (Box 6)?
1572 Problem Cases
FDA Warning Letters (WL)
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A post FDA inspection document
An informal advisory to a firm communicating
FDA's position on a matter but does not
commit FDA to taking enforcement action
http://www.fda.gov/oc/gcp/clinenforce.html
WL (5 Jun 02): Hassman, MD
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The investigator agreement you signed
requires you to personally conduct or
supervise the clinical investigation (see FDA
Form 1572).
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FDA’s investigation revealed that you failed to
adequately supervise those aspects of clinical
investigations which you did not personally conduct.
As described in more detail …, this lack of supervision
resulted in submission of false information to the
sponsor and failure to maintain adequate and accurate
case histories.
WL(17 Apr 02): Yu, MD, PhD
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“You failed to obtain a signed investigator
statement, Form FDA 1572
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from all investigators prior to permitting them to
begin participation in the investigation.”
“You failed to provide a complete list of the
sub-investigators
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who assisted you in the conduct of the
investigation.”
FDA Problem Investigators Lists
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Restricted List
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Names of all clinical investigators who have agreed
to certain restrictions with respect to their conduct of
clinical investigations
http://www.fda.gov/ora/compliance_ref/bimo/re
stlist.htm
Restrictions List: Cases
David P.
Faxon, MD,
Los Angeles,
CA
CDER
R 19-Jun2002
By consent agreement. For 3 years: Shall
not be principal investigator for more
than two (2) FDA regulated clinical
investigations at any one time (with
additional provisions); shall not be principal
clinical investigator for study that enrolls
more than 25 subjects at the site where he
is the principal investigator; and additional
provisions.
Lois Anne
CDER
Katz, MD,
New York, NY
R 23-Aug2002
For 3 years: Shall not be principal
investigator for more than one
additional study clinical investigation at
any one time; attend at least educational
programs on clinical research studies;
arrange training and education of staff
in conduct of clinical trials; provide
annual certification of compliance
“The obligations of the 1572 must
be applied to all clinical research."
Anonymous
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