Read the SMALL PRINT of the 1572

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Read the SMALL PRINT of the 1572
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Good Clinical Practice (GCP)

• 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,
• and that
• the Rights, Integrity, and Confidentiality of
  Trial Subjects are Protected.

Quality Data
Ethics
Quality Data Ethics GCP
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Obligations of Investigators Video

• A GCP Day in the life of a clinical researcher

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GCPs Discussion

• What ethics process was shown in the video?
• the Rights, Integrity, and Confidentiality of
  Trial Subjects are Protected.
• What data quality concepts were shown?
• the Data and Reported Results are Credible, and
  Accurate

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Form FDA 1572 Its the Law!

• 21 Code of Federal Regulations 312.53 (c) (1)
• Before permitting an investigator to begin
  participation in an investigation, the sponsor
  shall obtain the following
• A signed investigator statement (Form FDA-1572)

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Form FDA 1572 Location

• DHHSs Program Support Center (PSC)
  http//forms.psc.gov/
• Click on FDA for current version of 1572 (and
  instructions)
• Note In last year there have been 3 versions
• Sep 30, 2002
• Nov 30, 2002
• Jan 31, 2006

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Investigator Information
Education, Training, and Experience
Study Location
Laboratory Information
IRB Information
List of Subinvestigators
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Bioresearch Monitoring Information System
File (BMIS)

• http//www.fda.gov/oc/gcp/clinenforce.html
• Abstracts IND study information from 1572 and
  other documents
• Contains information on
• Investigators
• Contract Research Organizations (CROs)
• Institutional Review Boards (IRBs)
• Lists separate information entry each time a new
  IND is submitted

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Expiry Date
Investigator Information
Education, Training, and Experience
Study Location
Laboratory Information
IRB Information
List of Subinvestigators
Protocol/IND Number (Sponsor Information)
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IND Requirement

• Investigational New Drug 21CFR312.3
• New drug, or
• New biological drug
• New biological product used in vitro for
  diagnostic purposes
• Phase 1, 2, or 3 studies
• Administered or dispensed to, or used in, one or
  more human subjects

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(No Transcript)
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1572 Commitments Box 9

• S _______
• M ______ ______
• A _____ to _______
• L ____ __________ ________
• L et FDA Inspect
• __P__ _______ _______
• R etain Records
• I _____ _______
• N ____ _ _ _
• T ____ ______

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1572 Commitments Box 9
upervise

• S _______
• M ______ ______
• A _____ to _______
• L ____ __________ ________
• L et FDA Inspect
• __P__ _______ _______
• R etain Records
• I _____ _______
• N ____ _ _ _
• T ____ ______

aintain Records
dhere Protocol
earn Investigators Brochure
Re ort Adverse Events
nform Subjects
otify I R B
rain Staff
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1572 Commitments Box 9
upervise

• S _______
• M ______ ______
• A _____ to _______
• L ____ __________ ________
• L et FDA Inspect
• __P__ _______ _______
• R etain Records
• I _____ _______
• N ____ _ _ _
• T ____ ______

aintain Records
dhere Protocol
earn Investigators Brochure
Re ort Adverse Events
nform Subjects
otify I R B
rain Staff
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1572 Discussion Points

• For what studies is the 1572 used?
• Who can be the investigator (i.e. signatory)?
• Who can be a sub investigator (Box 6)?

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1572 Problem Cases
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FDA Warning Letters (WL)

• 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

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WL (5 Jun 02) Hassman, MD

• The investigator agreement you signed requires
  you to personally conduct or supervise the
  clinical investigation (see FDA Form 1572).
• FDAs 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.

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WL(17 Apr 02) Yu, MD, PhD

• You failed to obtain a signed investigator
  statement, Form FDA 1572
• from all investigators prior to permitting them
  to begin participation in the investigation.
• You failed to provide a complete list of the
  sub-investigators
• who assisted you in the conduct of the
  investigation.

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FDA Problem Investigators Lists

• Restricted List
• 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/restlis
  t.htm

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Restrictions List Cases
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The obligations of the 1572 must be applied to
all clinical research."

• Anonymous