Read the SMALL PRINT of the 1572

The Essential GCP Document

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

Obligations of Investigators Video

A “GCP Day” in the life of a clinical researcher

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

Form FDA 1572: It’s 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:1) A signed investigator statement (Form FDA-1572)

Form FDA 1572: Location

DHHS’s 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

Investigator Information

Education, Training, and Experience

Study Location

Laboratory Information

IRB Information

List of Subinvestigators

Expiry Date

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

Expiry Date

Investigator Information

Education, Training, and Experience

Study Location

Laboratory Information

IRB Information

List of Subinvestigators

Protocol/IND Number (Sponsor Information)

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

Clinical Phase

Filing Instructions

Investigator Signatureand Date

Commitments• S• M• A• L• L

• P• R• I• N•T

1572 Commitments: Box 9

S _______ M ______ ______ A _____ to _______ L ____ __________ ________ L et FDA Inspect

__P__ _______ _______ R etain Records I _____ _______ N ____ _ _ _ T ____ ______

1572 Commitments: Box 9

S _______ M ______ ______ A _____ to _______ L ____ __________ ________ L et FDA Inspect

__P__ _______ _______ R etain Records I _____ _______ N ____ _ _ _ T ____ ______

upervise

aintain Recordsdhere Protocolearn Investigator’s Brochure

Re ort Adverse Events

nform Subjects

otify I R Brain Staff

1572 Commitments: Box 9

S _______ M ______ ______ A _____ to _______ L ____ __________ ________ L et FDA Inspect

__P__ _______ _______ R etain Records I _____ _______ N ____ _ _ _ T ____ ______

upervise

aintain Recordsdhere Protocolearn Investigator’s Brochure

Re ort Adverse Events

nform Subjects

otify I R Brain Staff

Data Quality

Ethics

PeopleNeeds

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)?

1572 Problem Cases

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

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). – 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

“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.”

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/restlist.htm

Restrictions List: Cases

David P. Faxon, MD, Los Angeles, CA

CDER R 19-Jun-2002

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 Katz, MD, New York, NY

CDER R 23-Aug-2002

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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