| Up
2005D-0103:
Guidance for Industry on Using a Centralized IRB Process in Multicenter
Clinical Trials
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| GDL1
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| 03/25/2005
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| 03/25/2005
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| Federal Government
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| Guidance
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| pdf
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| Signature:
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| Guidance
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| NAD1
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| 03/25/2005
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| FDA
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| FDA
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| 03/28/2005
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| 15635-15636
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| 05/27/2005
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| C1
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| 04/20/2005
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| 04/18/2005
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| Individual Consumer
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| B. Lenich
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| C2
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| 04/28/2005
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| 04/22/2005
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| Health Professional
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| J. Heubi, M.D.
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| C3
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| 05/04/2005
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| 05/03/2005
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| Drug Industry
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| Methapharm, Inc.
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| pdf
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| Signature:
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| Anne Marie Hayes
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| C4
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| 05/16/2005
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| 05/12/2005
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| Private Industry
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| Memorial Blood Centers
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| pdf
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| Signature:
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| Jed B. Gorlin
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| C5
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| 05/25/2005
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| 05/24/2005
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| Private Industry
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| AstraZeneca
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| pdf
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| Signature:
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| Gary M Cooper
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| C6
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| 05/27/2005
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| 05/27/2005
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| Association
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| ASCO
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| pdf
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| Signature:
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| Sandra J. Horning, M.D.
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| C7
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| 05/27/2005
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| 05/26/2005
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| Private Industry
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| Quorum Review, Inc.
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| pdf
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| Signature:
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| Mark Mynhier
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| C8
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| 05/31/2005
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| 05/27/2005
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| Private Industry
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| Novo Nordisk
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| pdf
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| Signature:
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| Mary Ann McElligott, PhD
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| C9
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| 05/31/2005
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| 05/27/2005
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| Association
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| Council on Governmental
Relations (COGR)
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| pdf
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| Signature:
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| Katharina Phillips
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| C10
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| 06/02/2005
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| 06/02/2005
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| Private Industry
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| Department of Public
Health HIV Vaccine Trials
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| pdf
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| Signature:
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| Robert Reinhard
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| EC1
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| 06/17/2005
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| 05/26/2005
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| Drug Association
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| Pharm Res
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| pdf
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| Signature:
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| Goldhammer, Alan
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| EC2
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| 06/17/2005
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| 05/26/2005
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| Health Professional
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| Dr. Gary Chadwick
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| htm
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| EC3
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| 06/17/2005
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| 05/26/2005
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| Academia
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| Council on Governmental
Relations
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| pdf
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| Signature:
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| Phillips, Katharina
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| EC4
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| 06/17/2005
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| 05/27/2005
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| Health Care Association
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| ASCO
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| pdf
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| Signature:
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| Horning, Sandra
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| EC5
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| 06/17/2005
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| 05/27/2005
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| Association
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| Biotechnology Industry
Organization (BIO)
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| pdf
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| Signature:
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| Aronson, Debra
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| EC6
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| 06/17/2005
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| 05/27/2005
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| Other Organization
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| Consortium of Independent
Review Boards
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| pdf
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| Signature:
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| Freeman, John
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| EC7
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| 06/17/2005
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| 05/28/2005
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| Drug Industry
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| Novartis
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| pdf
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| Signature:
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| Sadowski, Wayne
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| EMC1
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| 05/26/2005
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| 05/26/2005
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| Individual Consumer
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| R Reinhard, G Broder,
T Gibson, D Crawford
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| C11
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| 05/26/2005
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| 05/24/2005
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| Private Industry
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| Quintiles Transnational
Corp
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| pdf
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| Signature:
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| Stephanie Branche
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| GDL2
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| 03/15/2006
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| 03/15/2006
|
| Federal Government
|
| Guidance
|
|
|
|
|
|
|
| pdf
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|
|
|
|
|
|
| Signature:
|
| Guidance
|
|
|
|
|
| NAD2
|
|
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| 03/15/2006
|
| FDA
|
| FDA
|
| 03/16/2006
|
| 13605-13606
|
| 03/16/2007
|
| htm
|
|
|
|
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| Signature:
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| JEFFREY SHUREN
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|
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| EC8
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| 07/05/2006
|
| 07/03/2006
|
| Individual Consumer
|
| Mr. David Lowe
|
|
|
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| htm
|
|
|
|
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| EC9
|
| 07/05/2006
|
| 07/04/2006
|
| Individual Consumer
|
| Mr. Dave Lowe
|
|
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| htm
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Top | Up
Page last updated
August 1, 2006
kk
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