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2005N-0038:
REPORTING OF ADVERSE EVENTS TO INSTITUTIONAL REVIEW BOARDS; PUBLIC
HEARING
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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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| EC17
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| 04/13/2005
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| 04/01/2005
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| Health Professional
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| South Georgia Medical
Center
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| htm
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| Signature:
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| Heddon, Mary Ann
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| EC18
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| 04/13/2005
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| 04/07/2005
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| Health Professional
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| Univ Of
Mississsippi MedCent.Clinical ResearchProg
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| htm
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| Signature:
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| Adair, Catherine
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| EC19
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| 04/13/2005
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| 04/07/2005
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| Academia
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| University of Pittsburgh
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| pdf
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| Signature:
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| Juhl, Randy
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| EC20
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| 04/13/2005
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| 04/11/2005
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| Health Professional
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| UConn Health Center
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| pdf
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| Signature:
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| DeMeo, Margaret
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| EC21
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| 04/13/2005
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| 04/12/2005
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| Health Professional
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| Scripps Cancer Center
IRB
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| pdf
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| Signature:
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| Bjork, Jr, Robert
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| EMC4
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| 04/01/2005
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| 04/01/2005
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| Health Professional
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| South Georgia Medical
Cente
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| htm
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| Signature:
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| Mary Ann Heddon
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| EMC5
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| 04/11/2005
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| 04/11/2005
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| Private Industry
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| Scripps Cancer Center
Institute
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| 3
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| Signature:
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| Robert Bjork Jr MD
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| C4
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| 04/14/2005
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| 04/11/2005
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| Private Industry
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| Scripps Cancer Center
Institutional Review Board
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| 3
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| Signature:
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| Robert L. Bjork, Jr., MD
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| C5
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| 04/21/2005
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| 04/20/2005
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| Private Industry
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| Cook Group, Inc. (Cook)
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| 3
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| Signature:
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| Merry Lee Bain
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| C6
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| 04/21/2005
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| 04/20/2005
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| Drug Industry
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| GlaxoSmithKline (GSK)
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| 3
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| Signature:
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| Edward N. Pattishall, MD, MPH
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| C7
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| 04/21/2005
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| 04/19/2005
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| Drug Industry
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| MedImmune, Inc.
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| 3
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| Signature:
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| Samuel Yonren, MD
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| C8
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| 04/21/2005
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| 04/20/2005
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| Drug Industry
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| AstraZeneca, LP
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| 3
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| Signature:
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| Judith Molt
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| C9
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| 04/21/2005
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| 04/20/2005
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| Drug Industry
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| Novartis Pharmaceuticals
Corporation (Novartis)
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| 3
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| Signature:
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| Judith M. Sills, PharmD
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| C10
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| 04/25/2005
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| 04/20/2005
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| Individual Consumer
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| R. Reinhard
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| 3
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| Signature:
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| Robert Reinhard
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| C11
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| 04/22/2005
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| 04/21/2005
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| Private Industry
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| Quorum Review, Inc.
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| 3
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| Signature:
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| Mark Mynhier
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| C12
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| 04/22/2005
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| 04/21/2005
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| Drug Industry
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| Abbott Laboratories
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| 3
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| Signature:
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| April Veoukas, J.D.
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| EC22
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| 05/02/2005
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| 04/14/2005
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| Health Professional
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| Dana Farber/Partners
Cancer Care
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| htm
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| Signature:
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| Siegmann, Glenn
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| EC23
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| 05/02/2005
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| 04/18/2005
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| Drug Industry
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| MedImmune Inc.
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| pdf
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| Signature:
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| Yonren, Samuel
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| EC24
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| 05/02/2005
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| 04/19/2005
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| Health Professional
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| Univ. of Mississippi
Medical Center
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| htm
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| Signature:
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| Herndon, Robert
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Page last updated
June 20, 2005
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