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2004D-0440:GUIDANCE
FOR INDUSTRY ON COMPUTERIZED SYSTEMS USED IN 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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| EMC3
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| 12/16/2004
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| 12/16/2004
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| Drug Industry
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| Merck & Co., Inc.
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| txt,
Attachment doc,
pdf
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| Signature:
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| Brian Mayhew
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| C9
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| 12/23/2004
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| 12/16/2004
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| International Industry
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| PDA Japan
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| pdf
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| Signature:
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| Daikitiro Murakami
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| C10
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| 12/29/2004
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| 12/28/2004
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| Drug Industry
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| Purdue Pharma, L.P.
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| pdf
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| Signature:
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| Anne D. Vento
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| C11
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| 01/04/2005
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| 12/29/2004
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| Drug Industry
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| Becton, Dickinson
and Company (BD)
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| pdf
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| Signature:
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| Patricia B. Shrader,
Esq
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| C12
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| 01/03/2005
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| 12/30/2004
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| Association
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| Society
for Clinical Data Management, Inc. (SCDM)
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| pdf
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| Signature:
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| Jonathan R. Andrus,
MS, CQA
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| C13
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| 01/03/2005
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| 12/30/2004
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| Drug Industry
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| AstraZeneca Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Gary M. Cooper
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| C14
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| 01/03/2005
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| 12/30/2004
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| Drug Industry
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| F. Hoffman-LaRoche
Ltd
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| pdf
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| Signature:
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| Dr. Peter Trindler
and Dr. Peter Bossh
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| EMC4
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| 12/27/2004
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| 12/27/2004
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| Private Industry
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| Triangle PEERS
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| txt,
Attachment
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| Signature:
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| Triangle PEERS
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| EMC5
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| 01/03/2005
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| 01/03/2005
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| Private Industry
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| Phase Forward
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| txt,
Attachment
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| Signature:
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| Michael Owings
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| EMC6
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| 01/05/2005
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| 01/05/2005
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| Drug Industry
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| Biotechnology Industry
Organization (BIO)
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| txt,
Attachment
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| Signature:
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| Sara Radcliffe
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| EMC7
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| 01/04/2005
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| 01/04/2005
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| Association
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| Society of Quality
Assurance (SQA)
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| txt,
Attachment
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| Signature:
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| Krista Kerr et al.
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| C15
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| 01/06/2005
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| 01/04/2005
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| Private Industry
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| Clinical Cardiovascular
Research, LLC
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| pdf
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| Signature:
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| Shifu Zhao, PhD and
Warren Zabloud
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| C16
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| 01/10/2005
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| 01/04/2005
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| Private Industry
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| Society of Quality
Assurance (SQA)
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| pdf
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| Signature:
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| Krista Kerr et al.
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| C17
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| 01/11/2005
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| 01/11/1005
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| Drug Industry
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| pdf
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| Signature:
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| Alan Goldhammer, PhD
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Page last updated
March 22, 2005
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