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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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| GDL1
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| 09/29/2004
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| 09/29/2004
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| Federal
Government
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| Guidance
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| doc,
pdf
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| Signature:
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| Guidance
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| NAD1
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| 09/29/2004
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| FDA
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| FDA
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| 10/04/2004
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| 59239-59240
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| 01/03/2005
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| EMC1
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| 10/14/2004
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| 10/14/2004
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| Individual Consumer
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| B. Sachau
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| Signature:
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| B. Sachau
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| EMC2
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| 10/14/2004
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| 10/14/2004
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| Individual Consumer
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| B. Sachau
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| Signature:
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| B. Sachau
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| EC1
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| 10/15/2004
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| 10/14/2004
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| Private Industry
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| CRF Inc.
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| htm,
Attachment
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| Signature:
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| Gogates, Gregory
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| C1
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| 11/18/2004
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| 11/08/2004
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| Drug Industry
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| Aventis Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Steve Caffe, MD
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| C2
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| 12/01/2004
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| 11/24/2004
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| Association
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| International Assn for Phamaceutical Science and Technology (PDA)
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| pdf
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| Signature:
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| Victoria Ann Dedrick
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| EC2
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| 12/16/2004
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| 12/15/2004
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| Drug Industry
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| GlaxoSmithKline
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| htm
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| Signature:
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| Stokley, M.S.P.H.,
Anne
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| EC3
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| 12/18/2004
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| 12/17/2004
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| Drug Industry
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| H. Lundbeck A/S
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| htm
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| Signature:
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| Rosendal, Jesper
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| EC4
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| 12/22/2004
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| 12/21/2004
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| Drug Industry
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| TAP Pharmaceutical
Products Inc.
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| htm
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| Signature:
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| Edwards, S. Albert
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| C3
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| 12/21/2004
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| 12/17/2004
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| Private Industry
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| Animal Health Institute
(AHI)
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| pdf
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| Signature:
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| Alexander S. Mathews
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| C4
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| 12/17/2004
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| 12/14/2004
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| Association
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| ISPE
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| pdf
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| Signature:
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| Bob Best
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| C5
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| 12/16/2004
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| 12/15/2004
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| Drug Industry
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| GlaxoSmithKline (GSK)
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| pdf
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| Signature:
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| Anne N. Stokley, M.S.P.H.
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| C6
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| 12/22/2004
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| 12/21/2004
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| Private Industry
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| Genentech
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| pdf
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| Signature:
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| Robert L. Garnick,
PhD
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| C7
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| 12/22/2004
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| 12/21/2004
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| Drug Industry
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| Aventis Pasteur Inc.
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| pdf
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| Signature:
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| Kenneth P. Guito
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| C8
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| 12/21/2004
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| 12/17/2004
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| Drug Industry
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| Bristol-Myers Squibb
Company (BMS)
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| pdf
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| Signature:
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| Joseph Lamendola, PhD
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| EC5
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| 12/30/2004
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| 12/29/2004
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| Private Industry
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| ClinPhone
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| htm,
Attachment
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| Signature:
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| Ralston, Jeffrey W
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| EC6
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| 01/03/2005
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| 01/02/2005
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| Association
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| Data Quality Research
Institute
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| htm , Attachment
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| Signature:
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| Hopkins, Don
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| EC7
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| 01/04/2005
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| 01/03/2005
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| Drug Industry
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| PHT Corporation
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| htm,
Attachment
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| Signature:
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| Raymond, Stephen
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Page last updated
March 22, 2005
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