| Document Type
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BL
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| Record Number
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952583
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| Doc. No
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b706953
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| Main Entry
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Clive, Celine.
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| Title & Author
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Handbook of SOPs for good clinical practice /\ Celine Clive.
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| Edition Statement
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2nd ed.
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| Publication Statement
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Boca Raton :: Interpharm/CRC Press,, ©2004.
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| Page. NO
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1 online resource (270 pages) :: illustrations
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| ISBN
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0203492064
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: 0849321816
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: 9780203492062
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: 9780849321818
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0849321816
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| Notes
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Revised edition of: A handbook of SOPs for good clinical practice / Donald E. Maynard, B. Joyce Baird. c1996.
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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Front Cover; Table of Contents; MON-001.0: Preparation, Issue, and Revision of Standard Operating Procedures (SOPs); MON-002.0: Training Clinical Research Staff; MON-003.0: Selecting Investigators and Study Sites; MON-004.0: Developing Informed Consent Forms; MON-005.0: Conducting Site Evaluation Visits; MON-006.0: Conducting Study Initiation Visits; MON-007.0: Conducting Periodic Site Visits; MON-008.0: Reviewing Case Report Forms at the Study Site; MON-009.0: Reviewing Regulatory Documents; MON-010.0: Adverse Experiences (AEs), Serious Adverse Experiences (SAEs), and IND Safety Reports.
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| Abstract
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Completely revised and updated, this second edition of a classic handbook provides templates of SOPs ready for immediate adaptation to readers' requirements, allowing them to benchmark their existing SOPs against an internationally accepted set of SOPs. It includes a CD-ROM containing an electronic copy of each of the SOPs and forms in the handbook so that readers can easily modify the text to reflect their organization's processes. The language ranges from the specific to the very general, depending on the activity described and the number of the existing regulations governing it. The handboo.
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| Subject
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Clinical trials, Forms, Handbooks, manuals, etc.
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| Subject
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Clinical trials-- Standards, Handbooks, manuals, etc.
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Clinical trials-- Standards.
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Clinical trials.
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MEDICAL-- Laboratory Medicine.
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Research-- standards.
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Clinical Trials-- standards.
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Human Experimentation-- standards.
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| Subject
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Legislation, Drug.
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| Dewey Classification
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610/.72/4
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| LC Classification
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R853.C55C585 2004eb
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| NLM classification
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2004 E-403
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W 49C642h 2004
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| Added Entry
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Maynard, Donald E.
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| Parallel Title
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Handbook of standard operating procedures for good clinical practice
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