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" Design, execution, and management of medical device clinical trials / "
Salah Abdel-aleem
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BL
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| Record Number
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597933
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| Doc. No
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GBA956403b427152
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| Main Entry
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Abdel-aleem, Salah
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| Title & Author
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Design, execution, and management of medical device clinical trials /\ Salah Abdel-aleem
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| Publication Statement
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Hoboken, N.J. :: John Wiley & Sons,, c2009
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| Page. NO
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xxi, 272 p. :: ill. ;; 25 cm
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| ISBN
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9780470474266 (cloth)
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: 0470474262 (cloth)
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: 9780470475911
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: 0470475919
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| Bibliographies/Indexes
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Includes bibliographical references and index
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| Contents
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An overview of clinical study tasks and activities -- Development of the clinical protocols, case report forms, clinical standard operating procedures, informed consent form, study regulatory binder, study research agreement, and other clinical materials -- Qualification/selection of investigators and study monitoring visits -- Adverse events definitions and reporting procedures -- Statistical analysis plan (SAP) and biostastics in clinical research -- Final clinical study report -- Medical device regulations, combination product, study committees, and FDA-sponsor meetings -- Design issues in medical device studies -- Investigator-initiated clinical research -- Ethical conduct for human research -- Glossary of clinical trial and statistical terms
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| Subject
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Medical instruments and apparatus-- Research
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Clinical trials
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Equipment and Supplies-- standards
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Clinical Trials as Topic-- methods
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Device Approval-- standards
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Evaluation Studies as Topic
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| Dewey Classification
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610.28/4
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| LC Classification
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R856.4.A23 2009
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| NLM classification
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2009 J-792
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W 26A135d 2009
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