An edition of Design, execution, and management of medical device clinical trials
(2009)
Design, execution, and management of medical device clinical trials
by Salah Abdel-aleem
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| Edition | Availability |
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1
Design, Execution, and Management of Medical Device Clinical Trials
2009, Wiley & Sons, Incorporated, John
in English
128227905X 9781282279056
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2
Design, execution, and management of medical device clinical trials
2009, John Wiley & Sons
in English
0470474262 9780470474266
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WorldCat
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Book Details
Table of Contents
An overview of clinical study tasks and activities
Development of the clinical protocol 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 & 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.
Edition Notes
Includes bibliographical references and index.
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| December 20, 2020 | Edited by MARC Bot | import existing book |
| August 20, 2020 | Edited by ImportBot | import existing book |
| December 4, 2010 | Edited by Open Library Bot | Added subjects from MARC records. |
| January 29, 2010 | Edited by WorkBot | add more information to works |
| December 11, 2009 | Created by WorkBot | add works page |