The design and management of medical device clinical trials : strategies and challenges /
Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how...
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| Main Author: | |
|---|---|
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Hoboken, N.J. :
John Wiley,
©2010.
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| Subjects: | |
| Online Access: | CONNECT |
MARC
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| 100 | 1 | |a Abdel-aleem, Salah. | |
| 245 | 1 | 4 | |a The design and management of medical device clinical trials : |b strategies and challenges / |c Salah Abdel-aleem. |
| 260 | |a Hoboken, N.J. : |b John Wiley, |c ©2010. | ||
| 300 | |a 1 online resource (xvii, 250 pages) | ||
| 336 | |a text |b txt |2 rdacontent | ||
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| 505 | 0 | |a Front Matter -- Challenges to the Design of Clinical Study -- Challenges to Managing the Study -- Selection of Historic Controls -- Fraud and Misconduct in Clinical Trials -- Challenges to the Regulation of Medical Device -- Challenges of Global Clinical Studies and the CE Mark Process -- Challenging FDA PMA Cases -- Bioethics in Clinical Research -- Glossary of Clinical, CE Mark, and Statistical Terms -- References -- Index. | |
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a Challenges to the design of clinical study -- Challenges to managing the study -- Selection of historic controls -- Fraud and misconduct in clinical trials -- Challenges to the regulation of medical device -- Challenges of global clinical studies and the CE mark process -- Challenging FDA PMA cases -- Bioethics in clinincal research. | |
| 588 | 0 | |a Print version record. | |
| 520 | |a Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate s. | ||
| 546 | |a English. | ||
| 650 | 0 | |a Medical instruments and apparatus |x Research. | |
| 650 | 0 | |a Clinical trials. | |
| 650 | 2 | |a Clinical Trials as Topic |x methods | |
| 650 | 2 | |a Equipment and Supplies | |
| 650 | 2 | |a Device Approval | |
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| 776 | 0 | 8 | |i Print version: |a Abdel-aleem, Salah. |t Design and management of medical device clinical trials. |d Hoboken, N.J. : John Wiley, ©2010 |z 9780470602256 |w (DLC) 2009045887 |
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| 952 | f | f | |a Middle Tennessee State University |b Main |c James E. Walker Library |d Electronic Resources |t 0 |e R856.4 .A22 2010 |h Library of Congress classification |
