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Design, execution, and management of medical device clinical trials /
An essential introduction to conducting the various stages of medical device clinical trials. Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a unif...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken, N.J. :
John Wiley & Sons,
©2009.
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 037 | |a 10.1002/9780470475911 |b Wiley InterScience |n http://www3.interscience.wiley.com | ||
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| 100 | 1 | |a Abdel-aleem, Salah. | |
| 245 | 1 | 0 | |a Design, execution, and management of medical device clinical trials / |c Salah Abdel-aleem. |
| 260 | |a Hoboken, N.J. : |b John Wiley & Sons, |c ©2009. | ||
| 300 | |a 1 online resource (xxi, 272 pages) : |b illustrations | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 347 | |a data file | ||
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a 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. | |
| 520 | |a An essential introduction to conducting the various stages of medical device clinical trials. Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, pract. | ||
| 588 | 0 | |a Print version record. | |
| 546 | |a English. | ||
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 650 | 0 | |a Medical instruments and apparatus |x Research. | |
| 650 | 0 | |a Clinical trials. | |
| 650 | 2 | |a Equipment and Supplies |x standards | |
| 650 | 2 | |a Clinical Trials as Topic |x methods | |
| 650 | 2 | |a Device Approval |x standards | |
| 650 | 2 | |a Evaluation Studies as Topic | |
| 650 | 6 | |a Médecine |x Appareils et instruments |x Recherche. | |
| 650 | 6 | |a Études cliniques. | |
| 650 | 7 | |a MEDICAL |x Instruments & Supplies. |2 bisacsh | |
| 650 | 7 | |a Clinical trials |2 fast | |
| 650 | 7 | |a Medical instruments and apparatus |x Research |2 fast | |
| 758 | |i has work: |a Design, execution, and management of medical device clinical trials (Text) |1 https://id.oclc.org/worldcat/entity/E39PCGfVjkm8X7KKc8RTgW9ppq |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 776 | 0 | 8 | |i Print version: |a Abdel-aleem, Salah. |t Design, execution, and management of medical device clinical trials. |d Hoboken, N.J. : John Wiley & Sons, ©2009 |z 9780470474266 |z 0470474262 |w (DLC) 2008049904 |w (OCoLC)275152875 |
| 856 | 4 | 0 | |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=456029 |z Texto completo |
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