Design, execution, and management of medical device clinical trials /

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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...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Abdel-aleem, Salah
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, N.J. : John Wiley & Sons, ©2009.
Temas:
Medical instruments and apparatus > Research.
Clinical trials.
Equipment and Supplies > standards
Clinical Trials as Topic > methods
Device Approval > standards
Evaluation Studies as Topic
Médecine > Appareils et instruments > Recherche.
Études cliniques.
MEDICAL > Instruments & Supplies.
Clinical trials
Medical instruments and apparatus > Research
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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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