The design and management of medical device clinical trials : strategies and challenges /
By: Abdel-aleem, Salah.
Publisher: Hoboken, N.J. : John Wiley, 2010Description: xvii, 250 pages ; 25 cm.Content type: text | text Media type: unmediated | unmediated Carrier type: volume | volumeISBN: 9780470602256; 9780470602256:; 0470602252.Other title: Medical device clinical trials.Subject(s): Medical instruments and apparatus -- Research | Clinical trialsDDC classification: 610.284072| Item type | Current library | Call number | Status | Date due | Barcode | Item holds |
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Standard Loan
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ATU Sligo Yeats Library Main Lending Collection | 610.284072 ABD (Browse shelf(Opens below)) | Available | 0082858 |
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Includes bibliographical references and index.
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.
Clinical trials tasks & activities are widely diverse & require certain skill sets to both plan & execute. This book offers professionals in the field of clinical research valuable information on the challenging issues of the design, execution & management of clinical trials, & how to resolve these issues effectively.