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Design, execution, and management of medical device clinical trials [electronic resource] / Salah Abdel-aleem

Author
Abdel-aleem, Salah
Published
Hoboken, N.J. : John Wiley & Sons, [2009]
Copyright Date
©2009
Physical Description
1 online resource (xxi, 272 pages) : illustrations
Additional Creators
Wiley InterScience (Online service)
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Contents
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.
Subject(s)
ISBN
9780470475911
0470475919
9780470475904 (electronic bk.)
0470475900 (electronic bk.)
Note
Description based on print version record.
AVAILABLE ONLINE TO AUTHORIZED PSU USERS.
Bibliography Note
Includes bibliographical references and index.
View MARC record | catkey: 6854572