Design, execution, and management of medical device clinical trials / Salah Abdel-aleem.

Author/creator Abdel-aleem, Salah
Format Electronic
Publication InfoHoboken, N.J. : John Wiley & Sons,
Descriptionxxi, 272 p. : ill. ; 25 cm.
Supplemental ContentFull text available from Ebook Central - Academic Complete
Subjects
Medical instruments and apparatus--Research.
Clinical trials.
Equipment and Supplies--standards.
Clinical Trials as Topic--methods.
Device Approval--standards.
Evaluation Studies as Topic.

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.
Bibliography noteIncludes bibliographical references and index.
Access restrictionAvailable only to authorized users.
Technical detailsMode of access: World Wide Web
Genre/formElectronic books.
LCCN 2008049904
ISBN9780470474266 (cloth)
ISBN0470474262 (cloth)

Availability

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Electronic Resources Access Content Online ✔ Available