Design, execution, and management of medical device clinical trials / Salah Abdel-aleem.
| Author/creator |
Abdel-aleem, Salah |
| Format | Electronic and Book |
| Publication Info | Hoboken, N.J. : John Wiley & Sons, |
| Description | xxi, 272 p. : ill. ; 25 cm. |
| Supplemental Content | Full text available from Ebook Central - Academic Complete |
| Subject(s) |
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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. |
| Bibliography note | Includes bibliographical references and index. |
| Access restriction | Available only to authorized users. |
| Technical details | Mode of access: World Wide Web |
| Genre/form | Electronic books. |
| LCCN | 2008049904 |
| ISBN | 9780470474266 (cloth) |
| ISBN | 0470474262 (cloth) |
Available Items
| Library | Location | Call Number | Status | Item Actions | |
| Electronic Resources | Access Content Online | ✔ Available |