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- 2008049904 contributor B11131263.
- 2008049904 created "c2009.".
- 2008049904 date "2009".
- 2008049904 date "c2009.".
- 2008049904 dateCopyrighted "c2009.".
- 2008049904 description "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.".
- 2008049904 description "Includes bibliographical references and index.".
- 2008049904 extent "xxi, 272 p. :".
- 2008049904 identifier "0470474262 (cloth)".
- 2008049904 identifier "9780470474266 (cloth)".
- 2008049904 issued "2009".
- 2008049904 issued "c2009.".
- 2008049904 language "eng".
- 2008049904 publisher "Hoboken, N.J. : John Wiley & Sons,".
- 2008049904 subject "2009 J-792".
- 2008049904 subject "610.28/4 22".
- 2008049904 subject "Clinical Trials as Topic methods.".
- 2008049904 subject "Clinical trials.".
- 2008049904 subject "Device Approval standards.".
- 2008049904 subject "Equipment and Supplies standards.".
- 2008049904 subject "Evaluation Studies as Topic.".
- 2008049904 subject "Medical instruments and apparatus Research.".
- 2008049904 subject "R856.4 .A23 2009".
- 2008049904 subject "W 26 A135d 2009".
- 2008049904 tableOfContents "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.".
- 2008049904 title "Design, execution, and management of medical device clinical trials / Salah Abdel-aleem.".
- 2008049904 type "text".