Design, execution, and management of medical device clinical trials
By: Salah Abdel-aleem.
Publisher: John Wiley & Sons
Published: 2009
Place of publication: Hoboken, N.J
Language: eng
ISBN-13: 9780470474266
Subjects: Medical instruments and apparatus -- Research; Clinical trials; Equipment and Supplies -- standards; Clinical Trials as Topic -- methods; Device Approval -- standards; Evaluation Studies as Topic
Notes: Includes bibliographical references and index.
Table of contents: title: An overview of clinical study tasks and activities; title: Development of the clinical protocol case report forms, clinical standard operating procedures,  informed consent form, study regulatory binder, study research agreement, and other clinical materials; title: Qualification/selection of investigators and study monitoring visits; title: Adverse events definitions & reporting procedures; title: Statistical analysis plan (SAP) and biostastics in clinical research; title: Final clinical study report; title: Medical device regulations, combination product, study committees, and FDA-sponsor meetings; title: Design issues in medical device studies; title: Investigator initiated clinical research; title: Ethical conduct for human research; title: Glossary of clinical trial and statistical terms.