Design, execution, and management of medical device clinical trials / Salah Abdel-aleem.
Material type:
TextPublication details: Hoboken, N.J. : John Wiley & Sons, c2009.Description: xxi, 272 p. : ill. ; 25 cmISBN: - 9780470474266
- 9780470474266:
- Medical instruments and apparatus -- Research
- Clinical trials
- Clinical trials
- Probability & statistics
- Mathematics
- Medical specialties, branches of medicine
- Clinical & internal medicine
- Medical equipment & techniques
- Equipment and Supplies -- standards
- Clinical Trials as Topic -- methods
- Device Approval -- standards
- Evaluation Studies as Topic
- 610.284
| Item type | Current library | Call number | Copy number | Status | Date due | Barcode |
|---|---|---|---|---|---|---|
| General Lending | Carlow Campus Library General Lending | 610.284 (Browse shelf(Opens below)) | 1 | Available | 79221 |
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.
82.64