International Medical Device Clinical Investigations - A Practical Approach, Second Edition

Sommario

Clinical Regulatory Environment. Design in Clinical Trials. Managing Multi-Dimensional Clinical Projects. Device Classification and Risk Assessment. Clinical Strategy Development. Clinical Trial Project Plan. Quality Assurance for Good Clinical Practices. Protocol Development. The Clinical Investigator's Brochure. Budgeting. The Investigator Contract. Informed Consent. The Design of Case Report Forms. Labeling and Instructions for Use. Ethics Committee Approval. Insurance and Liability. Selection and Training of Clinical Trial Monitors. How to Prepare the Clinic. Monitoring Visits. In-house Monitoring by the Clinic. Data Management. Filing and Archiving. Adverse Event Processing During Clinical Trials. Statistics. Reporting of Data. How to Handle Suspected Fraud.

Info autore

Herman Pieterse, Marja G. de Jong , Peter Duijst

Dettagli sul prodotto

• Autori: Marja de Jong, Peter Dujist, Herman Pieterse
• Con la collaborazione di: M G de Jong (Editore), M. G. de Jong (Editore), Peter Duijst (Editore), Duijst Peter (Editore), Herman Pieterse (Editore), Pieterse Herman (Editore)
• Editore: Taylor and Francis
• Lingue: Inglese
• Formato: Copertina rigida
• Pubblicazione: 30.04.1999
• EAN: 9781574910858
• ISBN: 978-1-57491-085-8
• Pagine: 592
• Peso: 934 g
• Categorie: Libri scolastici > Libri scolastici per istituti a indirizzo generale; Medicine: general issues, MEDICAL / General, Medicine / Healthcare: general issues / topics