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

Table des matières

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.

A propos de l'auteur

Herman Pieterse, Marja G. de Jong , Peter Duijst

Détails du produit

• Auteurs: Marja de Jong, Peter Dujist, Herman Pieterse
• Collaboration: M G de Jong (Editeur), M. G. de Jong (Editeur), Peter Duijst (Editeur), Duijst Peter (Editeur), Herman Pieterse (Editeur), Pieterse Herman (Editeur)
• Edition: Taylor and Francis
• Langues: Anglais
• Format d'édition: Livre Relié
• Sortie: 30.04.1999
• EAN: 9781574910858
• ISBN: 978-1-57491-085-8
• Pages: 592
• Poids: 934 g
• Catégories: Ecole et pédagogie > Livres scolaires pour élèves; Medicine: general issues, MEDICAL / General, Medicine / Healthcare: general issues / topics