International Medical Device Clinical Investigations

A Practical Approach, Second Edition
Herausgeber: Pieterse, Herman; de Jong, M G; Duijst, Peter

• Broschiertes Buch

Produktbeschreibung

The demand for clinical evidence has become an increasingly important issue in the development of medical devices. This demand is reflected not only in regulatory requirements but also by healthcare purchasers as healthcare reforms occur worldwide. Thirteen renowned experts have drawn on their practical experience in industry to provide you with this "recipe" book of how to plan, prepare, implement, and close out a medical device clinical investigation--regardless of where the trial site may be located. While many chapters reference the Medical Device Directive, the principles, philosophies, and methodologies explained are equally applicable to Active Implantable Medical Devices (AIMD) and In-vitro Diagnostic (IVD) products.

Produktdetails

• Verlag: CRC Press
• 2nd edition
• Seitenzahl: 592
• Erscheinungstermin: 23. September 2019
• Englisch
• Abmessung: 226mm x 152mm x 30mm
• Gewicht: 1116g
• ISBN-13: 9780367399771
• ISBN-10: 0367399776
• Artikelnr.: 57815187

Autorenporträt

Herman Pieterse, Marja G. de Jong , Peter Duijst

Inhaltsangabe

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.