2nd Edition
International Medical Device Clinical Investigations A Practical Approach, Second Edition
592 Pages
by
CRC Press
592 Pages
by
CRC Press
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,... Read more
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.
Biography
Herman Pieterse, Marja G. de Jong , Peter Duijst
