International Medical Device Clinical Investigations

A Practical Approach, Second Edition

Herman Pieterse, Peter Duijst, M. G. de Jong (Herausgeber)

Buch | Hardcover

592 Seiten

1999 | 2nd edition
Crc Press Inc (Verlag)
978-1-57491-085-8 (ISBN)

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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.

Herman Pieterse, Marja G. de Jong , Peter Duijst

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.

Erscheint lt. Verlag	30.4.1999
Verlagsort	Bosa Roca
Sprache	englisch
Maße	152 x 229 mm
Gewicht	934 g
Themenwelt	Medizin / Pharmazie ► Allgemeines / Lexika
ISBN-10	1-57491-085-X / 157491085X
ISBN-13	978-1-57491-085-8 / 9781574910858
Zustand	Neuware