International Medical Device Clinical Investigations: A Practical Approach, Second Edition, 2nd Edition (Paperback) book cover

International Medical Device Clinical Investigations

A Practical Approach, Second Edition, 2nd Edition

Edited by Herman Pieterse, Peter Duijst, M. G. de Jong

CRC Press

592 pages

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Paperback: 9780367399771
pub: 2019-09-23
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Hardback: 9781574910858
pub: 1999-04-30
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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.

Table of Contents

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.

About the Editors

Herman Pieterse, Marja G. de Jong , Peter Duijst

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
SCIENCE / Chemistry / General