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Title: International Medical Device Clinical Investigations: A Practical Approach, Second Edition by Herman Pieterse, Marja G. De Jong, Peter Duijst, M. G. De Jong ISBN: 1-57491-085-X Publisher: CRC Press Pub. Date: 30 April, 1999 Format: Hardcover Volumes: 1 List Price(USD): $249.95

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Average Customer Rating: 4 (1 review)

Rating: 4
Summary: Excellent, practical guide
Comment: I purchased this book because I am supervising clinical trials in both Europe and the US. I found it to be a concise but athouritative guide on how to run my studies in Europe. It lays things out in a step by step manner with appropriate references where needed. This is particularly helpful because there are some significant differences in the EU verses FDA requirements. It has been of particular help to me when I've needed to educate recalcitrant investigators who have balked at GCP requirements and the volumes of paperwork required. I would recommend it for the novice as well as the expert clinical research manager. I would also recommend purchasing a copy for each of the research sites used to facillitate communications between sponsor and investigator.