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Providing the information necessary for the performance of clinical trials, from their initiation to their termination and reporting, including forms and excerpts from existing regulations, this book covers regulations in 34 countries in Europe, Australasia, Africa, North America, and South America.
It interprets processes and relates them to the ICH GCP guidelines. The chapters are similar in their format, but differ in their content, reflecting the differing requirements throughout the world. The chapter authors are locally based experts and include government authorities, national Ethics Committee chairpersons, company regulatory affairs professionals, and independent consultants.