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Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections 1st Edition

3.0 out of 5 stars 2 customer reviews
ISBN-13: 000-0470248858
ISBN-10: 0470248858
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Editorial Reviews

Review

"To help the reader, in addition to the detailed and meticulous discussions in the book's five chapters, appendices provide ready access to fundamental literature . . .Clinical Trials Audit Preparation is recommended to readers, and receives the JCS Library Award." (Journal for Clinical Studies, 1 November 2010)

"Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections" is a comprehensive manual for avoiding inspections, preparing for inspections, and being inspected. It is also a useful guide for inspectors." (Journal of Clinical Research Best Practices, 6 June 2011)

About the Author

VERA MIHAJLOVIC-MADZAREVIC has more than twenty years of experience in scientific and clinical research in the academia and industry. She is the Director of Global Research Pharma Canada. She conducts Good Clinical Practice (GCP) audits for the pharmaceutical, biotech, and medical device industries worldwide in compliance with FDA, Health Canada, and other regulations. She also trains clinical and scientific personnel in GCP and clinical research, leading the Training and Professional Development Programs at the Clinical Research Institute of America (criamerica.com) and the Academy of Applied Pharmaceutical Sciences.
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Product Details

  • Hardcover: 246 pages
  • Publisher: Wiley; 1 edition (June 1, 2010)
  • Language: English
  • ISBN-10: 0470248858
  • ISBN-13: 978-0470248850
  • Product Dimensions: 6.4 x 0.8 x 9.6 inches
  • Shipping Weight: 1.2 pounds (View shipping rates and policies)
  • Average Customer Review: 3.0 out of 5 stars  See all reviews (2 customer reviews)
  • Amazon Best Sellers Rank: #1,506,634 in Books (See Top 100 in Books)

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Top Customer Reviews

Format: Hardcover Verified Purchase
El contenido que ofrece el libro constituye una excelente guía de estudio y formación para quienes se encuentran inmersos en el mundo de la investigación clínica, comités de bioética y aspectos regulatorios (auditoría)
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Format: Kindle Edition Verified Purchase
Content seems fine and as expected but without page numbers the kindle edition just didn't fulfill the requirements for the class.
No fault of the book, had I done research ahead of time I would have known this kindle book did not include page numbers.

Gave only 1 star because the focus of this book would be for college and not having page numbers in a course study book is pretty inconvenient.
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