A Practical Guide to Managing Clinical Trials

Nonfiction, Health & Well Being, Medical, Specialties, Pharmacy, Medical Science, Pharmacology, Science & Nature, Mathematics, Statistics
Cover of the book A Practical Guide to Managing Clinical Trials by JoAnn Pfeiffer, Cris Wells, CRC Press
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Author: JoAnn Pfeiffer, Cris Wells ISBN: 9781315299778
Publisher: CRC Press Publication: May 18, 2017
Imprint: CRC Press Language: English
Author: JoAnn Pfeiffer, Cris Wells
ISBN: 9781315299778
Publisher: CRC Press
Publication: May 18, 2017
Imprint: CRC Press
Language: English

A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application.

Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application.

Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

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