John Wiley & Sons The Fundamentals of Clinical Research Cover This book provides insight into the practical application of good clinical practice (GCP) fundamenta.. Product #: 978-1-118-94959-7 Regular price: $151.40 $151.40 Auf Lager

The Fundamentals of Clinical Research

A Universal Guide for the Implementation of Good Clinical Practice

Dubinsky, P. Michael / Henry, Karen A.

Cover

1. Auflage Dezember 2021
544 Seiten, Hardcover
Wiley & Sons Ltd

ISBN: 978-1-118-94959-7
John Wiley & Sons

Kurzbeschreibung

This book provides insight into the practical application of good clinical practice (GCP) fundamentals. It applies the regulatory, scientific, administrative, business, and ethical considerations of clinical research trials within GCP framework. The book offers a universal resource on how to implement clinical research to meet the research, regulatory, and ethical objectives in a manner in a quality manner conforming to GCP. By including the quality element, the authors further the quality system / quality by design mindset that has emerged in the clinical research community. Each chapter concludes with a quiz containing pertinent questions and answers so that the reader can self-check learning and comprehension. For each topic within a chapter, the authors highlight key points underpinning GCP expectation or implementation.

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This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations.
* Describes the design of quality into the clinical trial planning
* Includes end-of-chapter questions and answers to check learning and comprehension
* Has a separate instructor's guide available for registered adopters