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Clinical Research Monitoring:A European Approach /PDF

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发表于 2017-10-12 16:09 | 显示全部楼层 |阅读模式
文件基本信息(File Information) [Fomat]:PDF
[Size]:7 M
[Quality]:原版高清/矢量高清
[OCRed]:是(文字可以复制)
[Cover]:有 (Avaliable)
[Bookmark]:有(Avaliable)
[Number of Pages]:535
WARNING: DO NOT POST THIS BOOK ANYWHERE IN CASE OF BEEN FINED!




Clinical Research Monitoring:A European Approach Kindle Edition
by Ad van Dooren (Author)
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ISBN-13: 978-9813223172
ISBN-10: 9813223170
------------------------------------------------------------
    Kindle
    $140.70

  • File Size: 1463 KB
  • Print Length: 536 pages
  • Publisher: World Scientific Publishing Company (September 21, 2017)
  • Publication Date: September 21, 2017
  •   Sold by: Amazon  Digital Services  LLC
  • Language: English
  • ASIN: B0765Q276M


Clinical research monitoring is a vital aspect of Good Clinical Practice (GCP). Its principles are straightforward: they are aimed at protecting those subjects that participate in the trial, and their goal is to provide reliable data that will contribute to the safety and efficacy of the intervention under study, i.e. to support the health of future subjects. However, the practical implementation of these major goals is complicated. Various mishaps have happened in recent history, and an extensive set of international rules and regulations have emerged.This book gives a thorough survey of the ethical and legal aspects of clinical research and provides a detailed guideline for implementing these aspects into the practice of studying investigational medicinal products in humans, in the European context. It can be used as a study aid for starting monitors, a reference guide for more experienced monitors, and anyone else involved in clinical research.
<!--  -->Contents:
  • The Past
  • Medicinal Products: The Development Process
  • Clinical Trials: Design Aspects
  • The Rules and the Regs
  • The Ethical Pillars of Clinical Research
  • The Players Part I: Ethics Committee and Data Monitoring Committee
  • The Players Part II: The Sponsor and the Clinical Research Organisation
  • The Players Part III: The Investigator, the Sub-Investigator and the Clinical Research Coordinator
  • The Players Part IV: The Pharmacy and the Clinical Laboratory
  • The Players Part V: The Subject or Patient
  • Safety Assessment and Monitoring
  • The Visits
  • The Essential Documents Part I: Before Study Start
  • The Essential Documents Part II: During Trial Conduct
  • The Essential Documents Part III: After Completion or Termination of the Trial
  • Data Management
  • A Special Case: Medical Devices
  • Compliance
  • The Challenge of Monitoring
  • The Future of Clinical Trial Monitoring — Some Afterthoughts



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