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. In this blog post, you will be able to download free PDF e-book copy of Clinical Research Monitoring PDF.
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.
Table of Contents
Below is the complete table of contents presented in Clinical Research Monitoring PDF:
Chapter 1: The Past
Chapter 2: Medicinal Products: The Development Process
Chapter 3: Clinical Trials: Design Aspects
Chapter 4: The Rules and the Regs
Chapter 5: The Ethical Pillars of Clinical Research
Chapter 6: The Players Part I: Ethics Committee and Data Monitoring Committee
Chapter 7: The Players Part II: The Sponsor and the Clinical Research Organisation
Chapter 8: The Players Part III: The Investigator, the Sub-Investigator and the Clinical Research Coordinator
Chapter 9: The Players Part IV: The Pharmacy and the Clinical Laboratory
Chapter 10: The Players Part V: The Subject or Patient
Chapter 11: Safety Assessment and Monitoring
Chapter 12: The Visits
Chapter 13: The Essential Documents Part I: Before Study Start
Chapter 14: The Essential Documents
Chapter 15: The Essential Documents
Chapter 16: Data Management
Chapter 17: A Special Case: Medical Devices
Chapter 18: Compliance
Chapter 19: The Challenge of Monitoring
Chapter 20: The Future of Clinical Trial Monitoring — Some Afterthoughts
Here are the technical specifications of Clinical Research Monitoring PDF:
Book Name: Clinical Research Monitoring: A European Approach
Edition: 1st Edition | | ISBN : 9813223170
Author Name: AD VAN DOOREN;
Format / Pages: PDF – 536 Pages
Clinical Research Monitoring PDF Free Download
Here you will be able to download Clinical Research Monitoring: A European Approach PDF by using our direct download links that have been mentioned at the end of this article. This is a genuine PDF e-book file. We hope that you find this book useful in your studies. 🙂
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