Clinical Research Monitoring

A European Approach

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

Readership: Clinical research monitors, clinical research associates, trial monitors, clinical research sponsors, contract research organizations (CROs), ethics committees, clinical investigators, and study nurses.
Key Features:

• Current textbooks are US (FDA)-based, but this book covers the European situation
• Provides an up-to-date review of the theoretical and practical basis of clinical research monitoring and GCP, including the latest International Council for Harmonisation (ICH) GCP revisions
• The author has more than 10 years of experience in training and education of clinical research monitors