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Best Practice for Clinical Monitoring
Pharmimage, Jan 2011, Pages: 144
The Best Practice series takes Good Clinical Practice to the next level and makes it better!
As a bridge between SOPs and the monitoring reality, the book is interesting for clinical research professionals such as Clinical Monitors, Clinical Investigators and Auditors. The book provides a practical approach to the day-to-day responsibilities of a Clinical Monitor and contains a number of practical examples that guide the reader on how to handle difficult studies and how these could be managed. The author is responsible for the training of approximately 200 staff in a European CRO. In his more than 10 years experience he has been able to collect relevant information about the most common pitfalls in the day-to-day activities of monitors.
Attractive, affordable and easy to use, this book provides a sign-posted map for beginners and experienced Clinical Monitors through the maze of clinical research. Written from a wealth of personal experience, this book provides a real-life insight into clinical studies and the specific role of the Clinical Monitor.
Published in 2011 in full color, with 144 pages, this book covers the complete life cycle of a clinical trial. You will find practical tips and best practices for each phase of the clinical study, from selecting the right investigator to preparing for, and surviving, an inspection.
Through real-life situations, linked to regulatory and industry standards, this book covers the complete life cycle of a clinical trial. You will find practical tips and best practices for each phase of the clinical study, from selecting the right investigator to preparing for, and surviving an inspection. With integrated examples of actual documents you will come across in the field and valuable lessons learned, this book will enable you to perform your job as Clinical Monitor to the very best of your ability and according to today's standards.
You will discover:
- How to fit into the activities of the world of clinical research
- The latest regulations and guidelines, what they mean for you, how to follow them and where to find further information
- How to prepare and perform site visits and interact with site personnel
- What Essential Documents are and how they should be handled
- How to document your work correctly according to international standards
- Foresee and avoid potential pitfalls in your study
- What you need to progress in your chosen career
- And more…
Published in 2011 in full color, with 144 pages, this book covers the complete life cycle of a clinical trial. You will find practical tips and best practices for each phase of the clinical study, from selecting the right investigator to preparing for, and surviving, an inspection.
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