Best Practice for Clinical Monitoring
Pharmimage, January 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.
1. An Introduction to Medicine and Clinical Research
1.1 Preclinical Research
1.2 Clinical Research
1.2.1 The fundamental elements of a clinical trial
1.2.2 The different parties involved
1.2.3 Phase I
1.2.4 Phase II
1.2.5 Phase III
1.2.6 Phase IV
1.2.7 Regulations guiding clinical research
1.2.7.1 History
1.2.7.2 Declaration of Helsinki
1.2.7.3 ICH-GCP
1.2.7.4 European legislation
1.2.7.5 Food & Drug Administration
1.2.7.6 WHO
1.2.7.7 Other regulations
2. What Makes a Good Monitor?
2.1 Characteristics
2.2 Relationship with the investigator
2.3 Tools of a monitor
3. Key Documents in Clinical Trials
3.1 Protocol
3.2 Informed Consent Form
3.3 CRF
3.4 Investigator Brochure
3.5 Source documents
4. Investigator Selection
4.1 Sources
4.2 Cold call
4.3 Confidentiality
5. How to Prepare a Visit
6. Pre-Study Visit
6.1 What to check
6.2 How to check
6.3 Protocol readiness
6.4 What to do after a visit
6.4.1 Follow-up letter
6.4.2 Documentation
7. The Initiation Visit
7.1 Training
7.2 How to
7.3 What to do after an invitation visit
7.3.1 Follow-up letter
7.3.2 Documentation
8. Monitoring Visits
8.1 Source data verification
8.1.1 Electronic CRF
8.1.2 Paper CRF
8.2 Investigational medicinal product
8.2.1 Definitions
8.2.1.1 Investigational medicinal product
8.2.1.2 Medical device
8.2.1.3 Accessory
8.2.1.4 Active implantable medical device
8.1.2.5 In vitro diagnostic devices (IVD):
8.2.2 Import and export
8.2.3 IMP distribution
8.2.4 Tracking of IMP: shipments
8.2.5 Return of used/unused IMP
8.2.6 Transfer
8.2.7 Certificate of analysis
8.2.8 Investigational product
8.2.9 Labeling
8.2.10 Site inventory & patient accountability form
8.2.11 Storage conditions
8.2.12 IMP destruction
8.3 Filing
8.4 Site management
8.5 Recruitment issues
8.5.1 The right protocol
8.5.2 Selection and support of study sites
8.5.3 How to help sites?
8.5.4 Keeping track
8.6 Safety
8.6.1 Adverse event (AE)
8.6.2 Adverse drug reaction (ADR)
8.6.3 Serious adverse event (SAE)
8.6.4 Suspected unexpected serious adverse reaction (Susar)
8.6.5 Notification to EC and the authorities (European legislation)
8.7 Reporting by the monitors
8.8 What to do after a Monitoring Visit
8.8.1 Follow-up letter
9. The Close-Out Visit
9.1 What to do after the close-out visit
9.1.1 Follow-up letter
9.1.2 Documentation
10. Audits & Inspections
10.1 How to prepare
10.2 During an audit or inspection
10.3 After an audit
11. Reporting and Archiving
11.1 Communication reports
11.1.1 External
11.1.2 Internal
11.2 Safety reporting
11.2.1 CIOMS reports
11.2.2 Line listings
11.2.3 Annual safety report
11.2.4 Clinical study report
11.3 Good documentation
11.4 Archiving
Appendix 1 Answers to Self Study
Appendix 2 List of Abbreviations
Appendix 3 Index
Gerald Van Roey MPhEd is the Training Manager at the European Centre for Clinical Research Training (ECCRT). He has more than 10 years of experience as a clinical monitor and has performed more than 40 studies in areas including pharmaceutical, biotechnology and medical devices in all stages of clinical development.
Product Samples
A sample for this product is available. Please Login/Register to download this sample.
Customers who bought this item also bought
All rights reserved. © Copyright 2013 Research and Markets WWW6
Terms and Conditions Privacy Policy Publishers Employment Opportunities Site Map Link to us Webmaster Affiliate Network
