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F51 Introduction to Clinical Trials and Clinical Trial Practice


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Who should attend?

Anyone looking for a comprehensive overview of clinical research whether new to the field or currently working in a related profession. [e.g. Academic Researchers wanting to move into clinical research; CTAs or CRAs; those returning from a career break; clinical trial supplies; drug safety etc.] It covers a wide range of topics and is designed for those who need to understand the detail of clinical trials. We also run a one day course Clinical Research for Non Clinical Researchers [F9,F32 & F32] for individuals looking for a less detailed option.

Details

An Introduction to Clinical Trials and Clinical Trial Practice, the ICR’s flagship training course, is accredited by Cranfield University. This highly practical course explores the relevance of clinical research in drug development and summarises the ethical and regulatory requirements for clinical trials. It covers clinical trial methodology and summarises the principles of Good Clinical Practice.


The course gives an overview of the various aspects of clinical research and will be of interest to all members of the clinical study team. It uses a combination of lectures, tutorials and group workshops. Delegates receive a comprehensive workbook and a copy of ICH GCP guidelines. The content of the course will equip delegates to sit the ICR Certificate examination.


• Relate the relevance of clinical trials to the drug development process
• Design a simple protocol and draft appropriate case record forms
• Demonstrate the basic principles behind the statistical sections of a protocol
• Summarise the ethical and regulatory requirements that must be met before a clinical trial commences
• Describe the requirements for conducting monitoring visits
• Determine the difference between an adverse event and an adverse drug reaction
• Outline the audit process and how it fits into the quality system
• Compare the differences between drug and device trials

Prices

ICR Member – 1125 GBP (credit card 1158.75 GBP) ICR Member (Academic/Freelance) – 915 GBP (credit card 942.45 GBP) Guest – 1360 GBP (credit card 1400.80 GBP)

Contact

Jo Hall
office@icr-global.org

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