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UKTraining

F36 Non Interventional Clinical Trials


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Who should attend?

Any individuals looking for an overview of non-interventional studies and how they differ from classic randomised clinical trials.

Details

The delegates will be guided through the regulatory and clinical aspects of non-interventional clinical trials and identify the key safety and ethical issues that need to be managed.  The issues relating to design, set-up, choosing subjects and conduct of non-interventional studies will be discussed. The training day would combine presentations and exercises to provide an interactive and practical learning experience


By the end of this course, you will be able to…

• Distinguish between NIS and Interventional Studies and describe the key differences
• Utilise the Eudralex and MHRA decision trees
• Define Low Interventional Studies
• Outline the key features of Observational/Registry/PAES/PASS Studies
• Identify the key steps and documents required to set up NIS in Europe
• Ask critical questions to assist in the design of an NIS
• Describe common challenges with NIS and identify possible solutions/mitigating actions

Prices

One Day Course ICR Member - 450GBP (credit card 463.50GBP) ICR Member (Academic/Freelance) - 350GBP (credit card 360.50GBP) Guest - 550GBP (credit card 566.50GBP)

Contact

Jo Hall
office@icr-global.org

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