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Are you working with clinical researchers but not actually engaged in clinical research yourself?

 Do you find yourself struggling to understand the myriad of acronyms that people use?

Do you wonder why your colleagues seem to obsess over documentation and get stressed over "Self Addressed Envelopes" [SAEs]?

Then join us for this double espresso style course. We'll bring the coffee!

ICH E6 (R2) has emphasized the importance of risk management in relation to ensuring subject safety and rights as well as data integrity in clinical trials. Understanding, oversight and improving clinical trial processes, is a fundamental way of managing these risks. this course demonstrates ways to map processes, how to measure them and to understand how they might fail. It provides a tool kit for root cause analysis and provides approaches to improve processes so as to minimize risk. Throughout, examples are used from clinical trials and participants are encouraged to practise the skills they learn. 

This course provides an in-depth look at the regulatory systems currently in operation in the EU and their impact, together with UK legislation, on the conduct of clinical research. Starting with a refresher on the history of medicinal product regulations and the need for ethics, the course explains in more detail the practical applications of GCP and outlines recent major developments in GCP. It also explores the impact of EU data protection laws on clinical research and summarises other current issues that affect clinical trials.

Delegates will receive a complimentary copy of the ICH GCP guidelines and a workbook.

Approximately 1.5 million different medical devices are available globally; with thousands of new and innovative medical devices being introduced to the market every year. While there is legislation at the national and regional level ISO 14155 provides a global standard for clinical investigations on human subjects.

In this course we explore ISO-14155 in detail.  ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes. 

This International Standard specifies general requirements intended to:

• Protect the rights, safety and well-being of human subjects

• Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results

• Define the responsibilities of the sponsor and principal investigator

• Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

 ISO 14155:2011 does not apply to in vitro diagnostic medical devices.

Do you want to work SMARTER not HARDER?  This course is focused on the needs of a clinical researcher and is a very practical course with exercises and methods to build and develop the core soft skills to allow you to work more efficiently and increase your productivity.

Oftentimes issues arise due to communication breakdown.  We look at how information should flow within project teams and examine when different types of communication are most effective.

We all work to tight deadlines, but do you find yourself wondering where your day has gone?  Our trainer will help you examine your working practices to enable you to set goals, prioritise activities and develop an effective working plan, while keeping your eyes open for those time thieves.