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This course enables delegates to develop an effective strategy to plan and prepare efficiently for an audit/inspection through understanding the process and procedures.  Delegates will learn to recognise and prioritise methodologies to enable them to prepare for a successful audit/inspection and identify key stakeholders in the process. The course will explore how to reduce the anxiety of audits/inspections by having an effective strategy to be ‘audit ready’.

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. 

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.

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.

Statistics is the art and science of summarising data.  Statistics play an essential role in all stages of clinical research from design through to analysis and interpretation. 

Clinical Trials generate large volumes of data but most of us are looking for the “punch-line”;  Did the new treatment work?  Were the two groups being compared the same of different?  We rely on statistics to help us design the most appropriate trial to answer our questions, to determine the required sample size and to interpret the results.  A poorly designed study wastes time, resources and puts patients at unnecessary risk.  A solid understanding of statistical principals is important for all team members, not just the team statistician; however for many of us statistics is nearly a foreign language. 

This course is aimed at non-statisticians who work in clinical research and provides an introduction to the statistical methods used for the design, conduct and analysis of clinical trials.  The course emphasises the application of statistical concepts to clinical research; aiming to demystify the subject and equipping delegates with the knowledge to read, understand, interpret and communicate data & statistics. 

This is an introductory course and no significant mathematical knowledge is required.

Delegates should bring a laptop and calculator to the course.

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.