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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 full-day course provides an in-depth look at the regulatory systems currently in operation in the US and EU and their impact on the conduct of clinical research. The course explains in detail the practical applications of GCP such as risk management, and outlines recent and planned major developments in GCP. It also explores the impact of EU data protection laws on clinical research and provides insight into regulatory inspection approaches as well as “hot topics”.

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.