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THIS COURSE HAS BEEN POSTPONED DUE TO NATIONAL LOCKDOWN

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.

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.

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.

Are you a clinical researcher who has to review and approve data management plans, but find yourself struggling to know what you should be looking for?  Do you have to select a Data Management vendor but don’t know how to evaluate their capabilities?  In this course we will explore data management terminology, data management plans, coding and (e)CRFs so that you can work more effectively with data management specialists.

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.

The course will give an overview of clinical pharmacology, define phase 1 studies and describe how they fit into the clinical development programme. Delegates will be guided through the regulatory and clinical aspects of phase 1 studies 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 phase 1 studies will be discussed. The course will use trainer input, exercises, and delegate interaction.

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.

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’.

ICH E8 (R1)  has been adopted since 2020. Are you ready to focus on good process design and risk management? To quote from the draft regulation: "Quality should rely on good design and its execution rather than overreliance on retrospective document checking, monitoring, auditing or inspection."

In this one day virtual course, we explore important concepts from ICH E8 (R1) such as "errors that matter", "Quality by Design" and "Critical Thinking". Topics include how to map processes to look for improvement opportunities and help people understand them better, how to assess and control risk in alignment with ICH E6 (R2), the intricacies of defining effective metrics and their use (and mis-use!), and using data to understand and improve processes. 

Join us to learn about these topics, share experiences and challenges in process improvement and measurement in clinical trials and explore realistic strategies to help your organization focus on process and risk as part of your strategy to become compliant with ICH E8 (R1). If you’re interested, contact the Institute to book for the next available date.

Medical Devices have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. There are over 300 000 types of medical devices on the EU market, examples of which include sticking plasters, contact lenses, X-ray machines, pacemakers, breast implants, software apps and hip replacements. The medical devices sector is essential to the provision of healthcare and is an important player in both the European and global economy.

Released in 2020 the updated ISO14155 standard, which 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, has been significantly revised.

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.

Please note: ISO 14155 is only applicable for Medical Devices including diagnostic/imaging devices BUT NOT In Vitro diagnostics (IVD).

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!

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.