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This course will run ONLINE VIA ZOOM

To Book: please click on the appropriate payment link below for your membership. If the link does not work, please right-click and open it in a new browser tab. If that fails please contact office@icr-global.org 

Guest - £550

ICR Member - £450

ICR Academic - £350

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).

To Book: please click on the appropriate payment link below for your membership. If the link does not work, please right-click and open it in a new browser tab.

Guest - £550

ICR Member - £450

ICR - Academic - £350

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.

To Book: please click on the appropriate payment link below for your membership. If the link does not work, please right-click and open it in a new browser tab. If that fails please contact office@icr-global.org 

Guest - £550

ICR Member - £450

ICR Academic - £350

The MHRA states that “the trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed”.

However, it is common for the MHRA to find that the TMF does not comply with regulatory requirements, is not readily available or accessible, or is “incomplete to such an extent that it cannot form the basis of inspection and therefore impedes or obstructs inspectors carrying out their duties in verifying compliance with the regulations.”

The introduction of Reg (EU) 536/2014 has had minimal impact on MHRA expectations regarding the TMF but increased globalisation and digitisation have significantly changed the way in which the TMF is now maintained and presented for inspection.

This one-day, interactive workshop guides delegates through regulatory frameworks as they apply specifically to TMF from creation through to archiving, including preparation for, and successful participation in, audits and regulatory inspection.

The presenter will use real-life case studies to illustrate common “beartraps and honey pots”  and explore best practices for TMF. Delegates will learn how best to set up, manage and maintain the TMF and gain confidence in their knowledge and ability to generate a compliant, inspection-ready, transparent, and robust TMF. 

To Book: please click on the appropriate payment link below for your membership. If the link does not work, please right-click and open it in a new browser tab. If that fails please contact office@icr-global.org 

Guest - £550

ICR Member – £450

ICR Academic - £350

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 will be ONLINE via Zoom.

To Book please click on the appropriate payment link below for your membership. If the link does not work, please right-click and open it in a new browser tab. If that fails please contact office@icr-global.org 

Guest - £550

ICR Member - £450

ICR Academic - £350

Clinical Trial Administrators are at the heart of any project team and play an essential role in the clinical trial process. This course gives an in-depth look into some of the aspects of clinical trials. It aims to give an understanding of the history and evolution of clinical research.

To Book: please click on the appropriate payment link below for your membership. If the link does not work, please right-click and open it in a new browser tab. If that fails please contact office@icr-global.org 

Guest – £1360

ICR Member – £1125

ICR Academic - £915

This practical course provides delegates with basic project management techniques that can be applied to clinical trial project management. Learning is through a combination of trainer input, discussion groups and exercises. There will be a workshop where delegates will develop a plan for tracking and managing a clinical trial case study. Delegates will receive a comprehensive course workbook.

This  Course Is ONLINE via Zoom.

To Book: please click on the appropriate payment link below for your membership. If the link does not work, please right-click and open it in a new browser tab. If that fails please contact office@icr-global.org 

Guest - £550

ICR Member - £450

ICR Academic - £350

Welcome to the GCP Refresh course! In the ever-evolving landscape of clinical research, staying updated is not just a mark of excellence but a legal imperative. This course is specifically tailored for clinical researchers who, having already been trained in Good Clinical Practice (GCP), understand the importance of continual learning. With regulations constantly evolving, especially in regions such as the EU and UK, it's crucial to stay abreast of best practices, GCP updates, and practical nuances associated with compliance. Over the duration of this course, we will delve into these updates and revisions, ensuring that you remain at the forefront of clinical research compliance and best practices. This GCP Refresh course helps to ensure you are equipped with the latest knowledge and insights to continue making impactful contributions to clinical research.

ICH GCP is applicable to clinical trials of drugs (medicinal products).  Different standards apply to drug non-interventional studies (ISPE GPP) and medical devices (ISO 14155:2020). 

To Book: please click on the appropriate payment link below for your membership. If the link does not work, please right-click and open it in a new browser tab. If that fails please contact office@icr-global.org 

Guest - £550

ICR Member - £450

ICR Academic - £350

This practical course defines the role of the clinical research monitor and explains the interaction with others in key roles as part of the clinical trial process as well as exploring the more complex aspects of clinical trial monitoring. Guidance will be given on best practices for selecting investigators, conducting monitoring visits and safety reporting. Delegates will explore strategies for dealing with common clinical trial management issues and how to adopt a preventative approach to handling monitoring issues. The course uses a blend of trainer input, exercises and delegate interaction.

To Book: please click on the appropriate payment link below for your membership. If the link does not work, please right-click and open it in a new browser tab. If that fails please contact office@icr-global.org 

Guest - £1360

ICR Member - £1125

ICR Academic - £915

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.

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.

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

The MHRA states that “the trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed”.

However, it is common for the MHRA to find that the TMF does not comply with regulatory requirements, is not readily available or accessible, or is “incomplete to such an extent that it cannot form the basis of inspection and therefore impedes or obstructs inspectors carrying out their duties in verifying compliance with the regulations.”

The introduction of Reg (EU) 536/2014 has had minimal impact on MHRA expectations regarding the TMF but increased globalisation and digitisation have significantly changed the way in which the TMF is now maintained and presented for inspection.

This one-day, interactive workshop guides delegates through regulatory frameworks as they apply specifically to TMF from creation through to archiving, including preparation for, and successful participation in, audits and regulatory inspection.

The presenter will use real-life case studies to illustrate common “beartraps and honey pots”  and explore best practices for TMF. Delegates will learn how best to set up, manage and maintain the TMF and gain confidence in their knowledge and ability to generate a compliant, inspection-ready, transparent, and robust TMF. 

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.

Welcome to the GCP Refresh course! In the ever-evolving landscape of clinical research, staying updated is not just a mark of excellence but a legal imperative. This course is specifically tailored for clinical researchers who, having already been trained in Good Clinical Practice (GCP), understand the importance of continual learning. With regulations constantly evolving, especially in regions such as the EU and UK, it's crucial to stay abreast of best practices, GCP updates, and practical nuances associated with compliance. Over the duration of this course, we will delve into these updates and revisions, ensuring that you remain at the forefront of clinical research compliance and best practices. This GCP Refresh course helps to ensure you are equipped with the latest knowledge and insights to continue making impactful contributions to clinical research.

ICH GCP is applicable to clinical trials of drugs (medicinal products).  Different standards apply to drug non-interventional studies (ISPE GPP) and medical devices (ISO 14155:2020). 

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.

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.

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

Welcome to the GCP Refresh course! In the ever-evolving landscape of clinical research, staying updated is not just a mark of excellence but a legal imperative. This course is specifically tailored for clinical researchers who, having already been trained in Good Clinical Practice (GCP), understand the importance of continual learning. With regulations constantly evolving, especially in regions such as the EU and UK, it's crucial to stay abreast of best practices, GCP updates, and practical nuances associated with compliance. Over the duration of this course, we will delve into these updates and revisions, ensuring that you remain at the forefront of clinical research compliance and best practices. This GCP Refresh course helps to ensure you are equipped with the latest knowledge and insights to continue making impactful contributions to clinical research.

ICH GCP is applicable to clinical trials of drugs (medicinal products).  Different standards apply to drug non-interventional studies (ISPE GPP) and medical devices (ISO 14155:2020). 

The MHRA states that “the trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed”.

However, it is common for the MHRA to find that the TMF does not comply with regulatory requirements, is not readily available or accessible, or is “incomplete to such an extent that it cannot form the basis of inspection and therefore impedes or obstructs inspectors carrying out their duties in verifying compliance with the regulations.”

The introduction of Reg (EU) 536/2014 has had minimal impact on MHRA expectations regarding the TMF but increased globalisation and digitisation have significantly changed the way in which the TMF is now maintained and presented for inspection.

This one-day, interactive workshop guides delegates through regulatory frameworks as they apply specifically to TMF from creation through to archiving, including preparation for, and successful participation in, audits and regulatory inspection.

The presenter will use real-life case studies to illustrate common “beartraps and honey pots”  and explore best practices for TMF. Delegates will learn how best to set up, manage and maintain the TMF and gain confidence in their knowledge and ability to generate a compliant, inspection-ready, transparent, and robust TMF. 

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.

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.

The MHRA states that “the trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed”.

However, it is common for the MHRA to find that the TMF does not comply with regulatory requirements, is not readily available or accessible, or is “incomplete to such an extent that it cannot form the basis of inspection and therefore impedes or obstructs inspectors carrying out their duties in verifying compliance with the regulations.”

The introduction of Reg (EU) 536/2014 has had minimal impact on MHRA expectations regarding the TMF but increased globalisation and digitisation have significantly changed the way in which the TMF is now maintained and presented for inspection.

This one-day, interactive workshop guides delegates through regulatory frameworks as they apply specifically to TMF from creation through to archiving, including preparation for, and successful participation in, audits and regulatory inspection.

The presenter will use real-life case studies to illustrate common “beartraps and honey pots”  and explore best practices for TMF. Delegates will learn how best to set up, manage and maintain the TMF and gain confidence in their knowledge and ability to generate a compliant, inspection-ready, transparent, and robust TMF. 

Welcome to the GCP Refresh course! In the ever-evolving landscape of clinical research, staying updated is not just a mark of excellence but a legal imperative. This course is specifically tailored for clinical researchers who, having already been trained in Good Clinical Practice (GCP), understand the importance of continual learning. With regulations constantly evolving, especially in regions such as the EU and UK, it's crucial to stay abreast of best practices, GCP updates, and practical nuances associated with compliance. Over the duration of this course, we will delve into these updates and revisions, ensuring that you remain at the forefront of clinical research compliance and best practices. This GCP Refresh course helps to ensure you are equipped with the latest knowledge and insights to continue making impactful contributions to clinical research.

ICH GCP is applicable to clinical trials of drugs (medicinal products).  Different standards apply to drug non-interventional studies (ISPE GPP) and medical devices (ISO 14155:2020).