Course | Date | Venue | Description | |
---|---|---|---|---|
M17 Clinical Investigations for Medical Devices - Foundation | 05 June 2023 | CIM Moor Hall Conference Centre, The Moor, Cookham SL6 9QH |
In this one day course we explore clinical investigations for medical devices. We will review the latest legislation and its impact on determining whether a clinical trial is required. Our experienced trainer will guide you through the key stages in designing
and executing your clinical investigation. Through practical exercises delegates will tackle common challenges and develop strategies to overcome them. |
more info + book |
M13 Statistics for Non-Statisticians | 07 June 2023 | CIM Moor Hall Conference Centre, The Moor, Cookham SL6 9QH |
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. |
more info + book |
M20 Advanced Monitoring | 20 to 21 June 2023 | CIM Moor Hall Conference Centre, The Moor, Cookham SL6 9QH | In this highly practical course we look at the root cause of typical inspection findings and work with delegates to develop personal corrective and preventative action plans. Through case studies, we will address challenging monitoring situations and develop strategies for investigator selection, fraud detection, improving patient recruitment and for motivating investigator sites. Delegates will explore how both technology and legislation will impact the role of the monitor. We also discuss key principles in project planning and execution to allow experienced CRAs to begin to develop the skills required for a Lead CRA or Clinical Trial Manager role. Delegates will learn how to apply project planning principles to monitoring to improve efficiency. It is recommended that delegates have a minimum of two years of monitoring experience. |
more info + book |
M19 Effective Project Management for Clinical Trials (3 Days ) | 27 to 29 June 2023 | CIM Moor Hall Conference Centre, The Moor, Cookham SL6 9QH | 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. | more info + book |
M22 Foundation in Good Clinical Practice (GCP) | 05 July 2023 | N/A | 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 |
more info + book |
M23 Clinical Trial Administration - Beyond the Basics | 12 July 2023 | Online Course | more info + book | |
M24 Introduction To Clinical Trials & Clinical Trials Practice | 18 to 20 July 2023 | CIM Moor Hall Conference Centre, The Moor, Cookham SL6 9QH | 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. | more info + book |
M25 Introduction To Clinical Trials & Clinical Trials Practice | 05 to 07 September 2023 | CIM Moor Hall Conference Centre, The Moor, Cookham SL6 9QH | 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. | more info + book |
M26 Data Management for Clinical Researchers | 13 September 2023 | N/A | 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. |
more info + book |
M18 The Essentials of Trial Master File (TMF) Management | 14 September 2023 | CIM Moor Hall Conference Centre, The Moor, Cookham SL6 9QH | The MHRA GCP Inspectorate has updated their definition of critical to include, ‘where provision of the Trial Master File (TMF) does not comply with Regulation 31A 1-3, as the TMF is not readily available or accessible, or the TMF 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.’ This follows numerous issues with inspector access to TMFs and incomplete TMFs. The TMF provides the basis for inspection by the competent authority (2005/28/EC). The UK Clinical Trial Regulations (2004/1031, Regulation 31A) require that the sponsor must keep a TMF and it must be readily available and shall at all times contain the essential documents relating to the trial. This course demonstrates how to set up, maintain and manage a document system that meets the required regulatory standards. It gives an overview of the specific requirements in document management and explains the need for an audit trail of documents that is transparent and robust. Delegates are guided through the process of archiving documentation and the preparation for, and participating successfully in, a quality assurance audit or regulatory inspection. |
more info + book |
M27 GCP for Experts | 20 September 2023 | Online Course |
THIS COURSE DATE IS TO BE CONFIRMED Please email office@icr-global.com for enquiries 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. |
more info + book |
M28 ISO-14155:2011 - Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practice | 21 September 2023 | Online Course |
This course will run ONLINE VIA ZOOM
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). |
more info + book |
M29 Effective Project Management for Clinical Trials (3 Days ) | 03 to 05 October 2023 | CIM Moor Hall Conference Centre, The Moor, Cookham SL6 9QH | 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. | more info + book |
M32 Essentials of Clinical Trial Monitoring | 08 November 2023 | CIM Moor Hall Conference Centre, The Moor, Cookham SL6 9QH | 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. | more info + book |
M33 Advanced Monitoring | 14 to 15 November 2023 | CIM Moor Hall Conference Centre, The Moor, Cookham SL6 9QH | In this highly practical course we look at the root cause of typical inspection findings and work with delegates to develop personal corrective and preventative action plans. Through case studies, we will address challenging monitoring situations and develop strategies for investigator selection, fraud detection, improving patient recruitment and for motivating investigator sites. Delegates will explore how both technology and legislation will impact the role of the monitor. We also discuss key principles in project planning and execution to allow experienced CRAs to begin to develop the skills required for a Lead CRA or Clinical Trial Manager role. Delegates will learn how to apply project planning principles to monitoring to improve efficiency. It is recommended that delegates have a minimum of two years of monitoring experience. |
more info + book |
M34 Vendor Oversight in Clinical Trials | 21 November 2023 | Online Course |
DATE TBC Vendor Oversight is currently a hot topic as sponsors and vendors aim to get to grips with what is really required. You don’t want to outsource and then expend multiple resources to manage and oversee your trial. As a vendor you want to get on with the
outsourced clinical trial in the most effective way feasible without micromanagement from your sponsor company. What is required to compliantly and efficiently implement vendor oversight? What are the risks and challenges of not getting this right from the
beginning? This course will aim to work through some of these challenging topics with time given to work through specific scenarios from the attendees. |
more info + book |
M35 Clinical Trial Administration - Beyond the Basics | 22 November 2023 | Online Course | more info + book | |
M36 The Essentials of Trial Master File (TMF) Management | 30 November 2023 | CIM Moor Hall Conference Centre, The Moor, Cookham SL6 9QH | The MHRA GCP Inspectorate has updated their definition of critical to include, ‘where provision of the Trial Master File (TMF) does not comply with Regulation 31A 1-3, as the TMF is not readily available or accessible, or the TMF 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.’ This follows numerous issues with inspector access to TMFs and incomplete TMFs. The TMF provides the basis for inspection by the competent authority (2005/28/EC). The UK Clinical Trial Regulations (2004/1031, Regulation 31A) require that the sponsor must keep a TMF and it must be readily available and shall at all times contain the essential documents relating to the trial. This course demonstrates how to set up, maintain and manage a document system that meets the required regulatory standards. It gives an overview of the specific requirements in document management and explains the need for an audit trail of documents that is transparent and robust. Delegates are guided through the process of archiving documentation and the preparation for, and participating successfully in, a quality assurance audit or regulatory inspection. |
more info + book |
M37 Introduction To Clinical Trials & Clinical Trials Practice | 05 to 07 December 2023 | CIM Moor Hall Conference Centre, The Moor, Cookham SL6 9QH | 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. | more info + book |
M38 Foundation in Good Clinical Practice (GCP) | 13 December 2023 | Online 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 |
more info + book |