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M4 The Essentials of Trial Master File (TMF) Management | 09 February 2023 | N/A |
Online payments currently temporarily suspended. To make a payment please contact office@icr-global.org
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.
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M1 Essentials of Clinical Trial Monitoring | 15 February 2023 | Online Course |
Online payments currently temporarily suspended. To make a payment please contact office@icr-global.org
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.
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M10 Data Management for Clinical Researchers | 22 February 2023 | Online Course |
Online payments currently temporarily suspended. To make a payment please contact office@icr-global.org
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. |
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M5 Effective Project Management for Clinical Trials (3 Days ) | 28 to 02 March 2023 | N/A |
Online payments currently temporarily suspended. To make a payment please contact office@icr-global.org
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. |
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M8 Clinical Trial Administration - Beyond the Basics | 09 March 2023 | Online Course |
Online payments currently temporarily suspended. To make a payment please contact office@icr-global.org
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. |
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M3 Advanced Monitoring | 13 to 14 March 2023 | N/A |
Online payments currently temporarily suspended. To make a payment please contact office@icr-global.org
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.
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M9 Foundation in Good Clinical Practice (GCP) | 15 March 2023 | The Institute of Clinical Research Training Suite |
Online payments currently temporarily suspended. To make a payment please contact office@icr-global.org
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 |
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M6 Vendor Oversight in Clinical Trials | 16 March 2023 | Online Course |
Online payments currently temporarily suspended. To make a payment please contact office@icr-global.org
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. |
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M11 Introduction To Clinical Trials & Clinical Trials Practice | 28 to 30 March 2023 | N/A |
Online payments currently temporarily suspended. To make a payment please contact office@icr-global.org
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. |
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