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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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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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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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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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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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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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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.