An Introduction to Clinical Trials and Clinical Trial Practice is the ICR’s flagship training course for those new to clinical research whatever the role. This highly practical course discusses all the essentials of clinical research in drug development and summarises the ethical and regulatory requirements for clinical trials.
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.
2025
Thurs 9th October
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.
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.
2025
Thurs 11th Sept
This course provides a refresher and update on Good Clinical Practice on your clinical trials, with a focus on R3 changes and how to implement them. The course will use examples of practical applications of GCP, outlining the recent major developments such as R3.
This course is NOT suitable for those who are new to clinical trials, it is designed for those who already have a foundational knowledge of GCP, are experienced with clinical trials AND want to understand the impact of the R3 updates and what they need to do. Those new to clinical research are more suited to the C01 Foundation in GCP course.
2025
Mon 8th Sept
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.
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”.
2025
Thurs 23rd October
This practical course provides delegates with an introduction to the basic project management techniques and skills that are required to fulfil the role of a clinical project manager. Learning is through a combination of lectures, discussion groups, workshops and exercises, including a workshop to demonstrate your learning of managing situations that arise in the everyday role.
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.
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?
2026
Dates to be announced
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.
2025
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.
Agency inspections may be upon you at any time during the conduct of a clinical trial – for example routine inspections during a clinical programme may be expected either of the Sponsor, a vendor or an Investigator site as part of national compliance programmes; inspections should also be expected once you have made a licence application.
Preparing for an inspection once you know one is scheduled is important – but compliance must be considered throughout the conduct of any clinical trial.
This course will aim to address the purpose of agency inspections and how they are conducted but also how ongoing compliance will ensure you are always ‘inspection ready’.
2025
Tues 7th Oct 2025
Essentials of Being a Principal Investigator is a practical, interactive training course designed for both new and experienced Principal Investigators and Sub-Investigators. Aligned with the latest ICH E6(R3) guidance, the course takes participants through the full lifecycle of a clinical trial—from feasibility to close-out—emphasizing real-world application through case-based discussions and activities. It covers key responsibilities including regulatory compliance, participant safety, data integrity, and effective oversight of site teams, investigational products, and trial processes. Participants will leave with a clear understanding of their legal and ethical obligations and the tools to demonstrate robust PI oversight.
2025
Fri 12th Sept 2025
‘C-suite’ / senior executives – are you moving into clinical development for the first time? About to embark on your first clinical trials?
The Institute of Clinical Research is delighted to present a new introduction to the regulatory, legal and financial responsibilities of the Sponsor of a clinical trial.
This 90-minute session will provide a facilitated discussion of the responsibilities of the trial Sponsor and key considerations to support the smooth conduct of your trial, ensuring participant safety, data integrity and trial output that is reliable.
2025