Overview

The Introduction to Clinical Trials course offers a comprehensive and practical introduction to the design and conduct of randomised clinical trials (RCTs). Through a combination of flexible online learning and interactive tutor-led sessions, students will gain an understanding of the key principles that underpin high-quality clinical research and the evaluation of healthcare interventions. It is ideal for healthcare professionals, researchers, trial staff, statisticians, clinicians, and anyone involved in the planning, delivery, analysis, or review of clinical research. 

 

The course is divided into two modules: 

 

Module 1: Trial Design 

  • Why clinical trials are needed 

  • Key principles of trial design 

  • Randomisation and control groups 

  • Minimising bias and improving trial quality 

  • Choosing appropriate outcomes and endpoints 

 

Module 2: Trial Conduct 

  • Protocol development 

  • Trial oversight and management 

  • Participant recruitment and retention 

  • Data collection and monitoring 

  • Analysis and interpretation of trial findings 

  • Reporting and dissemination of results 

 

The course focuses primarily on large, multicentre randomised clinical trials, including both drug trials and trials of complex interventions. It does not cover non-randomised studies, observational research designs, or trials evaluating diagnostic tests. 

 

“ I found the course suitable both for novices as well as more experienced managers; it weaves together the essentials of trial management from A-Z, giving a comprehensive overview of all aspects of running a trial whilst supplemented by focussed links to more in-depth information on all subject areas.  There is no doubt that completing this course gave me the additional insight and added confidence to secure a post within a trial management team.  I highly recommend it! “ 

 Live Session Schedule Nov 2026

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Outcomes

By the end of the course, students should: 

 

Module 1 "Trial Design" 

  • Understand when and why randomised controlled trials (RCTs) are the most appropriate study design. 

  • Evaluate methods used to minimise bias in the design and conduct of randomised clinical trials. 

  • Describe different randomised trial designs and identify when they are most appropriately used. 

  • Understand the key information required to determine an appropriate trial sample size. 

  • Contribute effectively to the design of a randomised clinical trial. 

  • Recognise the role of complementary methodologies, including qualitative research and health economic evaluation. 

  • Appreciate the importance of meaningful Patient and Public Involvement and Engagement (PPIE) throughout the clinical trial lifecycle. 

 

Module 2 "Trial Conduct" 

  • Understand the regulatory, ethical, and governance approvals required for clinical trials. 

  • Describe the purpose and key components of a clinical trial protocol and associated trial documentation. 

  • Identify the practical considerations involved in setting up and delivering multicentre clinical trials. 

  • Understand safety reporting requirements, including those specific to clinical trials involving investigational medicinal products. 

  • Explain the principles of risk assessment, data management, monitoring, and quality assurance in clinical trials. 

  • Understand how trial results are analysed, interpreted, and reported to inform clinical practice and future research. 

 

Is this course for you?

This course is suitable for anyone seeking an introduction to the design and conduct of randomised clinical trials. It is particularly relevant for: 

 

  • Researchers planning or contributing to clinical trials 

  • Healthcare professionals involved in clinical research 

  • Trial managers, research nurses, trial coordinators and data managers 

  • Statisticians and methodologists new to clinical trials 

  • Academic staff and postgraduate students interested in trial methodology 

  • Members of research teams responsible for delivering, analysing, reporting or reviewing clinical trials 

 

The course is delivered entirely online through Microsoft Teams and runs over four weeks. Students will have access to a range of learning materials, including: 

 

  • 21 pre-recorded lectures 

  • 12 live online tutor-led sessions (1 hour each) 

  • Supporting resources and self-directed learning activities 

 

Course materials are available before the start date and remain accessible throughout the course, allowing students to learn at their own pace and fit their studies around existing professional and personal commitments. 

 

Live sessions are scheduled throughout each module and provide opportunities to discuss key concepts, ask questions, reflect on learning activities, and engage with tutors and fellow students. While attendance is not mandatory, students are strongly encouraged to attend as many sessions as possible to maximise their learning experience. Session dates will be provided in advance. 

 

The course combines the flexibility of self-paced online learning with interactive tutor-led teaching. As the programme is content-rich and practice-focused, students should plan sufficient time to engage with the learning materials and activities throughout the four-week period. 


 
 

 Course tutors

All sessions on the course are delivered by experienced trialists and professional staff from Nottingham Clinical Trials Unit (NCTU). Tutors bring extensive experience in the design, conduct, analysis, and reporting of clinical trials across a wide range of disease areas and healthcare settings. This ensures that course content is grounded in real-world practice and reflects the challenges and opportunities encountered when delivering high-quality clinical research. Students will benefit from insights drawn from NCTU's involvement in national and international multicentre trials, gaining practical knowledge that can be applied directly to their own research and professional roles. 
 

 Cost

Early Bird rate: If you book on or before 2nd October, you will be entitled to the Early Bird rate, cost as follows:  

£180 - Person residing in a low and middle income country, as defined by DAC list, at the time of registration.  

£290 – University of Nottingham, School of Medicine student or staff member  

£330 – University of Nottingham student or staff member (NOT School of Medicine)  

£330 – NHS employee  

£360 – anyone who does not fall into any of the categories above  

  
Standard rate: Any bookings made on or after 3rd October will be charged as follows:  

£227 - Person residing in a low and middle income country, as defined by DAC list, at the time of registration 

£360 – University of Nottingham, School of Medicine student or staff member  

£410 – University of Nottingham student or staff member (NOT School of Medicine)  

£410 – NHS employee 

£450 – anyone who does not fall into any of the categories above  

 

 

What does the course include?

The course is delivered entirely through Microsoft Teams, providing students with easy access to all learning materials and live teaching sessions in one place. Prior to the course start date, delegates will receive detailed guidance and joining instructions to help them access the platform and make the most of the online learning environment. 
 

 How do I book?

Please visit the booking page.  Upon registration you will receive an automated response confirming your place. The course administrator will be in touch via email a few weeks before the course start date, detailing the course programme and further details e.g. how to find the venue etc.  Please direct any queries to ctu@nottingham.ac.uk 
 

Terms and conditions

In the event that you need to cancel your booking we ask that you give as much notice as possible.  Students cancelling more than two weeks before the start of the course will be eligible for a full refund, after that time you will be charged the full course fee.  In the unlikely event that the short course has to be cancelled, our liability is limited to course fees only.  If you need to cancel, please email your request to ctu@nottingham.ac.uk 

For further information please contact ctu@nottingham.ac.uk or 0115 8231600