Module manager: Sue Bell
Email: s.e.bell@leeds.ac.uk
Taught: Semester 2 (Jan to Jun) View Timetable
Year running 2025/26
See programme entry requirements
This module is not approved as an Elective
Clinical trials are a key method used by researchers to determine if new treatments or interventions are beneficial to patients or service users. This module will provide you with an understanding of the key concepts of clinical trials research, enabling you to interpret and assess clinical research you encounter within your field and the ability to have informed conversations with collaborators when designing new research design and conduct your own research. During the module you will be supported by tutors who have significant experience in designing and conducting clinical trials research including those with specific expertise in trial and data management, statistics, clinical trials methodology, funding applications and patient and public involvement in research.
Through lectures and group activities, you will gain a strong foundation in clinical trials that you can use to understand existing research and allow you to provide informed contributions when developing or conducting new research. You will gain insight into the national context for clinical trials including UK infrastructure, how a clinical trials research unit operates and the need for legislation. You will be introduced to the different phases of clinical trials research, associated research designs and statistical considerations. You will learn about the grant application development and funding process and gain knowledge of how clinical trials are conducted in practice. You will also understand the impact of ethical considerations, the importance of good clinical practice during trial delivery and how results of clinical research are disseminated.
On successful completion of the module and associated assessment, you will have demonstrated the following learning outcomes which will provide you with work ready and academic skills:
1. Apply effective communication skills. For example, this will be realised as you clearly and accurately summarise the key points of a funding application to colleagues and engage in group discussion to understand the views of others before reaching a consensus regarding a funding decision.
This maps onto the Leeds Skill Matrix: Work ready skills: communication. Academic skills: presentation skills.
2. Demonstrate critical thinking. For example, this will be realised as you interrogate a standard operating procedure to gather information, analyse the content and use reasoning and judgement to determine whether it is accurate and relevant.
This maps onto the Leeds Skill Matrix: Work ready skills: critical thinking.
3. Applying research skills. For example, this will be realised as you access and investigate evidence to propose a reasonable solution to an existing clinical issue and design and plan the conduct of a future clinical trial to address the identified challenge.
This maps onto the Leeds Skill Matrix: Academic skills: information searching and critical thinking; Enterprise skills: spotting opportunities.
4. Demonstrate academic writing. For example, this will be realised as you write effectively to succinctly and articulately summarise the design and planned conduct of a clinical trial in text which is relevant to an academic and to a lay audience and adheres to the academic convention required.
This maps onto the Leeds Skill Matrix: Academic skills: academic writing.
On successful completion of the module and associated assessment, you will have demonstrated the following learning outcomes relevant to the subject:
1. Discuss the role of a clinical trials research unit and the different disciplines and expertise they provide during trial design, conduct and evaluation;
2. Implement advanced knowledge of different research designs and associated objectives for the different phases of clinical trials research;
3. Recognise the different elements involved in the set-up and conduct of a clinical trial including ethical considerations, the importance of adherence to good clinical practice and the writing of standard operating procedures;
4. Demonstrate advanced knowledge of the requirements of a successful funding application including the importance of the scientific and plain English summaries;
5. Critically appraise the design and planned conduct of clinical trials research.
1. UK infrastructure supporting clinical trials research including the structure of a clinical trials research unit
2. Legislation governing clinical trials
3. Phases of clinical trials
4. Clinical trial design
5. Statistics in clinical trials
6. Funding bodies and grant applications for clinical trials research
7. Good clinical practice
8. Setting up and running a clinical trial
9. Patient and public involvement in clinical trials
10. Dissemination of clinical trial results
| Delivery type | Number | Length hours | Student hours |
|---|---|---|---|
| Lectures | 4 | 2 | 8 |
| Seminar | 10 | 2 | 20 |
| Private study hours | 122 | ||
| Total Contact hours | 28 | ||
| Total hours (100hr per 10 credits) | 150 | ||
Independent online learning will supplement the formal classes and will make use of a portfolio of materials. Students will also be expected to work in their own time, researching taught and online course work, building up their knowledge using the guidance provided by formal taught and online components of the module.
Seminars including small group work with tutor support will take place throughout the module, providing you with regular opportunities for formative feedback on the topics being covered. For example, on the final day of the module you will participate in a mock funding panel meeting. This will involve reading some real funding applications, critically appraising the proposals using the knowledge you have gained during the module and participating in a group discussion to determine whether or not you would fund the research.
In addition, during a seminar you will complete a single one-off quiz which focuses on assessing your knowledge of ethics and good clinical practice in clinical trials. You will receive immediate formative feedback on your responses (total duration 1 hour).
| Assessment type | Notes | % of formal assessment |
|---|---|---|
| Written Work | Short summary of a grant application | 75 |
| Critique | Critical appraisal of a SOP (Standard Operating Proceedure) | 25 |
| Coursework | Formative assessment – Good Clinical Practice quiz | 0 |
| Role-play | Formative assessment – Mock grant review panel | 0 |
| Total percentage (Assessment Coursework) | 100 | |
Compensation is not permitted across summative components (e.g. a pass mark in all components of the assessment is required to pass the module). Resits will be in the same format as the original failed piece of coursework. Module marks will be capped at 50% on successful resit of any failed assessment in the module.
The reading list is available from the Library website
Last updated: 30/04/2025
Errors, omissions, failed links etc should be notified to the Catalogue Team