Course Catalogue

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This course explores the critical functions and responsibilities of an academic Clinical Trials Unit (CTU) in a UK setting. It will cover aspects of designing, implementing, managing, and evaluating clinical trials, including trial data management. Students will gain a comprehensive understanding of CTUs' contributions to advancing evidence-based medicine and will have the knowledge needed to effectively collaborate with a CTU on clinical trials.

Beginning of second semester (2a), running for 6 weeks and delivered live in-person.

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1. Individual written report (2000 words, 60%) [ILO1-4].

2. Group project (includes group presentation for 15 minutes at 20%, and individual written summary at 20%) [ILO1-3].

Reassessments are normally available for all courses, except those which contribute to the Honours classification. Where, exceptionally, reassessment on Honours courses is required to satisfy professional/accreditation requirements, only the overall course grade achieved at the first attempt will contribute to the Honours classification. For non-Honours courses, students are offered reassessment in all or any of the components of assessment if the satisfactory (threshold) grade for the overall course is not achieved at the first attempt. This is normally grade D3 for undergraduate students and grade C3 for postgraduate students. Exceptionally it may not be possible to offer reassessment of some coursework items, in which case the mark achieved at the first attempt will be counted towards the final course grade. Any such exceptions for this course are described below. 

Reassessment is not available for group presentation which is weighted at 20%.

The specific aims of this taught course are:

• To provide a comprehensive understanding of the organisational, regulatory, and operational aspects of CTUs.

• To equip students with the skills needed to contribute effectively to CTU-led clinical trials.

• To explore emerging trends and challenges in the field of clinical trials, and their impact on the role of a CTU.

• To enable students to effectively critique those aspects of a clinical trial report relating to the role of a CTU.

By the end of this course students will be able to:

1. Critically appraise the key roles and functions of a CTU within the clinical trials process.

2. Evaluate various clinical trial designs and understand their uses and challenges for CTU delivery.

3. Critically analyse the quality of common CTU processes in trial publications.

4. Design a trial delivery pipeline for an academic CTU based on current regulations and processes.

Students must submit at least 75% by weight of the components (including examinations) of the course's summative assessment.