The course will provide students with a working knowledge of the principles and methods involved in Clinical Trials, including background, ethics, randomisation, statistics, and reading clinical trial papers.  The course is lecture-based although lectures are interactive and there will be some group work.

This course is made up of lectures and practical classes in semester 2.

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Assessment

1. 1000 word essay describing a hypothetical class debate about an ethical issue in clinical trials (25%) (ILOs 1 and 2)

2. A multiple choice quiz (30%) (ILOs 1-6)

3. 15 minute presentation with poster and 1-page reflective writing piece (45%) (ILOs1-6)

This course aims to provide students with the opportunity to develop their confidence and skill to apply the foundational principles and methods required for conducting Clinical Trials

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

1. Critically appraise legal and regulatory issues underlying clinical trials.

2. Critically discuss, evaluate and apply the appropriate ethical issues, theories, principles and methods required
to construct a study design.

3.  Show understanding of processes behind data collection and database management, safety reporting and
monitoring, and processes that occur at study closedown and archiving

4. Critically evaluate methods of recruitment and retention

5. Compare, contrast and select appropriate methods of analysis and interpretation of trial results

6. Critically evaluate trial results and put them into context, using judgement and supporting conclusions

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