Course Catalogue

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The course will provide students with a working knowledge of the principles and methods involved in Clinical Trials.

This course will be taught in 4/5 hour blocks for a total of 20 hours, these blocks may be taught consecutively over the course of 5 days.

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Assessment

Assignment in the form of a design for a Clinical Trial (2000 words) worth 40% of final grade

Written examination worth 60% of final grade

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

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

■ Critically appraise the legal, ethical and regulatory issues underlying clinical trials

■ Critically discuss, evaluate and apply the appropriate theories, principles and methods required to construct a study design

■ Critically compare and select methods of randomisation, data collection and database management

■ Critically compare and select methods recruitment and retention

■ Critically appraise recognised methods of safety reporting and monitoring

■ Critically discuss and evaluate appropriate methods for study closedown

■ Critically compare, contrast and select appropriate methods of analysis and interpretation of trial results

■ Critically evaluate trial results and put them in to 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.