| Unit name | Clinical Trials & Statistics |
|---|---|
| Unit code | SOCSM0002 |
| Credit points | 10 |
| Level of study | M/7 |
| Teaching block(s) |
Academic Year (weeks 1 - 52) |
| Unit director | Professor. Chris Rogers |
| Open unit status | Not open |
| Pre-requisites |
None |
| Co-requisites |
None |
| School/department | Bristol Medical School |
| Faculty | Faculty of Health Sciences |
This unit will provide an overview of the different types of research design, with particular emphasis on clinical trials. It aims to provide students with a good understanding of the underlying principles of clinical trial design and knowledge of the appropriate use of statistics. Examples will be taken from cardiovascular studies where possible, nonetheless the principles and techniques to be discussed apply equally to other areas of science and medicine. Students will gain an understanding and appreciation of how to conduct clinical trials successfully (e.g. appropriate data collection and case report form design for clinical studies, study size and power calculations, randomisation methods) and how to avoid common pitfalls (e.g. bias and confounding and how to minimize them). Essential concepts underlying statistical methods will be introduced (e.g. data distributions, hypothesis testing, confidence intervals, t-tests, non-parametric methods, chi-squared tests, odds ratios, relative risks etc). Students will gain sufficient knowledge to be able to identify which statistical analysis method should be employed. Mathematical formulae however, will be kept to a minimum. Importantly, the ‘general’ ethical principles of clinical research (including some historical and legal perspective on ethics) and the UK research governance framework and the EU directive governing the conduct of clinical trials will be covered.
Students successfully completing this module will be able to:
Coursework (contributing a total of 60% to the unit) consisting of:
Please note that students will be given formative feedback on all coursework assessment.
Written exam (contributing a total of 40% to the unit) consisting of:
If this unit has a Resource List, you will normally find a link to it in the Blackboard area for the unit. Sometimes there will be a separate link for each weekly topic.
If you are unable to access a list through Blackboard, you can also find it via the Resource Lists homepage. Search for the list by the unit name or code (e.g. SOCSM0002).
How much time the unit requires
Each credit equates to 10 hours of total student input. For example a 20 credit unit will take you 200 hours
of study to complete. Your total learning time is made up of contact time, directed learning tasks,
independent learning and assessment activity.
See the Faculty workload statement relating to this unit for more information.
Assessment
The Board of Examiners will consider all cases where students have failed or not completed the assessments required for credit.
The Board considers each student's outcomes across all the units which contribute to each year's programme of study. If you have self-certificated your absence from an
assessment, you will normally be required to complete it the next time it runs (this is usually in the next assessment period).
The Board of Examiners will take into account any extenuating circumstances and operates
within the Regulations and Code of Practice for Taught Programmes.
