This module aims to familiarise students with a range of practical issues surrounding different forms of clinical research and with enhanced principles of research governance. It also aims to enhance the knowledge of the science behind research at an international level and allow students to reflect on their academic career. The module is designed to prepare students to plan and conduct original clinical research by providing them with specific knowledge and enabling them to develop understanding of the subject as well as a portfolio of skills to this end. The module will also provide students with knowledge of legal requirements for performing research outside the UK.
The module will be delivered in an attendance-based format, with two teaching days (one full day and two half days) on campus supported by self-directed learning.
Outline of syllabus:
- Current legislation and the law - the European perspective
- Post-marketing surveillance
- The science of research - understanding the 'ologies'
- The academic career journey - how did I get where I am today
- Managing intellectual property
- Be aware of current legislation relating to different forms of clinical research
- Have an understanding of the current issues related to governance in different forms of clinical research
- Have an understanding of the local and national regulations and processes for obtaining permissions and approval for clinical research
- Have an understanding of the need for good practice in clinical research
- Have an understanding of the need for effective governance in clinical research
- Be able to apply knowledge of ethical principles and theories to clinical research projects
- Be able to prepare and evaluate required paperwork for real clinical research projects including, for example, applications for a favourable opinion from research ethics committee; forms for informed consent for clinical trials.
The teaching dates for academic year 2010/11 have now been set and will be as follows: 12/10/10; morning of 14/12/10; morning of 25/01/11.