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This module is aimed at healthcare professionals whose work directly involves them in clinical trials or those who wish to become involved in such work. This will include principal investigators, clinical research nurses, clinical trial managers and clinical trial administrators. The module can provide continuing Professional Development for any healthcare researchers.
It will facilitate demonstration of training required by the European Directive 2001/20/EC and the Medicines for Human Use (Clinical Trials) Regulations 2004. The module will offer students an opportunity to understand the principles of how to plan and manage clinical trials on human volunteers in accordance with current good clinical practice. Also, to explore and critically analyse applying the knowledge and skills in their own working environment.
The module will use a blended learning approach of a workbook supported by electronic learning materials. Participative work within groups in an electronic discussion or bulletin board format will enable students to explore a variety of issues around research planning and project management. Throughout the module, the students will be encouraged to extend their knowledge and become familiar with key documents covering relevant policy and practice via the Internet.