Course overview
This course will teach the practical aspects of clinical trial conduct such as synopsis and protocol writing, principles of informed consent, study conduct and follow up, adverse event reporting, report writing, as well as the principles of Good Clinical Practice. This will be done within the regulatory and reporting framework for clinical trials.
Course learning outcomes
- Interpret the principles of Good Clinical Practice, and be able to apply these in practice
- Summarise the regulatory requirements for clinical trials including the roles of ethics and governance
- Articulate critical aspects of informed consent in the clinical research setting
- Summarise importance of adverse event documentation in clinical research
- Create a user friendly and Good Documentation Practice compliant case report form (CRF)
- Illustrate critical aspects of trial monitoring
- Interpret or design different components of a clinical trial protocol