Course overview
This course will teach the practical aspects of clinical trial conduct emphasising the core principles of the practical applications of Good Clinical Practices, informed consent, adverse event reporting, case report form design, as well as designing protocols for the conduct of different phases of drug 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 important considerations in trial design to achieve the safety and efficacy goals of a clinical trial
- Describe important considerations in adverse event documentation in clinical research
- Create a user friendly and Good Documentation Practice compliant case report form (CRF)
- Contrast different designs considerations for trial protocols in different phases of clinical trials
Availability
Class details
Adelaide City Campus West
Group 1
Class number 57269
Section WS01
Size 40
Available 22
Class number 57270
Section LE01
Size 40
Available 22
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