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
Availability
Class details
Adelaide City Campus West
Class number 57270
Section LE01
Size 40
Available 33
Class number 57269
Section WS01
Size 40
Available 33
Fee calculator
To display course fees, please select your status and program below:
We’re updating this Fee Calculator. It currently shows fees for programs only. Please check the relevant program for full fee details.
Study Abroad student tuition fees are available here.
Only some Postgraduate Coursework programs are available as Commonwealth Supported. Please check your program for specific fee information.
If you are studying in a Professional Pathway Psychology or Clinical Psychology program, please refer to the Student Contributions amounts published here.
The Student Contribution amount displayed below is for students commencing a new program from 2021 onwards. If you are continuing in a program you commenced prior to 1 January 2021, or are commencing an Honours degree relating to an undergraduate degree you commenced prior to 1 January 2021, you may be charged a different Student Contribution amount from the amount displayed below. Please check the Student Contribution bands for continuing students here. If you are an international student, or a domestic student studying in a full fee paying place, and are continuing study that you commenced in 2025 or earlier, your fees will be available here before enrolments open for 2026.