Clinical Trial Fundamentals
Knowledge of the fundamentals of clinical trials has become essential for anyone working in clinical research. Gain the skills and confidence you need through this modular course, providing core knowledge around guidelines and frameworks underpinning clinical trial management, and the practical knowledge needed by clinical trialists to execute their duties.
ONLINE MODULE
OPEN FROM 3 AUGUST – 31 AUGUST 2026
The time required to complete the online module is approx. 15 hours over a four-week period.
MASTERCLASS
Day 1: Friday 13 MARCH 2026
Day 2: Friday 27 MARCH 2026
Day 3: Friday 10 APRIL 2026
9am – 5pm each day
*** Please note that completion of the Online Module is a mandatory entry requirement for the Masterclass***
Course fees
See Course structure and pricing below.
Program contact
Phone: +61 3 9903 0289
Terms and Conditions
Course registration closes one week prior to the course commencement date.
Taught by clinical trialists who have overseen the day-to-day management of large-scale RCTs, and with deep experience in research governance and ethics, this flexible course gives you the option to select the level of detail you require, and to undertake formal assessment.
It’s designed around key competencies for clinical trialists, based on the National Health and Medical Research Council (NHMRC) framework, and is underpinned by the International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines – making it ideal for both local and international participants.
The ONLINE MODULE provides you with the knowledge needed to contribute to a clinical trial within established parameters, with limited responsibility, but with autonomy and sound judgment.
The MASTERCLASS WITHOUT ASSESSMENT takes a deeper dive, conferring the ability to contribute to a clinical trial at a higher level, with defined responsibilities including specialist advice and functions.
The MASTERCLASS WITH ASSESSMENT requires successful completion of carefully planned tasks that demonstrate the knowledge, adaptability, leadership, and expert judgment needed to contribute to the formulation or management of a clinical trial. The practical assessment will provide graduates with credit points that may contribute to a Masters degree. Former students who have successfully completed the assessment for this course can apply for prior credit here.
Topics introduced in the ONLINE MODULE and expanded on in the MASTERCLASS include:
- Research design
- How to interpret published research
- Scientific concepts enabling the construction of research protocols and the formulation of research questions
- Clinical trial governance
- Research ethics and good clinical practice
- Core competencies such as study feasibility, study initiation, trial registration, staff training and supervision, monitoring and study retention
- Legal responsibilities of clinical trials
- Clinical trial budgets, including their design and review
- The fundamentals of good data management
- Participant safety in trials
- The set-up and management of biobanks
- End of study activities, including final study reporting and data locks
Optional:
Enrolment in the ONLINE MODULE gives you access to the following optional content:
- Conducting trials outside Australia: This module will give you an insight into select international regulatory landscapes.
- Professionalism in clinical trials: These three modules, developed by TrialHub, introduce concepts of your role and scope of practice in clinical trial participant safety management and advocacy. They explore your responsibilities as a professional in this space and potential opportunities available to you for ongoing skills development, maintaining currency of practice and overall career development.
Participation in the MASTERCLASS (with and without assessment) gives you access to a maximum of 60 minutes of 1:1 work integrated learning mentorship across 1 or 2 sessions.
Course structure and pricing
10% discount for undergraduate and postgraduate students, Monash University staff and alumni and Alfred Research Alliance members.
ONLINE MODULE | MASTERCLASS | MASTERCLASS |
|---|---|---|
$500 incl. GST The ONLINE MODULE introduces fundamental concepts through self-paced learning. The time required is approximately 15 hours over a four-week period. Open from NOTE: Completion of the ONLINE MODULE is a mandatory requirement for admission into the MASTERCLASS (with or without assessment). | $1,500 incl. GST This three-day MASTERCLASS provides a deeper dive into the knowledge, skills and concepts introduced in the online learning, and provides the opportunity for interaction (via Zoom) with course coordinators and fellow students via live lectures, workshops and group activities. Day 1: Fri 13 MARCH 2026 No formal assessment is undertaken but attendance at all 3 days is required; the ONLINE MODULE is a mandatory pre-requisite. | $2,500 GST-free The MASTERCLASS can be undertaken with formal assessment. Assessment involves four tasks, and provides graduates with 6 credit points accepted by Monash Masters degrees in public health, clinical research, health management, biostatistics or occupational and environmental health. Marks are not transferable when credit is awarded, as per Monash policy and procedure. Day 1: Fri 13 MARCH 2026 Attendance at all 3 days is required. The ONLINE MODULE is a mandatory pre-requisite. |
Who should attend?
This course is targeted at those wishing to enter the clinical research workforce as a clinical trialist, and is suitable for clinicians, nurses, physiotherapists, psychologists, pharmacists, and other allied health professionals; biomedical and public health researchers; clinical trial coordinators; and those working in the health industry who are interested in developing their skills and knowledge of clinical trials.
Course partner
This course is a partnership between Monash University and TriaHub.
Course facilitators
Work Integrated Learning mentor
While the information contained herein was correct at the date of publication, Monash University reserves the right to alter procedures, fees and regulations should the need arise.