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 three-part stackable course, providing core knowledge around guidelines and frameworks underpinning clinical trial management, and the practical knowledge needed by clinical trialists to execute their duties.

Register here

Course dates

Open from 18 July 2022
to 29 August 2022

(Registrations close 13 July 2022)

3 March, 17 March and
31 March 2023

The Online Module is a mandatory entry requirement for the Masterclass.

(Registrations close 27 February 2023)

Course fees

See Course structure and pricing below.

Program contact

Phone: +61 3 9903 0289

Terms and Conditions

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.

Level 1 (Online) provides you with the knowledge needed to contribute to a clinical trial within established parameters, with limited responsibility, but with autonomy and sound judgement.

Level 2 (Masterclass without assessment) takes a deeper dive, conferring the ability to contribute to a clinical trial at a higher level, with defined responsibility including specialist advice and functions.

Level 3 (Masterclass with assessment) requires successful completion of carefully planned tasks, that demonstrate the knowledge, adaptability, leadership, and expert judgement 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.

Topics covered include:

  • Research design
  • How to interpret published research
  • Scientific concepts enabling the construction research protocols and the formulate of research question
  • 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

Course structure and pricing

A 10% discount is available across all levels for current Monash students, staff and alumni, as well as Alfred Health staff and VHA members.

Level 1* Online Module

Level 2 Masterclass
(no assessment)

Level 3 Masterclass
(with assessment)

$500 incl. GST

Level 1 comprises the online module, introducing fundamental concepts through self-paced learning.

The time required is approximately 15 hours over a six-week period.

The Level 1 Online Module is open between:

  • 18 July 2022 –
    29 August 2022

    (enrolment open until
    13 July 2022)

*Completion of Level 1 is a mandatory requirement for admission into Levels 2 and 3.

$2,000 incl. GST including enrolment into either the Level 1 Online Module, OR $1,500 incl. GST if you have already completed the Level 1 Online Module.

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. This component is run on three full days:

  • 3 March 2023
  • 17 March 2023
  • 31 March 2023

No formal assessment is undertaken but attendance at all 3 days is required.; Level 1 is a mandatory entry requirement.

$3,000 incl. GST including enrolment into the Level 1 Online Module, OR $2,500 incl. GST if you have already completed Level 1 Online Module.

Level 3 is the addition of formal assessment to the curriculum described in Level 2. 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.

Final assessment is due
23 April 2023.

Attendance at all 3 days is required. Level 1 online is a mandatory entry requirement.

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 facilitators

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.