Clinical Trial Fundamentals (Online) - PDM1129

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 masterclass 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.

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.

What you will learn

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

Program structure

The online module introduces fundamental concepts through self-paced learning. The time required is approximately 15 hours over a four-week period.

Note: Completion of the online module is a mandatory requirement for admission into the masterclass (with or without assessment).

Associate Professor Nicole Kalms

Dr Marina Skiba

Dr Skiba has 30 years experience in clinical research with expertise in protocol development, ethics applications, data management and project co-ordination.  She has been involved in a variety of research from early and late phase interventional studies and mechanistic trials to community
based, observational research.

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Associate Professor Gene Bawden

Dr Simone Spark

Dr Spark has been managing clinical trials for over ten years. Before that she has worked in the public health space as a molecular biologist specialising in outbreak investigations of food borne and hospital pathogens.

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See terms and conditions for this course.

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