Clinical Trial Fundamentals

Knowledge of the fundamentals of clinical trials has become essential for anyone working in clinical research. Guidelines and frameworks underpin the day to day running of trials, as well as providing clinical trial staff with the practical knowledge necessary for performing their roles.

The course has been designed around the key competencies for clinical trialists (based on the framework incorporated by the NHMRC). This course is underpinned by the International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines making it ideal for both local and international participants.

Learning outcomes

  1. Understand and apply clinical trial guidelines and regulatory requirements that underpin clinical trial design.
  2. Understand and apply clinical trial administration and management, and provide specialist knowledge and advice in regards to the conduct of clinical trials.
  3. Analyse clinical trial contexts and situations, and determine appropriate evidence-based actions for managing clinical trial outcomes.
  4. Demonstrate leadership in clinical trial processes through evaluating clinical trial contexts and scenarios, including making recommendations that comply with good clinical practice.
  5. Formulate study questions and research proposals for a clinical trial protocol that complies with clinical trial guidelines and regulatory requirements.
  6. Develop a clinical trial study protocol that applies and implements the key operational competencies of clinical trial design

Who should attend

This course is targeted at health practitioners (including medical doctors, nurses, physiotherapists, psychologists, pharmacists, and other allied health professionals), biomedical and public health researchers, clinical trial co-ordinators and those working in the health industry who are interested in developing their skills and knowledge of clinical trials. It may be completed by current and prospective postgraduate students with the option of including it as part of a Master’s degree.

Course outline

This short course will consist of an interactive online component (24 hours) introducing clinical trial competencies, followed by an advanced masterclass (3 days) composed of formal lectures, small group discussions, and workshops. Students must complete the online component by 30 June 2020.

This course will cover the following topics:

  • Research design including the differences between quantitative and qualitative study designs and clinical trial phases
  • How to interpret published research including conducting systematic reviews and meta-analyses of published studies
  • 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

Accelerate your qualification

Those who undertake the assessed version of this course will attain credit points equivalent to a 6-credit point unit into any of the following Masters Degrees: M6024 Master of Public Health, M6028 Master of Clinical Research Methods, M6008 Master of Health Services Management, M6026 Master of Occupational and Environmental Health, M6025 Master of Biostatistics.

Learn more at our SPHPM Postgraduate website.

Important note: Completion of the assessed version of the short courses does not guarantee admission into an award course. For further information regarding admission into the award courses, please contact:


Course Directors

Dr Simone Spark

BSc (Hons), MPH, PhD

Senior Clinical Trials Manager - Monash University

Simone 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. Simone completed her MPH and PhD from Melbourne University and has a passion for disease prevention (both communicable and non-communicable). Her PhD involved the design of a plant based vaccine for a vaccine preventable disease in humans and animals. Her MPH specialised in epidemiology and statistical analysis. Simone has worked in all aspects of clinical trials including design, initial trial set-up (document preparation, ethics, database development), recruitment and close-out. The trials have been large multi-centre trials across Australia and within General Practices.

Dr Marina Skiba


Research manager - Monash University

Marina has nearly 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 mechanist trials to community based, observational research.  She was the Monash University’s School of Public Health and Preventive Medicine, Research Governance Officer from 2010 to 2019 and was recently appointed as the school’s Research Manager and has just completed her PhD with the Women’s Health Research Program.

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