Clinical Trial Fundamentals (Masterclass without assessment)


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.

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. The course has been designed around the key competencies for clinical trialists (based on the frameworks incorporated by the NHMRC and developed by the US-based Clinical Trials Transformation Initiative). 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 objectives

Upon successful completion of this course you will be able to:

  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.

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.