Clinical Trial Fundamentals (Masterclass with 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.

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.

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 7 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

Assessment tasks

  • Development activities (18%) (Equivalent to 1080 words)
  • Study Question and Research Proposal Video (15%) (900 words)
  • iSAP Case Study (32%) (1440 words)
  • Study Protocol (35%) (2100 words)

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.

Accelerate your qualification

Those who undertake the 6-week formal assessment component will attain credit points equivalent to a 6-credit point unit into any of the following courses and units: Master of Public Health – M6024, Master of Clinical Research Methods – M6028, Master of Health Services Management – M6008, Master of Occupational and Environmental Health – M6026, Master of Biostatistics – M6025

Learn more at:

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:

Fee policy

Written applications to withdraw from the assessed version of a course and transfer to a non-assessed version will be accepted up to six business days prior to course commencement.

Cost of assessment is non-refundable if withdrawal occurs 5 business days or less prior to face to face course.

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.