Clinical Trial Fundamentals - PDM1120

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.

Fees

$500 incl GST (Online module only)
$2000 incl GST without assessment
$3000 incl GST with assessment

Alumni discounted fees

10% discount for discount for Student / Alfred staff / Monash staff/Monash Alumni

Learning outcomes

  • Understand and apply clinical trial guidelines and regulatory requirements that underpin clinical trial design.
  • Understand and apply clinical trial administration and management, and provide specialist knowledge and advice in regards to the conduct of clinical trials.
  • Analyse clinical trial contexts and situations, and determine appropriate evidence-based actions for managing clinical trial outcomes.
  • Demonstrate leadership in clinical trial processes through evaluating clinical trial contexts and scenarios, including making recommendations that comply with good clinical practice.
  • Formulate study questions and research proposals for a clinical trial protocol that complies with clinical trial guidelines and regulatory requirements.
  • 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 coordinators 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 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: pgradenq@monash.edu

This short course will consist of an interactive online component (approx. 15 hours) introducing clinical trial competencies. (Enrolment in the online component only is also available.)

The online component will be followed by a 3-day advanced masterclass. These days will be delivered once per fortnight over a 6-week period via Zoom. Each day of the masterclass will involve formal lectures (some pre-recorded and available before the day), small group discussions and activities.

For people electing to complete the masterclass with the assessments, the 4 assessment tasks will be due throughout the 6 weeks that the masterclass is running.

The 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

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

Course structure

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 1 is a mandatory entry requirement

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. Level 1 is a mandatory entry requirement