Clinical Trial Fundamentals (Online) - PDM1129

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 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.

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.

Fees

Full fee: $500 . $450 for student/ Alfred Staff/ Monash Staff /Monash Alumni

Course outline


This interactive online course introduces 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

For those wanting more in-depth knowledge on these topics we also offer the Clinical Trial Fundamentals Masterclass, available both with and without assessment. (The online course forms part of and is a prerequisite for the masterclass sessions.)