Clinical Trial Fundamentals

Micro-credential

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 modular course, providing core knowledge around guidelines and frameworks underpinning clinical trial management, and the practical knowledge needed by clinical trialists to execute their duties.

Dates to be announced shortly

You are here:

Home
Courses
Find a course
Clinical Trial Fundamentals - PDM1120

Clinical Trial Fundamentals - PDM1120

Taught by clinical trialists who have overseen the day-to-day management of large-scale RCTs, and with deep experience in research governance and ethics, this flexible course gives you the option to select the level of detail you require, and to undertake formal assessment. It’s designed around key competencies for clinical trialists, based on the National Health and Medical Research Council (NHMRC) framework, and is underpinned by the International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines, making it ideal for both local and international participants.

The online module provides you with the knowledge needed to contribute to a clinical trial within established parameters, with limited responsibility, but with autonomy and sound judgment.

Overview
Who you will learn from
Find out more

Who should attend

This course is targeted at those wishing to enter the clinical research workforce as a clinical trialist, and is suitable for clinicians, 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.

What you will learn

Topics introduced in the online module and expanded on in the masterclass include:

Research design
How to interpret published research
Scientific concepts enabling the construction of research protocols and the formulation of research questions
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

Learn more at our School of Public Health and Preventive Medicine (SPHPM) postgraduate website.

Program structure

This three-day masterclass provides a deeper dive into the knowledge, skills and concepts introduced in the online learning, and provides the opportunity for interaction (via Zoom) with course coordinators and fellow students via live lectures, workshops and group activities.

Note: Completion of the online module is a mandatory requirement for admission into the masterclass (with or without assessment).

Accelerate your qualification

Eligible participants who complete the micro-credential can receive 6 credit points of unspecified credit towards Masters degrees in Public Health, Clinical Research, Health Management, Biostatistics or Occupational and Environmental Health.

Note: Successful completion of a micro-credential does not guarantee admission into an award course. Prospective students must meet the eligibility and admission requirements for the award course. A micro-credential can only be used as credit towards a single degree on one occasion, and is valid for 7 years.

For more details please email pgradenq@monash.edu or shortcourses.depm@monash.edu

Associate Professor Nicole Kalms

Dr Marina Skiba

Dr Skiba has 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 mechanistic trials to community
based, observational research.

See full bio

Associate Professor Gene Bawden

Dr Simone Spark

Dr Spark 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.