Program Overview

Clinical Trial Fundamentals (Online) - PDM1129

Overview

This modular course provides core knowledge around guidelines and frameworks underpinning clinical trial management, and the practical knowledge needed by clinical trialists to execute their duties. The course is designed for those wishing to enter the clinical research workforce as a clinical trialist, including 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.

Who Should Attend

• Clinicians
• Nurses
• Physiotherapists
• Psychologists
• Pharmacists
• Other allied health professionals
• Biomedical and public health researchers
• Clinical trial coordinators
• Those working in the health industry 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

Program Structure

The online module introduces fundamental concepts through self-paced learning. The time required is approximately 15 hours over a four-week period.

Instructors

• Dr. Marina Skiba: Dr. Skiba has 30 years of experience in clinical research with expertise in protocol development, ethics applications, data management, and project coordination. She has been involved in a variety of research from early and late phase interventional studies and mechanistic trials to community-based, observational research.
• Dr. Simone Spark: Dr. Spark has been managing clinical trials for over ten years. Before that, she worked in the public health space as a molecular biologist specializing in outbreak investigations of foodborne and hospital pathogens.

Fees

• Standard Rate: $500
• UG & PG students, Monash University Staff & Alum, Alfred Health Staff: $450

Dates

• 3 November 2025 - 1 December 2025

Location

To be confirmed

Related Programs

• Management Fundamentals for Clinical Trials: This one-day short course is designed specifically for those interested in the use of Bayesian techniques to analyze data from longitudinal studies such as clinical registries, routinely collected health data, and even cohort studies. This course is provided by the School of Public Health and Preventive Medicine.