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Introduction to Clinical Trials and Good Clinical Practice for Ethics Committee Members

Course Outline: This session provides ethics committee members with a better understanding of clinical trials and the ethical issues associated with this sub-set of research. Through a mixture of discussion and presentation, the session explores the application of the ethical values and principles in the National Statement and introduces the quality and ethical standard, Good Clinical Practice (GCP). GCP is the framework that enables researchers to design, manage and conduct their trials in a manner that protects both the rights, safety and well-being of participants, and the credibility of trial data.

Price: $1400 + GST per session for up to 20 attendees
Mode of delivery: Live, interactive Zoom or Teams session
Duration: Two hours plus 20 minutes pre-reading in preparation for a workshop

Learning Objectives
• Be familiar with key historical events that have shaped trial regulation
• Understand the assessment of benefits and harms, and when a trial can be considered low risk
• Be aware of the reporting requirements for trials
• Identify the roles and responsibilities of key players
• Be reminded of the requirements for trial consent, including when waiver of consent may be acceptable
• Be familiar with key ethical issues, including those relating to payment to participants and post-trial access to trial treatment
Certification: Certificate provided on course completion
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