Clinical Trials 101: The fundamentals you need to know
Are you a researcher, PI, new to clinical trials or need a refresher? Clinical Trials 101 is a great place to start.
Clinical Trials 101 covers several of our workshop topics into two sessions to provide you with the fundamental knowledge of working in the sector.
This interactive workshop series will help you develop a better understanding of the clinical trial process, including all the steps to plan, conduct and evaluate clinical trials and meet regulatory requirements. You will also learn about the responsibilities of the team at each step in the process.
You will get the opportunity to interact with the group and gain different perspectives from others working across the sector.
Part 1 and part 2 are stand alone workshops and can be completed separately. However, as they compliment each other, we advise to complete both.
You can claim 3 CPD points on completion of each workshop.
Part 1: The Australian Landscape
Part 1 covers an introduction to Clinical Trials (trial types – phases, commercial and non-commercial, investigator initiated, first in human and terminology), GCP, roles, and responsibilities of stakeholders, regulation, ethics, governance and navigating regulatory requirements, the critical role of project planning – project and organisational-wide considerations, and consumer priorities.
Part 2: Feasibility and Start-up
Part 2 covers the start-up process, resourcing (people, process, infrastructure), recruitment, budgets, identifying barriers to efficient start-up, and the feasibility process.
What will you learn?
On completion, you will:
Melinda Goldman is the Business Development Manager at Genesis Research overseeing all new study feasibilities, contracts and financial management for the research centre.
Mel’s interests lie in the development of progressive services for clients and participants, as well as furthering business education for clinical professionals to ensure sustainability for clinical research sites in Australia.
Tim is a veterinarian and was previously a senior executive at the National Health and Medical Research Council, responsible for human and animal research ethics. He chaired the last NHMRC review of the Australian Code for the Care and Use of Animals for Scientific Purposes (2013).
Currently Tim chairs two animal ethics committees and is an executive coach at Leading Well Pty Ltd.
$550pp plus GST (part 1 and part 2 priced separately)
Discounts apply for more groups of 10 or more.
2022 Virtual Workshop Dates
PART 2 – Thursday, 26th May 2022: 10.00am – 14.00pm
PART 1 – Tuesday, 21st June 2022: 10.00am – 14.00pm
PART 2 – Thursday, 7th July 2022: 10.00am – 14.00pm
PART 1 – Wednesday, 20th July 2022: 10.00am – 14.00pm
PART 2 – Thursday, 4th August 2022: 10.00am – 14.00pm
PART 1 – Wednesday, 7th September 2022: 10.00am – 14.00pm
PART 2 – Tuesday, 20th September 2022: 10.00am – 14.00pm
PART 1 – Thursday, 6th October 2022: 10.00am – 14.00pm
PART 2 – Thursday, 20th October 2022: 10.00am – 14.00pm
PART 1 – Wednesday, 23rd November 2022: 10.00am – 14.00pm
PART 2 – Thursday, 8th December 2022: 10.00am – 14.00pm
Please note part 1 and 2 are stand alone workshops and require separate enrolments.
PRAXIS Australia has the right to cancel a workshop or training session (or move the event format online) due to unforeseen circumstances such as low registration/attendance numbers or changes in Government restrictions surrounding the ongoing COVID19 pandemic. For more information regarding our Cancellation Policy and your rights as a student, please see our Student Terms and Conditions document.