Workshop
Good Clinical Practice
Essential knowledge for all research, ethics and clinical trial professionals.
“I had reservations about attending without having much experience with clinical trials – but the information presented was accessible and interesting. The anecdotal stories throughout also helped make some of the conceptual information more tangible. I really enjoyed the session and found real value in attending.”
Alison Harwood, HREC Officer, University of Adelaide
“This workshop was exactly what I needed. It reinforced and explained on things I already knew and opened my eyes to areas that I need to know more about. [The facilitator] was personable, engaging and provided plenty of practical examples and anecdotes from real world experience and I could see how my situation related to the GCP principles with the help of those bridges to reality.”
Julia, Wunderlich, Senior Clinical Research Fellow, Bionics Institute
How can you protect the safety of trial participants and ensure your study complies with local laws and regulations?
By keeping your Good Clinical Practice (GCP) knowledge up to date.
This immersive, interactive workshop will introduce you to GCP principles and the roles and responsibilities of all those involved in conducting research. It will also help you understand the importance of research conduct and why following GCP leads to excellent science, quality data, reducing risk and most importantly, keeping participants safe.
By strengthening your knowledge of GCP, you can ensure that your data is reliable and can be used in future studies or treatments.
You can claim 4 CPD points from this workshop.
ICH E6 (R3) Updates
The ICH E6 (R3) draft Guideline was endorsed by ICH in January 2025. This means that the Guideline is formally endorsed and now ready to be adopted by the regulatory bodies. The Guideline aims to harmonise the framework for conducting clinical studies
Further information can be found via the below links:
here and ICH endorses E6 (R3) guideline on GCP
The changes are anticipated to be implemented across the sector later in 2025. The timeline is yet to be confirmed.
All PRAXIS online courses and workshops referring to ICH GCP include the latest information. PRAXIS endeavours to ensure that courses include the most up-to-date information.
What will you learn?
At the completion of this session, you will be able to:
- Define what is meant by Good Clinical Practice and the laws and guidelines that govern the conduct of research, so you remain compliant
- Understand the roles and responsibilities of everyone involved in research, so you are able to achieve greater collaboration and success
- Demonstrate an understanding of essential documents, enabling you to achieve consistency, efficiency and standardization
- Describe the process of informed consent and what is meant by vulnerable groups, so you can complete the process confidently and efficiently
- Demonstrate an understanding of clinical trial drug management, safety reporting and safety reporting terms
- Define the importance of data collection and case report form completion and be able to identify the risks associated with poor data collection and research misconduct
Our training and education offers have been developed according to Australian and international best practice standards.
Our modules are built upon the competencies developed by the Harvard Multi-Regional Trials Centre (MRCT) and aligned to competencies recommended by the NHMRC.
These training offers are regarded as a benchmark for researchers, clinical trials, and healthcare professionals in Australia and internationally.
About the Facilitator
Sarah Piplica
Sarah is the Regulatory, Startup and Patient Partnerships Manager at University of the Sunshine Coast (UniSC) Clinical Trials Centre in Queensland. In her role, Sarah provides high level strategic advice and guidance in the overall management and compliance of extensive and complex ethics and regulatory processes, maintaining quality standards and monitoring and audit readiness.
In 2019, Sarah was awarded the Osmond Russell Scholarship from ARCS, for a project that is seeing her research and validate a patient co-authored survey to solicit regular and meaningful feedback from clinical trials participants. Sarah is passionate about advocating for patient, participant and carer involvement within the medicines development industries.
Price
$599pp plus GST
*Savings available for group enrolments and for PRAXIS partner organisations.
Next Virtual Workshop
Thursday 19 June 2025: 10.00am – 14.00pm
Thursday 11 September 2025: 10.00am – 14.00pm
Need training on demand?
This session can also be conducted virtually or at your location for groups of 10 or more. Ask us about this today.
PRAXIS Australia has the right to cancel a workshop or training session (or move the event format online) due to unforeseen circumstances. For more information regarding our Cancellation Policy and your rights as a student, please see our Student Terms and Conditions.
Suggestion box: new offers and interest areas
What would you like to see from us? This can be a topic we haven't covered yet, a course style, or a different way of delivering our courses and workshops. All suggestions are welcome and will be considered.