VIRTUAL WORKSHOP
Clinical Trial SOPs: Essential Skills
“This workshop was very useful for the changes that are coming in Australia regarding the conduct of clinical trials [in 2023-24].” – Louise Jaensch, Clinical Trial Coordinator, SA Health
“Presented thoroughly and efficiently and with variation in delivery.” – Christine Cocks, Clinical Nurse Researcher, Sunshine Coast Hospital and Health Service
“Very informative workshop that helps make SOP development an achievable task, not a daunting task. Great for site coordinators and investigators.”
Margaret-Ann Tait, Research Manager, University of Sydney
Standard operating procedures (SOPs) help to make job functions standardised within your team and improve quality outcomes for your research organisation. They are a critical element of clinical trial practice, according to ICH GCP, supporting ongoing knowledge sharing for research personnel. SOPs are a critical part of your Quality Management System and an excellent resource for staff training.
In this workshop, we’ll provide you with best-practice guidance for SOP development. We’ll focus on aligning to emerging requirements around Quality Management standards and principles as articulated in ICH GCP and other guidance including ISO 14155:2020 – GCP for Medical Devices and the National Standard Operating Procedures for Clinical Trials documentation.
You can claim 4 CPD points from this workshop.
Who is this workshop for?
- Clinical Trial Coordinators
- Clinical Trial Managers
- Ethics and governance staff
- Clinical Trial Associates
What you’ll learn:
- The role and purpose of SOPs and operating guidelines
- The new national SOPs and how they apply to your work
- ICH, GCP and SOPs – understanding your responsibilities
- How SOPs, operational guidelines and other internal guidance documents relate to each other
- How much detail should be included in each document
- How each document is going to be implemented and appropriate oversight and review processes managed
- Including “why” – incorporating quality and risk management principles into your SOPs
What you’ll leave with:
- Renewed confidence in reviewing and improving your current systems and processes
- Understanding the difference between work instructions and SOPs
- A better understanding of how to embed quality into your SOP repository
- A toolkit of helpful resources
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 1 May 2025: 10.00am – 14.00pm (AEST)
Thursday 14 August 2025: 10.00am – 14.00pm (AEST)
Thursday 20 November 2025: 10.00am – 14.00pm (AEST)
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.