Posted: 1 February 2024
Event: 10 April 2024
“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.
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
