Clinical Trial Standard Operating Procedures (SOPs) Made Easy

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:

  1. The role and purpose of SOPs and operating guidelines
  2. The new national SOPs and how they apply to your work
  3. ICH, GCP and SOPs – understanding your responsibilities
  4. How SOPs, operational guidelines and other internal guidance documents relate to each other
  5. How much detail should be included in each document
  6. How each document is going to be implemented and appropriate oversight and review processes managed
  7. 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

Find out more and register to attend.


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