In the highly regulated field of clinical trials, precision, compliance, and clarity are fundamental. Standard Operating Procedures (SOPs) form the structural framework that supports consistent, high-quality trial operations. Despite their critical role, many professionals find SOP development challenging—particularly when balancing regulatory requirements with practical usability.
PRAXIS Australia’s virtual workshop, Writing Clinical Trials SOPs: Essential Skills, addresses this need by equipping participants with the expertise to craft SOPs that are both compliant and functional in real-world settings. This workshop offers targeted, practical training to enhance your ability to write SOPs that support operational excellence and meet regulatory expectations.
Why Effective SOPs Matter
SOPs are not merely procedural documents—they are central to quality assurance, operational efficiency, and risk mitigation. Well-constructed SOPs:
-
Minimise the risk of non-compliance and regulatory breaches
-
Standardise practices across diverse teams and sites
-
Improve adherence through clarity and accessibility
-
Embed quality principles into daily operations
In clinical research, where regulatory scrutiny is high and the margin for error is minimal, inadequate SOPs can lead to protocol deviations, compromised data integrity, and potential harm to participant safety.
What the Workshop Covers
This interactive session provides practical tools and techniques for writing high-quality SOPs, including:
-
Regulatory requirements and expectations (ICH GCP, NHMRC, and more)
-
Effective document structure and formatting for usability
-
Clear, concise language tailored to diverse stakeholder groups
-
Common pitfalls in SOP development—and how to avoid them
-
Case studies, peer discussion, and hands-on writing exercises
Meet the Facilitator
The workshop is facilitated by Sarah Piplica, Regulatory, Startup and Patient Partnerships Manager at the University of the Sunshine Coast (UniSC) Clinical Trials Centre in Queensland. Sarah brings extensive experience providing strategic oversight and ensuring compliance across complex ethics and regulatory frameworks. Her work supports continuous quality improvement and audit readiness within clinical trial operations.
In 2019, Sarah was awarded the Osmond Russell Scholarship from ARCS Australia to support her innovative work developing a patient co-authored survey for collecting meaningful, ongoing feedback from clinical trial participants. She is a passionate advocate for the integration of patient, participant, and carer perspectives in the development of medicines, and her approach bridges regulatory compliance with person-centred care.
Who Should Attend
This workshop is ideal for clinical trial coordinators, project managers, research governance professionals, and quality assurance personnel seeking to enhance their SOP development capabilities. Whether you are new to SOP writing or looking to refine your existing skills, this training offers valuable insights and practical takeaways.
Invest in Quality, Improve Outcomes
In an increasingly complex research landscape, the ability to develop clear, compliant, and effective SOPs is indispensable. This workshop offers a timely opportunity to enhance your professional skills and contribute to the quality and integrity of clinical research.
Secure your place in this high-value learning experience.