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.
Clinical Trial Standard Operating Procedures (SOPs) Made Easy
“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
Facilitated by Melinda Goldman, Senior Project Manager
Melinda Goldman has extensive experience in the Clinical Trials sector, working on both pharmaceutical and medical device studies, for industry-sponsored and grant-based studies. Melinda has a background in site business development, start-up management, clinical trial finance and participant recruitment. She has over 12-years’ experience in clinical trials and operations management, backed by a track-record in business development and a Bachelor of Business Management.
Melinda is the Senior Projects Manager with PRAXIS Australia. She leads the PRAXIS’s national Clinical Trial Coordinator Internship Program and supports research staff with their research training needs. She is passionate about education for clinical professionals to ensure sustainability for research sites in Australia.
$599pp plus GST
*Savings available for group enrolments and for PRAXIS partner organisations.
Next Virtual Workshop
Thursday 29 February 2024: 10.00am – 14.00pm
Wednesday 10 April 2024: 10.00am – 14.00pm
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