Writing Clinical Trials SOPs – Essential Skills
In this workshop we’ll provide you with guidance on getting started – or improving your current SOP repository or format, with a focus on aligning to emerging requirements around Quality Management standards and principles.
Standard operating procedures (SOPs) are written formal documents that describe how an individual will perform a task, and how to document the performance of that task. They provide a set of ‘how to’ instructions : what to do, how to do it, when to do it and how to document the completion of the activity. SOPs define best practice in many businesses where quality standards exist and are a critical element of a clinical trials practice, according to ICH GCP.
There are already many templates available publicly that sites can use to develop their basic menu of SOPs – and there is never any point recreating the wheel. However, each study may require its own new SOPs or Operating Guidelines created to support best practice. In this workshop we’ll provide you with guidance on getting started – or improving your current SOP repository or format, with a 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.
What you’ll learn:
1. The role and purpose of SOPs and Operating Guidelines
2. How SOPs, operational guidelines and other internal guidance documents relate to each other.
2. How much detail should be included in each document; and
3. How each document is going to be implemented and appropriate oversight and review processes managed
4. 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
- A better understanding of how to embed quality into your SOP repository
- A toolkit of helpful resources
Facilitated by Melanie Gentgall, CEO PRAXIS Australia and Dr Sophie Mepham, Executive Manager Research, ICON.