Standard operating procedures (SOPs) are written formal documents that describe how a person 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.
As our sector is impacted by possible downturns in business related to Covid-19, now is a good time to review your internal processes and systems to ensure they are robust when we return to full operational capacity.
There are already many templates available publicly that sites can use to develop their basic menu of SOPs. However each study may require its own new SOPs or Operating Guidelines created to support best practice. Issues often raised when writing procedures include:
How SOPs, operational guidelines and other internal guidance documents relate to each other;
How much detail should be included in each document; and
How each document is going to be implemented and appropriate oversight and review procesess managed .
This webinar will help sites to work their way through these common chalenegs and will provide additional templates that can be adapted to suit their own unique needs for current and future studies.
Melanie Gentgall, CEO PRAXIS Australia
Dr Sophie Mepham, ICON