Duncan Hall’s feed-back from FDA presentation on Risk-Based Quality Management

July 19th, 2019:

I’ve just got back from the FDA’s “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations” event on Wednesday 17th.

It was a truly great event, and well worth the trip over the pond! It was really exciting to see alignment between the regulatory authorities, the sponsors and CROs and a unanimous view that risk-based quality management is not only a no-brainer from a regulatory requirement context, but also from the fact that doing it properly can significantly improve safety, quality and efficiency in clinical trials – so what’s not to like?

There were a few quotes I wanted to share as I think the summarise the event perfectly:

Can we stop calling it Risk-Based Monitoring and call it Risk-Based Quality Management – it’s not just about monitoring, it is an end to end process”

 “Regulatory compliance and quality in clinical trials are not the same thing”

 “Source data verification (SDV) is only the search for transcription errors”

And finally a section from one of the slides from Dave Burrow of the FDA:

“When good quality risk management and quality by design processes inform the development of RBM, effective implementation of RBM can maximise study quality by focusing monitoring activities on processes and procedures critical for the protection of trial participants and managing data integrity.”

Thanks to the FDA, the event organisers and the great set of industry experts on the panel. Risk-Based Quality Management is clearly here to stay, so let’s embrace the opportunity it presents and make sure we’re compliant in the process.