In March 2019 the FDA released their RBM Q&A Guidance for Industry.
If you haven’t read it yet, the link is below, it makes for some interesting reading. The focus of this guidance is to provide further clarification and suggestions on how best to implement risk based approaches to monitoring.
Interestingly the guidance focuses very heavily on the risk to critical data and processes and adapting the monitoring plan to address these risks.
Below are a few highlights that I have picked out:
- Sponsors should identify critical data and processes and assess the risk to those items
- Monitoring strategy should be designed to focus on the risks that are high impact and most likely, and also consider risks that are high impact but less likely to happen
- Monitoring plans should outline the risks and the controls, and how to identify problems early and implement corrective/preventative actions
- Monitoring plan should evolve over time based on real world evidence
- Communication of central monitoring findings should be to sponsor representatives responsible for investigation and site oversight, and also to the sites if the findings are relevant to their activities
If you’d like to know more about how the guidance affects RBM compliance in your organisation, please get in touch via firstname.lastname@example.org