FDA publishes Q&A formatted guidance on "A Risk-Based Approach to Monitoring of Clinical Investigations"

The introduction highlights why the guidance (link) was needed and that is expands on a 2013 guidance.

This guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. This guidance expands on the guidance for industry Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring (August 2013) (the 2013 RBM guidance) by providing additional information to facilitate sponsors’ implementation of risk-based monitoring. 

 

But it is within the 'Background' section that the basis for using risk-based approaches are truly needed within clinical study oversight operations:

"to ensure adequate protection of the rights, safety, and welfare of participants in the clinical investigation and the integrity of the data submitted to FDA"

 

With this in mind the guidance notes that a risk-based monitoring plan should start with the protocol development, be used in site selection, and include onsite and remote (central) monitoring. The plan and process needs to be flexible in that not only risks that are identified during the protocol planning stage are addressed, but issues identified during the conduct have a process for reporting, assessing and implementing updated procedures to correct the practices that were risking patients or data integrity.  One section is devoted to the issue of assessing the adherence to study blinding - a key parameter for data integrity in blinded studies.

 

While many companies are in compliance with the 2013 guidance that laid out the foundation for risk-based monitoring, the FDA must have seen a number of best practices and gaps over the years; prompting them to write this Q&A formatted guidance.