10/20/2020
Sandra “SAM” Sather lead a community discussion at Metrics Champion Consortium’s (MCC) vSummit 2020 on “The Risk-Based Monitoring Training Gap,” related to her prerecorded session on “The RBM Training Gap: Risk-Based Monitoring the Noun vs. the Verb.” The conversation was informative as to where different organizations lie on the spectrum of implementing risk-based quality management (RBQM), with attendees from large sponsors explaining that they may have policies that require them to implement 100% source data verification (SDV) regardless of risk assessment for pre-phase III trials and attendees from small to mid-sized organizations commenting that they understand the need for risk-based monitoring plans but sometimes meet challenges cross functionally.
One interesting finding through the discussion is that terminology is often not consistent across organizations or across different functional teams. For example, risk-based monitoring (RBM) may mean centralized monitoring or less than 100% SDV to some organizations (used as a noun) versus others use the term as a decision-making strategy based on risk (used as a verb). This leads to the conclusion that industry does not realize that a rationale for 100% SDV is still needed based on the risk assessment, although ICH E6(R2) requires this in 5.18 the addendum. Other confusion can arise from terms being used differently between biostats, data management and monitoring teams, as well as between the sponsor and their CRO.
There are obvious struggles within organizations to implement RBQM with individuals wishing there was a “magic wand” after hours of nonbillable time spent working on improving systems only to find that organizational silos or other challenges have gotten in the way of implementing them. Other struggles include pushing past “the way things have been” or checkbox mentality to a system of critical thinking and RBQM.
For meaningful change in the industry, challenges to overcome include understanding and overcoming:
Different attitudes and resistance to change
What really matters may differ for individuals or teams
How to offer a new strategy and show it has benefit
RBQM is for cross functional teams and not only ClinOps
Current use of tools may not promote critical thinking
How RBQM may affect the individual’s role and support their performance
Mentoring that is lacking or inadequate
How terms are defined differently and exactly what is meant by onsite or remote monitoring
Timeline or cost barriers
These challenges are opportunities for understanding and growth. Although there were anecdotal reports of micro-wins, there was no overall success story shared. This should not be seen as a sign of failure but as incremental steps towards the goal. As an industry, we must support the culture of a risk mindset that includes critical thinking as a foundation, not an afterthought.
- The Clinical Pathways Team
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