RBQM For Decentralized Trials: Two Key Areas Of Focus To Reduce Your Risk

Whilst the implementation of RBQM is growing, the use of the term ‘risk’ in RBQM could still be hindering implementation or buy-in within organizations because a risk may be thought of as ‘bad’. However, a risk is merely a potential future issue, while an issue is a current problem that requires resolution. 

Today, many industry resources focus on how to approach RBQM and why sponsors should be moving to implementation, including interpreting what is required and how to get started. However, these articles tend to cover items 5.0.1 through to 5.0.4 as per ICH-GCP E6 R2, when in fact the true “heavy lifting” starts at Sections 5.0.5: ‘Risk Communication’ and 5.0.6: ‘Risk Review.’ This article takes a more in-depth look at these two sections to show how the implementation of RBQM can reduce issues and achieve holistic trial oversight in today’s complex decentralized trials.