Debunking the Myths of Risk-Based Monitoring for a New Approach to Quality Management

Get the straight story on RBM in our new white paper

Over the past few years, there has been much debate regarding the definition of risk-based monitoring. To put it in context, clinical monitoring – otherwise known as “traditional” monitoring – describes the oversight and administrative efforts involved in monitoring both a participant’s health and the efficacy of the investigative drug during a clinical trial. Risk-based monitoring (RBM) is a modified resolution of the clinical monitoring schema which employs quality management principles and is characterized by its promotion of a risk mitigation strategy.

There are many misconceptions associated with risk-based monitoring in the clinical setting. In this white paper, we focus on debunking five of the most common myths around risk-based monitoring:

1. RBM is a new requirement of the ICH GCP guidelines

2. RBM is just reduced source document verification (SDV)

3. Technology alone can solve RBM

4. Machine learning RBM solutions are costly and complicated to implement

5. RBM cuts clinical investigators out of the loop

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