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:
- RBM is a new requirement of the ICH GCP guidelines
- RBM is just reduced source document verification (SDV)
- Technology alone can solve RBM
- Machine learning RBM solutions are costly and complicated to implement
- RBM cuts clinical investigators out of the loop
Please complete the following form to access this resource. You will only be asked to do this once.