Risk Based Monitoring from a Phase I Clinical Site Perspective2 February 2021
Request a copy of our scientific poster entitled, "Risk-based Monitoring from a Phase I Clinical Site Perspective."
Risk-Based Site Monitoring (RBSM) has been developed as an effective approach to overseeing clinical trials without compromising ethics, volunteer safety, data integrity, quality, timelines, and regulatory compliance. This approach is based on risk assessment, mitigation, and when possible, the removal of risks allowing the allocation of the resources in the activities where they are needed the most.
This approach improves the efficiency of the clinical trial site as the effort proactively concentrates on areas where the risks are deemed high, and a possible deficiency may be expected if the risk is not mitigated or removed.