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Category: Metrics

Ask the Experts: ICH E6 R2 Requirements

Q: ICH E6 R2 requires us to focus particularly on critical data and processes in quality risk management. Do you have any metrics that help assess whether our efforts are focused in this way? (Metric Insights Aug. 2021)  A: This was a topic of discussion in the Centralized & Site Monitoring Process Metrics Work Group meetings earlier […]

Ask the Experts: Vendor Oversight

Q: One of our vendor oversight metrics measures whether our CRO has billed us for the amount that we expect by quarter. We are finding that this sometimes green even though we know there are problems with costs not matching the work that should have been completed. Or it might be red but when we drill […]

Ask the Experts: Risk-Based Monitoring

Q: Since we implemented Risk-Based Monitoring we have been trying to monitor the process to determine how well it is working. We have developed metrics such as whether alerts from Centralized Monitoring are closed on time but are uncertain what to use as a target. How are other organizations approaching this? (Metric Insights, Jan. 2021)  A: With […]

Ask the Experts: KRI Thresholds

Q: We are accelerating implementation of our Centralized Monitoring program due to the COVID-19 pandemic. We’ve started with a small number of Key Risk Indicators (KRIs) including AEs/patient. We have upper and lower threshold limits, so we can look for outlier sites – those that are over- or under-reporting relative to others. But what we’ve […]