MCC members are invited to an online meeting on February 12, 2019 to learn about the cutting edge work being discussed in the MCC’s Central Lab Metrics Work Group and the opportunity to expand the discussion into the Imaging Metrics Work Group.
This reconvening work group will review the Imaging metric set and explore opportunities to use data from the collection and analysis of imaging scans to provide a signal of risk at individual sites or for the study. Specifically, the new work group will explore the following:
- Look at the image collection and analysis process from the perspective of Quality Risk Management as defined in ICH E6(R2) section 5.0 and define the process steps of highest risk
- Review existing metrics and determine which could be used as Key Risk Indicators and whether there are metric gaps for the high risk process steps
- Update the existing metrics to add information now included in other MCC metric sets such as, what the metric does not tell you, metric level (portfolio, study, site), data elements, advanced/basic metric designation
- Develop implementation support tools – similar to those already in use with other metrics sets – including:
- Sponsor/vendor metric selection tool
- Common issues to metric mapping tool
- Implementation case studies
The Imaging Work Group will hold one-hour virtual meetings on a monthly basis. This meeting will be of interest to people who manage Imaging Core Lab services, Imaging data and/or quality risk management, including risk management, centralized monitoring and/or risk-based monitoring. Participating in this MCC work group is a great opportunity to share your experience with other clinical trial professionals across the industry and to help shape the industry approach to use of imaging data for quality risk management in the future.
MCC members interested in participating in the Imaging Work Group meeting can click here to register.