The MCC is delighted to announce the availability of a free White Paper and webinar on Data Management and Biostatistics metrics and the impacts of ICH E6 (R2). They describe the progress that the MCC Work Group has made so far in 2017. We have defined the Critical Success Factor and Key Performance Questions (KPQs) that our metrics need to help us answer in the light of ICH E6 (R2). We have reviewed current MCC metrics that help us to answer those KPQs. This has led us to develop some new metrics – two of which are completely new and help to answer the KPQ, “what proportion of data that should be present is missing”. We have started considering exploratory metrics that focus on the critical data rather than all data as referenced in ICH E6 (R2).
Our next meeting is September 12th at 10am EDT – if your organization is a member of the MCC, why not come and join us? It’s an open space to share thoughts and ideas with your industry colleagues. You can be a thought leader!
To learn more about this work group, visit the Data Management and Biostatistics home page.