Impact of ICH E6 (R2) - Data Management Metrics White Paper

By Metrics Champion Consortium
Published: September 2017

This paper addresses the revision of the GCP-ICH Eg (R2) and defines the Critical Success Factor and Key Performance Questions (KPQs) that are needed to answer questions due to the revision. The MCC work group has also developed two new metrics that help to answer KPQs.

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