The International Council for Harmonization (ICH)  E6(R3) guideline for Good Clinical Practice pushes trial teams to collect less, but more important, data while maintaining a focus on critical-to-quality factors, avoiding unnecessary data fields, and designing collection around the protocol’s real risks and objectives. It also shifts strategy toward risk-based quality management, stronger data governance, and fit-for-purpose digital systems with traceable audit trails. This session will examine how, in practical terms, E6(R3) means data collection planning must start during protocol design, with a clear map of which data are critical and why. For trial teams, earlier input by data management and informatics experts results in quality-driven collection, rather than volume-driven collection, with a clear path to operational success.

CEU: 1.0 ACRP

Speaker:

• Jaime Baldner, Research Informatics Director, University of Arkansas for Medical Sciences