Clinical research quality is traditionally managed through procedural oversight and auditing. However, the greatest threat to data integrity often resides in the "human factor"—specifically, the structural burnout produced by systemic organizational misalignment. This session will reframe workforce instability as a critical risk factor according to International Council for Harmonization (ICH) E6(R3) quality management system expectations.

Utilizing the Structural Analysis of Social Behavior diagnostic, the presenter will examine how behavioral friction in leadership and study teams creates "noise" that compromises protocol adherence and data accuracy. Attendees will learn to identify these behavioral risk indicators before they manifest as critical audit findings, thus moving beyond reactive Corrective and Preventive Action plans toward a proactive Quality by Design approach that protects the integrity of clinical data by stabilizing the human infrastructure that generates it.

CEU: 1.0 ACRP

Speaker:

• Ashley Gibson, MEd, MFA, NCC, LRC, Founder & Principal Strategist, Meaning in Practice