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While patient safety remains the primary concern of guidance ICH E6, revision 3 further directs sponsors to include patients in the research process. In part two of our RBQM video series, Amy Kissam-Sands and Tim Audin, Senior Director, Global Biometrics Group Lead talk with Taren Grom, Editor, PharmaVOICE about how to implement a proactive risk-management approach and address patient input in study design.
