Critical-to-Quality (CtQ) Factors for RBM: Selecting, Operationalizing, and Defending What Matters
Critical-to-Quality (CtQ) Factors for RBM: Selecting, Operationalizing, and Defending What Matters Focusing on What Decides Quality: CtQ Factors for Risk-Based Monitoring and Remote Oversight What “Critical-to-Quality” Really Means in Modern Trials Critical-to-Quality (CtQ) factors are the small set of design and operational elements whose failure would meaningfully jeopardize participant rights, safety, or the credibility of…