Section 5 establishes sponsor responsibilities and quality management. Sponsor must implement a Quality Management System (QMS) per R3 covering: risk identification + assessment + mitigation + acceptance + monitoring + review; critical-to-quality factor identification (data quality + subject safety + scientific validity); proportional + risk-based approach to: monitoring + data management + safety reporting + audit; documented Quality Tolerance Limits (QTLs) per critical-to-quality factor. Risk-based monitoring (RBM): R3 modernised from R2 - centralised + remote + on-site monitoring blend; targeted SDV (critical data only); statistical monitoring of data trends; risk-based site selection; trigger-based escalation. Contract Research Organisation (CRO) oversight: sponsor retains responsibility + accountable; written agreement + scope + transfer of obligations register; CRO qualification + audit + ongoing oversight. Vendor management: investigational product manufacturer + clinical supplies + laboratories + imaging + electronic data capture (EDC) + IWRS/IXRS + central lab + ePRO + wearables; SLA + KPI + qualification + audit + change control + business continuity. Multi-region trial: regulatory submission per region + IND + CTA + protocol amendment per local requirements + global protocol with local addenda. Sponsor data + safety monitoring committee (DSMC) + Data Monitoring Committee (DMC) for adaptive + high-risk trials. Coordinates with ICH Q9 Quality Risk Management + ICH Q10 Pharmaceutical Quality System + FDA Risk-Based Monitoring Guidance + EMA Risk Proportionate Approaches + TransCelerate. ICH E6 + Sponsor + QMS + RBM + CRO + Vendor applies.
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