Demo University

Guided Notes

Vendor & CRO Oversight

Sponsor accountability, selecting and qualifying vendors, contracts and scope, oversight plans, KPIs, issue escalation and governance for outsourced data management.

Sponsor accountability

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Sponsors may outsource data management, EDC, labs, eCOA and more — but ICH E6 is clear: the sponsor remains ultimately responsible for trial data quality and integrity. So sponsors need active oversight, not just signed contracts.

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