Use ICH E6 sponsor oversight principles to escalate a CRO data-quality issue without outsourcing accountability.
CRO PM CP Clinical operations partner 1 Impact 2 Ownership 3 Control The signal Interim data cut Endpoint timestamps are missing and the CRO points to a vendor issue. The sponsor must own data reliability decisions even when work is outsourced. Framework 60 sec Impact + Ownership + Interim Control Ask for the affected data, accountable fix, and decision controls while the fix is pending. Delegation does not remove sponsor oversight.
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