When a CRO has assumed trial-related duties, to whom do references to the sponsor apply?

• A. Only to the Sponsor
• B. To the Sponsor and CRO Equally
• C. To the CRO to the Extent It Has Assumed the Duties
• D. To Neither

Answer: (C)

Delegation of trial-related duties to a CRO means the sponsor can assign specific responsibilities to the CRO under a contract. When the CRO has taken on those duties, references to the sponsor in trial documents, regulatory submissions, and communications apply to the CRO to the extent it has assumed them. The sponsor still holds ultimate accountability for the trial, but the CRO acts on the sponsor’s behalf for the tasks it performs. If a duty hasn’t been delegated, references would apply to the sponsor. So, the sponsor’s references apply to the CRO to the extent it has assumed the duties.