Sponsor, CRO, and Who Holds the Duty

Part of Clinical Project Management (PM) Training: What a Project Manager Owns.

About 2 minutes. Free, in your language, no account needed.

Transferring work is not transferring responsibility

A sponsor may contract a CRO to run any or all trial activities. ICH E6(R3) is explicit that the transfer must be written down, and equally explicit that the sponsor keeps responsibility for the quality and integrity of the trial data regardless of who performs the work.

So a CRO can do the monitoring. The sponsor still answers for whether the monitoring happened and whether it was any good.

The transfer of responsibilities document

Whatever it is called locally, there is a document that lists each activity and says who performs it. It matters more than the contract, because it is the artifact an inspector reads to establish who was supposed to do what.

Two failures are common and both are yours to prevent.

Gaps. An activity nobody is assigned. Safety reconciliation is the classic one: the CRO assumes the sponsor's pharmacovigilance group does it, the sponsor assumes the CRO does it as part of data management, and it goes undone until a regulator asks.

Overlaps that are not agreed. Two parties both believe they own a task. Work is duplicated, the versions diverge, and the file ends up with two answers to one question.

Reading it as an inspector would

Take one activity that has gone wrong on a trial you know. Find it in the transfer document. Can you tell, from that document alone, who should have done it?

If you cannot, neither can an inspector, and the answer will default to the sponsor.

Oversight is evidenced, not asserted

Saying you oversaw a CRO is not oversight. Minutes of governance meetings, issue logs with dates and outcomes, reviewed metrics, and a record of what you did when something was off are oversight. If none of that exists, the oversight did not happen in any way that can be demonstrated.