You can delegate the work, not the responsibility
A sponsor can transfer trial duties to a CRO or other provider, but remains responsible for the quality and integrity of the trial and its data. Regulators expect the transfer to be documented, and your oversight of it to be planned and evidenced. That is why an outsourced sponsor's procedures look different: fewer on doing the work, more on controlling it.
The oversight procedures you need
- Service provider selection and management: qualifying providers before you contract, and overseeing them throughout.
- CRO governance: project management, governance meetings, escalation routes and the transfer of obligations.
- Risk and quality management: your own risk assessment of the trial, not only the CRO's.
- Safety oversight: how you review safety data and make sponsor decisions, even when the CRO runs pharmacovigilance.
- Trial master file: the TMF belongs to the sponsor, wherever it is held.
- Quality events and CAPA: how issues found at the CRO are escalated to you and closed.
- Regulatory and ethics submissions: oversight of what is submitted in your name.
- Inspection readiness: hosting inspections of your oversight, which is what an inspector of an outsourced sponsor examines most closely.
- Training: evidence your own team is trained for their oversight roles.
Working to the CRO's SOPs
It is normal for delegated work to be done under the CRO's procedures. Record which of their SOPs apply to which activities, usually in the contract or a responsibilities matrix, and review them before work starts. Your SOPs then govern how you oversee that work. See whether you need your own SOPs if you use a CRO.
Common gaps
- No documented qualification of the CRO before contracting
- Oversight that happens but is not recorded
- TMF gaps that only surface at handover or inspection
- No agreed route for escalating issues to the sponsor
Our SOP library includes the oversight procedures, and you can take only those. For deciding what to hand over in the first place, see what to outsource to a CRO.