What is adequate sponsor oversight when outsourcing?

According to the updated ICH GCP, section 5.2.2:

The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).

The challenging question is how to ensure adequate oversight?

During inspections, the inspectors are increasingly assessing the sponsor’s oversight of the CROs. The inspectors often look at the following areas:

• Selection and qualification of the CRO
• An agreement that defines the tasks which have been delegated to the CRO
• Ongoing oversight of the CRO during the clinical trial

Ongoing oversight of the CRO can be varied from a hands-off approach to micromanagement. The challenge is to find a balance where the sponsor has sufficient data to be confident that the CRO services are in accordance with the agreements.

How to ensure adequate oversight?

It is highly recommended, that the sponsor should have at least one clinical project manager (CPM) for all clinical trial activities. The CPM(s) can build engagement with the CRO team by attending and managing project team meetings. The CPM(s) should also ensure that the sponsor team members are always involved in all relevant aspects of the trial according to their role. Clear communication and effective coordination will ensure the best results.

Another recommendation is to have a proactive quality risk management. I.e. the sponsor should define and assess proactively what are critical data and processes associated with the protocol. Based on this, a risk management plan should be developed to support the monitoring strategy. The risk management plan should include trial specific risks, grading of each risk and mitigation of risks.

This proactive approach will ensure that the CRO is not just informing the sponsor of issues once they have occurred, but the CRO is also actively engaged in preventing the issues from occurring.

Here are some examples of sponsor oversight activities:

• Review and approval of plans (e.g. communication plan, monitoring plan, protocol deviation categorisation)
• Review of site qualification (e.g. investigator CV)
• Involvement in training of CRO staff and site staff
• Review of deviations and monitoring reports
• Review of data
• Close monitoring of safety data
• Regular team meetings

For risk management to be effective, it should include all functions involved in the trial —from site selection until preparation of the clinical trial report. For example, data reviewed by data management team should be communicated to the monitors and vice versa to ensure that the data are handled correctly during the trial.

Level of oversight

The level of oversight is higher with complex trials, such as complex trial design, complex procedure, large amount of data  – large number of subjects  –  paediatric, elderly or seriously ill subject population.

A trial oversight plan should be prepared to describe the oversight activities and frequency.

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