IRT Commandment #7

IRT Provider Shall Not Develop Scripts For Or Perform Sponsor UAT

Even an IRT provider you trust, and who has provided good service, may still have an unconscious bias or built-in conflict.

That is not an accusation. It is simply human nature.

For that reason, I have always recommended that sponsors either perform UAT themselves or outsource it to a qualified third-party expert. That recommendation has not changed, regardless of which side of the sponsor–provider equation I have been on.

UAT is not just a technical exercise. It is a confirmation that the system is fit for purpose. That accountability belongs with the sponsor.

Why Independence Matters

UAT findings are often treated as a KPI for vendors. That creates a business incentive to fix an issue quickly and keep it from showing up as an official finding.

That does not mean vendors act in bad faith. It means incentives shape behavior.

You will sometimes hear vendors point out that CROs or third parties can have their own incentives as well. In some cases, more findings can be seen as a way to demonstrate value.

That observation is not wrong. But it is also not the real issue.

Do not let that argument distract from the much larger and more important conflict of interest, which is having the system builder test and approve their own work.

No testing model is perfectly neutral. But independent testing is still the right trade-off.

One bias favors minimizing findings. The other may favor surfacing more than strictly necessary. Neither is perfect, but only one preserves independence.

And independence is the point.

The goal of UAT is not to minimize findings or to maximize them. It is to surface real issues, document them, address them, and confirm that the system preforms as intended.

A Consistent Position

My opinion on this has never changed.

Whether I was sitting on the sponsor side or the provider side, my recommendation has always been the same, often to the chagrin of some past employers.

That separation is not adversarial. It is good governance.

Regulatory Perspective

This is not just personal preference.
The EMA has stated it clearly in their reflection paper:

“The sponsor should assure themselves through UAT of the suitability of each system. It is expected that the sponsor will write their own test scripts for testing the system.”

That guidance exists for a reason.

Accountability for system suitability cannot be outsourced.

Read more here Sponsors & UAT with Poxy Clinical

The Takeaway

Sponsors own UAT.

Vendors support the process. They should not control it.

That boundary protects everyone.