IRT Commandment #11

Thou Shall Develop & Enforce Standards, Until It Is Time To Break Them

I can’t believe I am writing about standards in IRT. It’s the kind of topic that makes me want to yawn. It feels so played out and obvious. It is on the agenda of every IRT conference.

But let’s look at them from a different angle: why we need them and how to avoid making them immutable or a barrier.

The best way to achieve efficiency, repeatability, and quality in IRT is through the use of standards.

If you are a small company taking a transactional approach, it is understandable for standards to not be high on your list of imperatives. But for organizations pursuing an enterprise approach, standards are essential.

Why Standards Matter

Standards work best, and perhaps only, when they are aligned with upstream and downstream processes, and with the cross-functional teams that support them.

When they are implemented well, standards create consistency across studies, reduce variability, and allow organizations to scale without reinventing processes each time.

They also serve as a bulwark against rogue clinical teams that argue that their study is different because “this is the most important study in the company.” I used to hear that phrase often.

Standards help organizations resist that pull toward unnecessary customization.

Knowing When to Break Them

But standards are not meant to be rigid rules that ignore reality. I often say that we are doing research, and that means being dynamic in the face of new data.

There will be times when breaking a standard is necessary. This may be driven by a unique study design, an operational constraint, or a situation that cannot be reasonably addressed within existing frameworks.

They should be intentional, well thought out, and agreed upon by the appropriate cross-functional stakeholders.

Breaking a standard should never be casual. It should be deliberate.

A Shared Responsibility

When the decision is made to break a standard, vendors must be prepared to support that decision. They should, of course, remind the sponsor of their standard, but be ready to flex with appropriate justification and leadership acknowledgement.

Standards are a tool to serve the study, not a mechanism to prevent thoughtful adaptation when circumstances require it.

The goal is not to enforce standards for their own sake. The goal is to create a stable foundation that supports thoughtful flexibility when needed.

The Takeaway

Standards bring order, consistency, and scalability to IRT.

But maturity is knowing when adherence strengthens the study and when thoughtful deviation is the better path.

Develop standards. Enforce them. Respect them. And when the time comes, be prepared to break them for the right reasons.