IRT Commandment #1

The IRT system is to serve only its primary purposes

Every good belief system starts with a first commandment — and in IRT, this is where most heresies begin. Before we debate integrations, reconciliation, or user experience, let’s start simple: what is IRT actually for?

The primary purpose of an IRT system

·       enroll/randomize patients

·       provide a system to manage IMP from release through to return/destruction,

·       mechanism to unblind patients.

It provides some great downstream benefits like reporting for project management, but those are by-products not primary responsibilities.

Too often an IRT system is viewed as a place to collect data that belongs to the EDC, a mechanism to control site activity, or even a tool for sponsor approval workflows.

The urge to collect data in IRT is a reflexive response to the problem that sites delay data entry into the EDC system. It is the number one reason that sponsors give for adding data collection to the IRT. Followed closely by the desire to manage adherence to the protocol. My perspective is that one should channel their inner Six Sigma expert and address the root cause, which is site’s EDC delay, and the inherent tension between scientific study and real-world circumstances.

Making your IRT a replacement or EDC supplement leads to downstream issues like

·       longer development timelines

·       additional validations

·       reconciliation nightmares

·       site frustration    

A friend of mine — let’s call him Big Al — works at a large pharma company and insists on using the term RTSM instead of IRT.

Why? Primarily to fend off colleagues who want to “put more in the IRT.”
He believes the broader acronym clarifies purpose. I disagree on semantics (after all, “Excel” isn’t “accounting”), but I understand his defense completely. He’s trying to protect the boundaries that make IRT effective.

When you perform UAT, you confirm that your system was built for purpose.
Design your IRT the same way — for its primary purposes only.

Leave the rest where it belongs.

Next up: Commandment 2 — Thou Shall Not Defer Functionality.