IRT Commandment #4

Thou Shall Limit IRT to EDC Data Point Integrations

In EDC integrations, less is more.

When sponsors limit and standardize what flows between IRT and EDC, they gain consistency, stability, and predictability.

It has been my experience that when each study starts from scratch with determining what data points to send to EDC, you compromise timelines and quality for both IRT and EDC vendors

Consistency is not a luxury. It’s an accelerator.

Use A Simple, Repeatable Standard

After watching what works (and what doesn’t), I’ve settled on a simple best practice:

Only send what is required to establish:

·       The existence of the participant

·       Their basic identifiers

·       Their randomization or enrollment transaction date

That’s it. By going beyond this, you welcome the death spiral of “system of record” or the “reconciliation loop of doom”. More on that in Commandment #5.

The Payoff

Sponsors who limit integrations don’t lose information — they regain control.

They:

• Standardize implementation

• Simplify vendor coordination

• Reduce review cycles

• Minimize reconciliation

• Scale more easily

Integration discipline pays off everywhere: operations, quality, timelines, and sanity.

I would feel sorry for my IRT brethren who had to struggle with EDC integrations at the start of every study. I never had to answer the question, "What do we need to send?" which meant we never had to worry about whether the IRT to EDC integration would be ready at go-live. It was always ready every single time, without exception, because we never had to struggle with that question.

Profit from my experience

Next up: Commandment 5 — Thou Shall Think Long and Hard About Reconciliation.