Avoiding The Gotchas: RTSM Build Tips From A Seasoned PM

Even well‑written protocols can hide small details that snowball into major operational challenges. This clip takes a closer look at why seemingly simple criteria or routine data points can create far more friction than the “big” design decisions teams usually focus on.

The discussion highlights how overlooked elements — like a single inclusion criterion or a lab value flowing from EDC — can derail workflows when integrations aren’t planned early or clearly. It also underscores why vague or open‑ended statements in a protocol become pain points later, especially when they shape criteria, stratification factors, or visit schedules.

A key takeaway centers on timing: the sooner operational teams can weigh in, the smoother the RTSM build becomes. Early input doesn’t have to rewrite the protocol, but it often prevents avoidable rework and the downstream headaches that come from unclear definitions.

This clip offers a practical look at where study design and system design intersect—and why the smallest details deserve just as much attention as the complex ones.