Regulatory rationale should live at the field level, not the document level

ICH E9 §3.5 doesn’t apply to your whole protocol — it applies to a specific decision. Your tooling should know that.

Every protocol author has had the experience of justifying a design choice to a reviewer and reaching for a 200-page PDF. This is wasted effort: the guidance documents are structured — by section, by sub-section, by decision type.

Linking guidance at the field level isn’t a nice-to-have. It’s the difference between defensible-at-audit and hope-this-holds.

Placeholder body — edit content.js → resources.posts.


By Trelice team
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