on ICH E6(R3)
a poem
For twenty years we ticked the boxes,
monitored every line and page,
source-verified each distant fax
as if our rigor lived in rage.
Now R3 asks a deeper question:
what matters most, and why, and where?
Design the quality in from day one,
and spend your vigilance with care.
Critical to quality: name it,
then let proportion guide the hand.
A risk well-weighed is risk well-tamed,
not buried under what we planned.
The site may be a patient's kitchen,
the data flowing, cloud to cloud,
yet governance still keeps its vigil,
and oversight is still avowed.
Sponsors own what vendors carry;
the participant stays at the core.
Less a rulebook, more a compass,
pointing where we should have looked before.
The prose version of all this lives in the plain-language answers.
