Donatella Ballerini — decades inside the Trial Master File; the mind that knows where clinical documentation actually breaks, and what "complete" truly means.
The stance it summoned
The steward — the stance that guards the integrity of the record, and asks who stays accountable when the work runs itself.
The unknown on the table
When AI keeps the eTMF complete and inspection-ready on its own, what is the human still for — in the loop, or on it — and where does accountability finally sit?
The residue
Provisional: a working line between human-in-the-loop and human-on-the-loop for trial-master-file automation — which decisions a machine may close, and which a person must still own.
THE DISCUSSION · WHERE THE ALIVENESS LIVES
Video or podcast · in formation
THE RETICLE · THE RESIDUE YOU READ IT THROUGH
THE ARTEFACT
Not yet — this body problem is still being worked.
The reticle appears when the instance does: the article, the recording, whatever residue this pairing leaves a stranger to read it through.
REFERENCES · THE GROUND IT STANDS ON
—References will be logged when the instance is worked.In formation