It is produced by execution, not after it
The record is a by-product of the run itself. Nothing is assembled retrospectively, so there is no window in which the record and the work can diverge.
This is the object a governed run leaves behind, reproduced in full. It is what an inspector, a quality lead or a statistical reviewer would actually open - not a log file and not a dashboard. Everything below is illustrative: the study, the people and the figures are constructed to show the shape of the record, not to report a real analysis.
Inputs and outputs are hashed at execution. Re-running this analysis reproduces it exactly - or it fails loudly and says why. It will not quietly return a different answer.
| Source | Preparation applied | Classification |
|---|---|---|
| Oncology registry extract1,412,880 patient records | Mapped to common model · de-identified in place | De-identified |
| Sponsor trial dataStudy ONC-2026-014 | Normalized in place · no copy taken | De-identified |
| Licensed terminologyMedDRA, WHODrug | Entitlement verified before resolution | Entitled |
| Control | Requirement | Result |
|---|---|---|
| Analysis authorityCTL-RWE-014 | Method approved for use and within worker clearance | Pass |
| Data residencyCTL-GOV-002 | Execution confined to the sponsor perimeter | Pass |
| Estimand disciplineICH E9(R1) | Estimand declared before execution; sensitivity suite run | Pass |
| License entitlementCTL-DAT-009 | Entitlement valid for every licensed asset resolved | Pass |
StromaOS computed, ranked and drafted. It did not decide. Selection resolved to a named authority inside your organization, recorded with what the signature meant.
The record is a by-product of the run itself. Nothing is assembled retrospectively, so there is no window in which the record and the work can diverge.
Each control line is the result of a check that ran before dispatch. A failed control does not appear as a warning in a report - it stops the work.
“Approved” on its own is not a decision right. The record captures what the named human was approving and under which authority they held it.
A single task, executed end to end under your control set, with the record opened line by line - including the controls that would refuse it.