Deep dive — methodology
Counterparty-question rehearsal — the 5-decision reproducibility drill
Every $499 Snapshot samples five AI-driven decisions from a target-day and reproduces them defensibly. Not because you need them all today — because the discipline of reproducing five proves the discipline could reproduce any of them tomorrow, whether the question comes from FDA BIMO, EMA scientific advice, ICH E6(R3) essential-documents review, DSMB, or IRB continuing-review.
The prompt the rehearsal answers
"Reproduce this AI-generated eligibility decision from Day 47 including the candidate's primary diagnosis, comorbidity profile at screening, inclusion/exclusion criteria state, model version, eligibility-exclusion score, and lane routed — as a defensible record we can produce for FDA Bioresearch Monitoring Program inspection, EMA scientific advice, ICH E6(R3) essential-documents review, DSMB safety-signal investigation, or IRB continuing-review response."
The counterparty question — identical shape whether it comes from FDA, EMA, ICH, DSMB, or IRB
Sample screening decisions from Day 47
| Screening ID | Score | Lane | Model version | Decision hash |
|---|
| SCR-002534 | 74.67 | Ineligible / Exclude | trial-eligibility-classifier-v2.8.1 | tec-002534 |
| SCR-002533 | 30.47 | Eligible / Enroll | trial-eligibility-classifier-v2.8.1 | tec-002533 |
| SCR-002532 | 43.12 | Further Screening / Investigator Review | trial-eligibility-classifier-v2.8.1 | tec-002532 |
| SCR-002531 | 66.15 | Ineligible / Exclude | trial-eligibility-classifier-v2.8.1 | tec-002531 |
| SCR-002525 | 74.05 | Ineligible / Exclude | trial-eligibility-classifier-v2.8.1 | tec-002525 |
What "defensibly reproduced" means
- Model version pinned. Not "the current model" — the exact classifier build deployed at decision-time.
- Input snapshot bound. Primary diagnosis + ECOG performance status + prior-therapy lines + comorbidity count + days-to-randomization-target exactly as they were when the AI scored the screening.
- Decision hash bound. Cryptographic hash tying the input to the output — makes tampering detectable.
- Retention pipeline independent. The retention system that holds the records is not the production model itself — independence of the record from the actor being recorded.
What the rehearsal proves
All 5 sampled Day-47 screening decisions reproduced with defensible-records match. Model version pinned, decision hash cryptographically bound, input data retained via decision-provenance record. If FDA / EMA / DSMB / IRB requests any of the ~4,969 screenings in the audit period, the same reproduction procedure applies.
Retention horizon
- 21 CFR §11.10(c): electronic-records retention runs at least as long as the underlying subject records
- FDA pivotal-trial record-retention horizon: typically 15 years post-NDA/BLA approval; sponsor SOPs frequently extend
- ICH E6(R3) essential-documents duty: retention through trial conclusion + regional record-retention regime
- Litigation hold: preserves through matter conclusion, may extend original horizon
The rehearsal record is not a one-time exhibit — it is proof that the retention discipline is operational.
Why 5, not 500
Reproducing 500 decisions on request is a discovery-response exercise, appropriately triggered by a specific legal or regulatory process. Reproducing 5 sample decisions at Snapshot time is a discipline-test: it validates that the retention pipeline works, without spending the audit budget on record production nobody has asked for yet.
$499 Snapshot. 3 business days.
Same 5-decision reproducibility drill on your sponsor's actual AI surface + counterparty-question rehearsal record.
Buy $499