Proving Your TMF Has Not Changed: A Post-Export, Zero-Custody Verification Model Validated in Blinded Multi-Operator Conditions

About this session

Part of Session 6, Track E: TMF Validation and Governance (Chair: Lisa Mulcahy, Mulcahy Consulting).

At post-export TMF custody boundaries (e.g., submission, archival, or CRO handoff), integrity is typically demonstrated through vendor attestations, re-exports, or manual reconciliation. These methods indicate what should have happened rather than what occurred at the byte level.
We evaluated a system-independent, zero-custody verification model for post-export TMF evidence. In a blinded, multi-operator study of 230,253 evidence files and 21,966 evidence-set fingerprints, tamper detection achieved 100% sensitivity (879/879 altered items detected) with no false positives (229,374/229,374 unaltered items confirmed). Mean verification time was 0.076 seconds per file and scaled with tamper burden (r=0.91, p<0.0001), but not corpus size for proof-of-unchanged verification (r=-0.01, p=0.93).
The model runs locally within the custodian’s environment, with no data or identifiers leaving the institution. Hash-only export packets enable independent offline re-verification without vendor access, supporting ICH E6(R3) inspection readiness.

Speaker

• FT

  Fernando Telles

  Cardiovascular Diagnostic Audit & AI

  Speaker