Synthetic demonstration. No real patient data and no clinical operations. This replay does not connect to an EDC, CTMS, IRB, sponsor, or patient system.

ICH E6(R3), 21 CFR Part 11, and 21 CFR 312.32 are informative references for this illustrative policy. They are not certifications and not a claim of regulatory approval, validated GxP use, or a real trial integration. Part 11 suitability needs controls beyond a demonstration signature and hash chain. No clinical recommendation is made.

Back to the replay

SCN-CROSS-ARM-EXPORT

Cross-arm export

Fictional attempt CT-ATT-0005. Chain position 5. Proof proof-16cdaf03-e1e6-454f-84c4-e4a5970b19c8

  1. Proposed. export_data at S01 B on 2026-05-12T16:00:00.000Z. Recorded at 2026-05-12T16:01:00.000Z. Provenance prov:plt001:SCN-CROSS-ARM-EXPORT:CT-ATT-0005.
  2. Evaluated as of 2026-05-12T16:00:00.000Z under policy clinical-trial-plt001-v1. Snapshot 8c0075328db2eab4.
  3. DENIED. Column mapping flag. Deciding rule CT-10.
  4. Downstream. The simulated downstream action was not executed. Only an AUTHORIZED verdict reaches it.

Authority at the action time

Actor agent.export (data_manager). Agent agent.export. Delegator human.data_manager. Accountable human Noah Kim, a fictional role.

Site protocol version v3. Credential CT-CRED-EXPORT, demo-only.

Present: DUA-A, APR-IRB-S01, APR-CON-S01, APR-TRN-S01.

Absent: none.

Rules

  • CT-01 · pass

    The demo-only credential is in force for this agent, scope, and time.

    Illustrative protocol rule: PLT-001 fictional delegation schedule, section 4

  • CT-02 · pass

    The action names v3, which is the version effective at S01.

    Illustrative protocol rule: PLT-001 fictional protocol, section 3, site-version control

  • CT-03 · not_applicable

    This operation does not distribute or rely on an amendment approval pair.

    Illustrative protocol rule: PLT-001 fictional amendment procedure. ICH E6(R3) is context for why amendments are approved before use, not a certification.

  • CT-04 · not_applicable

    This operation is not an arm activation or an enrollment.

    Illustrative protocol rule: PLT-001 fictional arm-activation charter

  • CT-05 · not_applicable

    No unblinded field was requested.

    Illustrative protocol rule: PLT-001 fictional blinding charter, section 7

  • CT-06 · not_applicable

    This operation is not an adaptation.

    Illustrative protocol rule: PLT-001 fictional adaptation charter

  • CT-07 · not_applicable

    This operation does not correct a record.

    Illustrative protocol rule: PLT-001 fictional data-management plan

  • CT-08 · not_applicable

    This operation is not a safety report.

    Regulatory context: PLT-001 fictional safety-routing window. 21 CFR 312.32 cited as regulatory context, not as an agent clock.

  • CT-09 · not_applicable

    This action does not use a subject's consent.

    Illustrative protocol rule: PLT-001 fictional consent plan

  • CT-10 · fail · deny

    The recipient's agreement does not cover this arm. The export is denied and is not executed.

    Illustrative protocol rule: PLT-001 fictional data-use agreements

  • CT-11 · pass

    IRB approval, the contract, and principal-investigator training are effective.

    Illustrative protocol rule: PLT-001 fictional site-activation checklist

Signature and chain

Previous c64219a59fc18c475f8580d64d5ea6ba1040511a04cb897a70f183c18571243c

Proof hash 9bd6c91412646fcc4ce3c65a725587a21e41aa091892bf3189c379a2781f4f73

Input hash 1f9620dbc06de93e8eced4ae49ef8f5c1fdb8ff43b27475407432a08c158b2fb

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0004