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

BND-CT04-PENDING

activate_arm

Fictional attempt CT-ATT-0023. Chain position 23. Proof proof-12c7b09a-48ab-4f9c-94e3-75447ab28d01

  1. Proposed. activate_arm at S03 C on 2026-04-29T15:00:00.000Z. Recorded at 2026-04-29T15:00:00.000Z. Provenance prov:plt001:BND-CT04-PENDING:CT-ATT-0023.
  2. Evaluated as of 2026-04-29T15:00:00.000Z under policy clinical-trial-plt001-v1. Snapshot 8c0075328db2eab4.
  3. ESCALATED. Column mapping escalate. Deciding rule CT-04.
  4. Downstream. The simulated downstream action was not executed. Only an AUTHORIZED verdict reaches it.

Authority at the action time

Actor agent.arm_onboarding (platform_operator). Agent agent.arm_onboarding. Delegator human.operator. Accountable human Avery Quinn, a fictional role.

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

Present: APR-SP-V3, APR-IRB-V3, APR-SIGN-C, APR-IRB-S03, APR-CON-S03, APR-TRN-S03.

Absent: none.

Escalation target: Riley Chen (sponsor). This does not grant the action.

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 S03.

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

  • CT-03 · pass

    Sponsor and Central IRB approvals are both effective.

    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 · fail · escalate

    A named human has not decided. The action waits for that person.

    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 · not_applicable

    This operation is not an export.

    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 d50e3873547926e102b19bde4f0bbee25d6c7ba59d534f19c2d08629320aa4de

Proof hash ee0123a9afcfe95b7b429db1dad642f41f76150485625210157fca099ac30617

Input hash 3f11fc46c6f19332c8ccfe935a9ed3cb39adbe67ca75ad0715f48fc8e0dd7c58

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0022