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-LATE-SAE

Late, misrouted serious event

Fictional attempt CT-ATT-0004. Chain position 4. Proof proof-a70f417e-9dd7-4ba8-b3de-33283d5743c8

  1. Proposed. report_safety at S02 A on 2026-04-03T14:00:00.000Z. Recorded at 2026-04-03T14:06:00.000Z. Provenance prov:plt001:SCN-LATE-SAE:CT-ATT-0004.
  2. Evaluated as of 2026-04-03T14:00:00.000Z under policy clinical-trial-plt001-v1. Snapshot 8c0075328db2eab4.
  3. ESCALATED. Column mapping escalate. Deciding rule CT-08.
  4. Downstream. The simulated downstream action was not executed. Only an AUTHORIZED verdict reaches it.

Authority at the action time

Actor agent.safety (medical_monitor). Agent agent.safety. Delegator human.monitor. Accountable human Dr. Owen Blake, a fictional role.

Site protocol version v2. Credential CT-CRED-SAFETY, demo-only.

Present: APR-IRB-S02, APR-CON-S02, APR-TRN-S02.

Absent: none.

Escalation target: Dr. Owen Blake (medical_monitor). 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 v2, which is the version effective at S02.

    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 · fail · escalate

    The fictional protocol routes a serious event to the medical monitor within 24 hours of site awareness. This report is late or misrouted and escalates. 21 CFR 312.32 remains the sponsor's separate IND duty; it is not this agent's deadline.

    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 9fbda342d4aebf900757a2740b6e4e7725aeac26de7d8815346a8ccd66abeb8c

Proof hash c64219a59fc18c475f8580d64d5ea6ba1040511a04cb897a70f183c18571243c

Input hash e9fab17b24090c9d522385ee1a2f5ee2af2aee00a76481c882a1b58b5b12372e

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0003