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-ENROLL-S05-CONTROL-30

enroll_subject

Fictional attempt CT-ATT-0056. Chain position 56. Proof proof-2995c8fc-eeca-4bc0-b180-b3650d986f5d

  1. Proposed. enroll_subject at S05 CONTROL on 2026-03-02T09:00:00.000Z. Recorded at 2026-03-02T09:00:00.000Z. Provenance prov:plt001:SCN-ENROLL-S05-CONTROL-30:CT-ATT-0056.
  2. Evaluated as of 2026-03-02T09:00:00.000Z under policy clinical-trial-plt001-v1. Snapshot 8c0075328db2eab4.
  3. AUTHORIZED. Column mapping approve. No rule blocked the action.
  4. Downstream. Synthetic downstream action recorded inside this demonstration. No external system was contacted.

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 v1. Credential CT-CRED-ARM, demo-only.

Present: APR-SP-V1, APR-IRB-V1, APR-SIGN-CTL, ACT-S05-CONTROL, CF-01, CON-S05-0003, APR-IRB-S05, APR-CON-S05, APR-TRN-S05.

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 v1, which is the version effective at S05.

    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 · pass

    Enrollment sits under an independent arm activation that is already effective.

    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 · pass

    The IRB-approved form and the documented subject consent fit this action. Reconsent was required only where the amendment lists the arm.

    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 29bceb5d50220070dbb801c0beecc5e47ce81021b9c05170bc67b2e618e0ebaf

Proof hash f0cb821de2a18babf3b5a4cc16eebfac38e5493d1de2ccbba984a04a503755dd

Input hash 9be9d1536c03124063e11dffa37f52dc5720c728210c2ca8319c88bc5a9ca5e6

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0055