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-CT09-NO-AUTO-RECONSENT

enroll_subject

Fictional attempt CT-ATT-0065. Chain position 65. Proof proof-253e98cc-4120-47f0-a9a6-95ed9dd362c2

  1. Proposed. enroll_subject at S01 B on 2026-05-04T12:00:00.000Z. Recorded at 2026-05-04T12:00:00.000Z. Provenance prov:plt001:BND-CT09-NO-AUTO-RECONSENT:CT-ATT-0065.
  2. Evaluated as of 2026-05-04T12:00:00.000Z 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 v3. Credential CT-CRED-ARM, demo-only.

Present: APR-SP-V3, APR-IRB-V3, APR-SIGN-B, ACT-S01-B, CF-01, CON-S01-0005, 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 · 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 143044bb9a47a679caabf65e651ec680e6768328a59a1bd4fe43da659b4a116b

Proof hash 4349d1efc096fbcaf7d1d4a3edcc32a18e77dcbc27969c630bd2ce8f02010692

Input hash 189511e852007f4161f0437ac924bb2832063d736a68f601883f8f8e30c0126d

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0064