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-CT02-ARM-C-TOO-EARLY

enroll_subject

Fictional attempt CT-ATT-0066. Chain position 66. Proof proof-b8a01030-ce87-4f90-92b7-66ee2efdf747

  1. Proposed. enroll_subject at S01 C on 2026-04-20T12:00:00.000Z. Recorded at 2026-04-20T12:00:00.000Z. Provenance prov:plt001:BND-CT02-ARM-C-TOO-EARLY:CT-ATT-0066.
  2. Evaluated as of 2026-04-20T12:00:00.000Z under policy clinical-trial-plt001-v1. Snapshot 8c0075328db2eab4.
  3. HELD. Column mapping condition. Deciding rule CT-02.
  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 v2. Credential CT-CRED-ARM, demo-only.

Present: APR-SP-V3, APR-IRB-S01, APR-CON-S01, APR-TRN-S01.

Absent: central_irb:v3.

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 · fail · hold

    Site S01 is on v2 at the action time. The action names v3. A global version does not replace the site.

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

  • CT-03 · fail · hold

    The sponsor approval and the Central IRB approval are not both effective for this amendment at the action time.

    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 · hold

    The protocol version at this site does not include that arm.

    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 · fail · hold

    The consent form is not effective under an IRB approval at the action time.

    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 4349d1efc096fbcaf7d1d4a3edcc32a18e77dcbc27969c630bd2ce8f02010692

Proof hash d606316d8cbbae6afe870d1d795fa4d371afec4aa9edabee5e72ef378adada66

Input hash cddac9e715d69729ceaefd47e2824844dd12c957de1e761436d8b649eace7866

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0065