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-GLOBAL-V4-NOT-AT-SITE

enroll_subject

Fictional attempt CT-ATT-0067. Chain position 67. Proof proof-739a8dbc-68ee-44b3-a228-e499a99dd78e

  1. Proposed. enroll_subject at S04 A on 2026-06-20T12:00:00.000Z. Recorded at 2026-06-20T12:00:00.000Z. Provenance prov:plt001:BND-CT02-GLOBAL-V4-NOT-AT-SITE:CT-ATT-0067.
  2. Evaluated as of 2026-06-20T12:00:00.000Z 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 v3. Credential CT-CRED-ARM, demo-only.

Present: APR-SP-V4, APR-IRB-V4, APR-SIGN-A, ACT-S04-A, CF-03, CON-S04-0001-R, APR-IRB-S04, APR-CON-S04, APR-TRN-S04.

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 · fail · hold

    Site S04 is on v3 at the action time. The action names v4. A global version does not replace the site.

    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 d606316d8cbbae6afe870d1d795fa4d371afec4aa9edabee5e72ef378adada66

Proof hash 71ab775ac158a62af131ee0fa116087e24e3bf3c9becd4d085a0ef1b7af38af3

Input hash 2d0bc92f527d8e570271fd86ce9eb473d97c6db98fc0d5d50be7df8bd1fc7fe1

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0066