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-RECONSENT-HELD

enroll_subject

Fictional attempt CT-ATT-0063. Chain position 63. Proof proof-7a2f3db5-c190-464a-8d33-d29bf29c3455

  1. Proposed. enroll_subject at S01 A on 2026-05-04T10:00:00.000Z. Recorded at 2026-05-04T10:00:00.000Z. Provenance prov:plt001:BND-CT09-RECONSENT-HELD:CT-ATT-0063.
  2. Evaluated as of 2026-05-04T10:00:00.000Z under policy clinical-trial-plt001-v1. Snapshot 8c0075328db2eab4.
  3. HELD. Column mapping condition. Deciding rule CT-09.
  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-V3, APR-IRB-V3, APR-SIGN-A, ACT-S01-A, 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 · fail · hold

    This amendment lists the arm as requiring reconsent. The cited form is the earlier 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 b3132cb90c3faf8687bbab3b23d7ac26c8b14a203f2bc7a75d24c5e5011b53ec

Proof hash 46085495a162cba93158e9ee0ec60250d66075125e610e5b832e864ef87ca229

Input hash c3391cfd1bc34125c51dbdf66b4721af6c1fc4d6bd518efa8718be79d84f46ef

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0062