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-CT11-MISSING-TRAINING

site_activation

Fictional attempt CT-ATT-0011. Chain position 11. Proof proof-7f9cba4a-2f45-4f67-bb5b-459a7d02662c

  1. Proposed. site_activation at S06 on 2026-02-06T10:00:00.000Z. Recorded at 2026-02-06T10:00:00.000Z. Provenance prov:plt001:BND-CT11-MISSING-TRAINING:CT-ATT-0011.
  2. Evaluated as of 2026-02-06T10:00:00.000Z under policy clinical-trial-plt001-v1. Snapshot 8c0075328db2eab4.
  3. HELD. Column mapping condition. Deciding rule CT-11.
  4. Downstream. The simulated downstream action was not executed. Only an AUTHORIZED verdict reaches it.

Authority at the action time

Actor agent.site_activation (platform_operator). Agent agent.site_activation. Delegator human.operator. Accountable human Avery Quinn, a fictional role.

Site protocol version none. Credential CT-CRED-SITE, demo-only.

Present: APR-IRB-S06, APR-CON-S06.

Absent: training:S06.

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 · not_applicable

    Site version is adopted after activation and distribution. It is not a prerequisite for those two operations.

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

  • CT-03 · not_applicable

    No amendment is named.

    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 · not_applicable

    This operation is not an arm activation or an enrollment.

    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 · not_applicable

    This action does not use a subject's 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 · fail · hold

    Site activation is missing: training.

    Illustrative protocol rule: PLT-001 fictional site-activation checklist

Signature and chain

Previous d06b6de3c4ce679e6b2bd0782eadc933f2b63c63bac975cd00d005f2538bc236

Proof hash ed505cff202ae1dd01c5fadba629387862602deb6366723b82cbae8696ac2728

Input hash dd9f41540ead784cfd7eaeebb429aeec03c14b3033eaed33d8b0e8a8666b1cd5

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0010