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-CT05-PI-DENY

request_unblinded_data

Fictional attempt CT-ATT-0075. Chain position 75. Proof proof-95679c0f-874b-484c-a0dd-49c5df31c080

  1. Proposed. request_unblinded_data at S01 A on 2026-05-06T14:00:00.000Z. Recorded at 2026-05-06T14:00:00.000Z. Provenance prov:plt001:BND-CT05-PI-DENY:CT-ATT-0075.
  2. Evaluated as of 2026-05-06T14:00:00.000Z under policy clinical-trial-plt001-v1. Snapshot 8c0075328db2eab4.
  3. DENIED. Column mapping flag. Deciding rule CT-05.
  4. Downstream. The simulated downstream action was not executed. Only an AUTHORIZED verdict reaches it.

Authority at the action time

Actor human.pi.S01 (site_pi). Agent none. Delegator none. Accountable human Dr. Quinn Adler, a fictional role.

Site protocol version v3. Credential none.

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

Absent: none.

Rules

  • CT-01 · pass

    The named person holds the role on the action at this 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 · not_applicable

    This operation does not distribute or rely on an amendment approval pair.

    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 · fail · deny

    The requested fields include unblinded interim data, and this role is outside the fictional blinding charter. An escalation does not grant the data.

    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 · pass

    IRB approval, the contract, and principal-investigator training are effective.

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

Signature and chain

Previous 36d93b116210f300d94ee197cdfa997dbec9b02467828b630c86773a4f178dce

Proof hash d44cc6b040ac80a55ca055beb7136c8d68bb7246c9e04f9d4896ca619f22df82

Input hash a7f5877eaccfd03122df1e6e3b186a46865044c5a92ae456719705c9b00820da

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0074