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-DSMB-PASS

request_unblinded_data

Fictional attempt CT-ATT-0074. Chain position 74. Proof proof-4fe1ea53-d04a-4972-8b57-0186a275917d

  1. Proposed. request_unblinded_data at S01 A on 2026-05-06T13:00:00.000Z. Recorded at 2026-05-06T13:00:00.000Z. Provenance prov:plt001:BND-CT05-DSMB-PASS:CT-ATT-0074.
  2. Evaluated as of 2026-05-06T13:00:00.000Z under policy clinical-trial-plt001-v1. Snapshot 8c0075328db2eab4.
  3. AUTHORIZED. Column mapping approve. No rule blocked the action.
  4. Downstream. Synthetic downstream action recorded inside this demonstration. No external system was contacted.

Authority at the action time

Actor human.dsmb (dsmb). Agent none. Delegator none. Accountable human Dr. Lena Okonkwo, 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 · pass

    The role is named in the fictional blinding charter for these fields.

    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 10658db554d5b6e00224c849d56216e694a377833b8c43465a5410083791af4a

Proof hash 36d93b116210f300d94ee197cdfa997dbec9b02467828b630c86773a4f178dce

Input hash fc4b61f7c6eff42e7b89a920d7f3c7bb3f74067a2fd25e6df6a255e94d9d6745

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0073