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

SCN-ESCALATION-RESOLUTION

correct_data

Fictional attempt CT-ATT-0106. Chain position 106. Proof proof-46228bf1-400b-4137-aecc-fa85eddd8b70

  1. Proposed. correct_data at S01 A on 2026-03-20T15:00:00.000Z. Recorded at 2026-03-20T15:00:00.000Z. Provenance prov:plt001:SCN-ESCALATION-RESOLUTION:CT-ATT-0106.
  2. Evaluated as of 2026-03-20T15:00:00.000Z 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.sac (sac). Agent none. Delegator none. Accountable human Dr. Priya Shah, a fictional role.

Site protocol version v2. 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 v2, 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 · 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 · pass

    The correction is an unlocked edit check inside the fictional data-management plan.

    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 de0ca64c90f49ab4ed31034ada194dda0b17d0be78150dd194715ba2566195c6

Proof hash ad689239ba3dd6821e995a7a1fb35ec1b8977669c5a88ea8ac5d371c56c31cbc

Input hash 43966b831b16c56efbb8a186974c3100927cbb2ec7d24d603e2c501ab1035b08

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0105