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-CT07-ELIGIBILITY

correct_data

Fictional attempt CT-ATT-0087. Chain position 87. Proof proof-c7792067-6c56-4e82-9968-48949512a671

  1. Proposed. correct_data at S01 A on 2026-03-15T10:00:00.000Z. Recorded at 2026-03-15T10:00:00.000Z. Provenance prov:plt001:BND-CT07-ELIGIBILITY:CT-ATT-0087.
  2. Evaluated as of 2026-03-15T10:00:00.000Z under policy clinical-trial-plt001-v1. Snapshot 8c0075328db2eab4.
  3. ESCALATED. Column mapping escalate. Deciding rule CT-07.
  4. Downstream. The simulated downstream action was not executed. Only an AUTHORIZED verdict reaches it.

Authority at the action time

Actor agent.reconciliation (data_manager). Agent agent.reconciliation. Delegator human.data_manager. Accountable human Noah Kim, a fictional role.

Site protocol version v2. Credential CT-CRED-RECON, demo-only.

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

Absent: none.

Escalation target: Dr. Priya Shah (sac). This does not grant the action.

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 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 · fail · escalate

    Endpoint, eligibility, and safety corrections wait for a separate human review.

    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 e079a29dc8689bbe5a39e310322807b25248c745278c6336b0b9676eb99a4403

Proof hash 04ee620f2a56f87c0d72994523c08ddd362c99774d808db1d18f267f88aad57e

Input hash b5c890a0f0521b58da4c7a133663c0ccad247448c0f0acd27eba552d480f7016

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0086