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-DIST-V2-PASS

distribute_amendment

Fictional attempt CT-ATT-0013. Chain position 13. Proof proof-fc38fbae-4659-4de5-8bac-e215d1cde70a

  1. Proposed. distribute_amendment at S01 on 2026-02-26T12:00:00.000Z. Recorded at 2026-02-26T12:00:00.000Z. Provenance prov:plt001:SCN-DIST-V2-PASS:CT-ATT-0013.
  2. Evaluated as of 2026-02-26T12:00:00.000Z 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 agent.amendment (platform_operator). Agent agent.amendment. Delegator human.operator. Accountable human Avery Quinn, a fictional role.

Site protocol version v1. Credential CT-CRED-AMD, demo-only.

Present: APR-SP-V2, APR-IRB-V2, APR-IRB-S01, APR-CON-S01, APR-TRN-S01.

Absent: none.

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 · pass

    Sponsor and Central IRB approvals are both effective.

    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 · pass

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

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

Signature and chain

Previous 666cf1a622b497a9156f67dd2831c1006282782ed95a295a498971ff47d1d3c1

Proof hash 34a2ac68821cd1180d7be9899e0d4e7a7715fe9c0efc3faa8dc9469faccbf848

Input hash 5e8d69376b8fb585d45e8de8641609271db3649035572300acff0f054347d61e

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0012