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-ENROLL-S02-CONTROL-11

enroll_subject

Fictional attempt CT-ATT-0037. Chain position 37. Proof proof-37967941-91d1-4c17-a671-bfa9577aeb9a

  1. Proposed. enroll_subject at S02 CONTROL on 2026-02-20T09:00:00.000Z. Recorded at 2026-02-20T09:00:00.000Z. Provenance prov:plt001:SCN-ENROLL-S02-CONTROL-11:CT-ATT-0037.
  2. Evaluated as of 2026-02-20T09:00:00.000Z 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.arm_onboarding (platform_operator). Agent agent.arm_onboarding. Delegator human.operator. Accountable human Avery Quinn, a fictional role.

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

Present: APR-SP-V1, APR-IRB-V1, APR-SIGN-CTL, ACT-S02-CONTROL, CF-01, CON-S02-0004, APR-IRB-S02, APR-CON-S02, APR-TRN-S02.

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 · pass

    The action names v1, which is the version effective at S02.

    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 · pass

    Enrollment sits under an independent arm activation that is already effective.

    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 · pass

    The IRB-approved form and the documented subject consent fit this action. Reconsent was required only where the amendment lists the arm.

    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 82d15111f2fea0bc656a5da71d598430941d395451b91e706eb81082801665a4

Proof hash e7d26f57c5aab43d507b2029f51cbcef3d33ccbe4814f9bc6297e5a903234a0f

Input hash 615d18a0a4acdf7429ad78bfa011e82133dd5856c9e06a914c0590b0ef21c263

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0036