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-ARM-B-ACTIVATE

activate_arm

Fictional attempt CT-ATT-0026. Chain position 26. Proof proof-d6f0bd51-7f40-498d-9bfa-c6dd743233f1

  1. Proposed. activate_arm at S04 B on 2026-02-16T15:00:00.000Z. Recorded at 2026-02-16T15:00:00.000Z. Provenance prov:plt001:SCN-ARM-B-ACTIVATE:CT-ATT-0026.
  2. Evaluated as of 2026-02-16T15:00:00.000Z 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-B, APR-IRB-S04, APR-CON-S04, APR-TRN-S04.

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 S04.

    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

    An independent arm sponsor approved the activation.

    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 46cae5c823b82557313a07d64bc7744ced91e545ef07dcfeefbbcc07c2e95eb1

Proof hash a81fac6795c89a3fe180eb7e2911a212693c37e0b3c1b704cbdd766f059d6230

Input hash 5de0906f8224ea68f572d41e3e59aa3bfbcf45f983b466ea504b090e1a0d282a

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0025