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-CT04-BEFORE-SIGNOFF

activate_arm

Fictional attempt CT-ATT-0025. Chain position 25. Proof proof-302e8967-6448-4e2f-b694-1395aa108360

  1. Proposed. activate_arm at S05 C on 2026-04-21T15:00:00.000Z. Recorded at 2026-04-21T15:00:00.000Z. Provenance prov:plt001:BND-CT04-BEFORE-SIGNOFF:CT-ATT-0025.
  2. Evaluated as of 2026-04-21T15:00:00.000Z under policy clinical-trial-plt001-v1. Snapshot 8c0075328db2eab4.
  3. HELD. Column mapping condition. Deciding rule CT-02.
  4. Downstream. The simulated downstream action was not executed. Only an AUTHORIZED verdict reaches it.

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 v2. Credential CT-CRED-ARM, demo-only.

Present: APR-SP-V2, APR-IRB-V2, APR-IRB-S05, APR-CON-S05, APR-TRN-S05.

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 · fail · hold

    That arm is not part of the protocol version effective at this site.

    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 · fail · hold

    The protocol version at this site does not include that arm.

    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 fbb9a360245784ebfd6a2ab117e4f818f467794aa53430763de32ee8e314756c

Proof hash 46cae5c823b82557313a07d64bc7744ced91e545ef07dcfeefbbcc07c2e95eb1

Input hash 937d60e6cf8d1a86b985aa72a9a204862c131ba6cc95aa03b17e51af57609001

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0024