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-CT01-EXPIRED-EXACT

enroll_subject

Fictional attempt CT-ATT-0070. Chain position 70. Proof proof-57a8b436-6792-47aa-ba2f-5d0e444032a6

  1. Proposed. enroll_subject at S01 A on 2026-02-01T00:00:00.000Z. Recorded at 2026-02-01T00:00:00.000Z. Provenance prov:plt001:BND-CT01-EXPIRED-EXACT:CT-ATT-0070.
  2. Evaluated as of 2026-02-01T00:00:00.000Z under policy clinical-trial-plt001-v1. Snapshot 8c0075328db2eab4.
  3. HELD. Column mapping condition. Deciding rule CT-01.
  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 v1. Credential CT-CRED-EXPIRED, demo-only.

Present: APR-SP-V1, APR-IRB-V1, APR-SIGN-A, APR-IRB-S01, APR-CON-S01, APR-TRN-S01.

Absent: arm_activation:S01:A.

Rules

  • CT-01 · fail · hold

    The credential is outside its effective window.

    Illustrative protocol rule: PLT-001 fictional delegation schedule, section 4

  • CT-02 · pass

    The action names v1, which is the version effective at S01.

    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

    No independent activation is effective for this site and 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 · fail · hold

    The documented consent is later than the action.

    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 75b8248799ca4eae391a782caa9f8f739c9d85ca8f9e23e4be6f2891c36b3b15

Proof hash a26fc0184024fd677d5cbab9a4363d5e20b6818bd3f490ae26191cf07f56c365

Input hash 97510d6b53a2fa6fab085794fec3859ad780c90020f0a20ed87de3f21b1554ff

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0069