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-NARROW-SCOPE

enroll_subject

Fictional attempt CT-ATT-0069. Chain position 69. Proof proof-7cb6223c-b001-4752-b12d-801cf7490e1b

  1. Proposed. enroll_subject at S02 A on 2026-03-25T12:00:00.000Z. Recorded at 2026-03-25T12:00:00.000Z. Provenance prov:plt001:BND-CT01-NARROW-SCOPE:CT-ATT-0069.
  2. Evaluated as of 2026-03-25T12:00:00.000Z 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 v2. Credential CT-CRED-NARROW, demo-only.

Present: APR-SP-V2, APR-IRB-V2, APR-SIGN-A, ACT-S02-A, CF-01, CON-S02-0001, APR-IRB-S02, APR-CON-S02, APR-TRN-S02.

Absent: none.

Rules

  • CT-01 · fail · hold

    The site or arm is outside the credential scope.

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

  • CT-02 · pass

    The action names v2, 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 90c7c48aeb413a8511f1cb49b20488f4519fc4604be1766acd8244bddb43cbdd

Proof hash 75b8248799ca4eae391a782caa9f8f739c9d85ca8f9e23e4be6f2891c36b3b15

Input hash 07ac144e23711c6e1810eb0ebc4e9ad1634fcf01962ad7b6f92513c8c607af1e

Signature present

Verify this record

Prior attempt in this ordering: CT-ATT-0068