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SOP-AIDLC-06 — Human-in-the-Loop Review & Sign-off

Defines when and how humans review AI outputs before action, with e-signature.

Owner: Clinical Ops LeadApprover: AI Governance CouncilVersion: 2.0Updated: 12/14/1969

1. Purpose

Ensure Tier 1 and Tier 2 AI outputs affecting patients are reviewed and signed by a qualified human.

2. Scope

All Tier 1 and Tier 2 systems.

3. Definitions

  • HITL — Human-in-the-Loop review of AI output before action.
  • E-signature — Electronic signature that meets 21 CFR Part 11 requirements.

4. Roles & Responsibilities (RACI)

ActivityRACICadence
Configure HITL workflowAI EngineerAI Platform DirectorClinical OpsTeamPer use case
Review outputsReviewer (qualified)Clinical Ops LeadAI EngineerPatientPer case
Sign offReviewer (e-sig)Clinical Ops LeadGRCPatientPer case

5. Procedure

  1. Every Tier 1/2 output must be presented to a qualified reviewer with confidence and citations.
  2. Reviewers can accept, edit, or reject; edits are captured with diff.
  3. Sign-off is captured as an e-signature per 21 CFR Part 11.
  4. Rejected outputs feed back into the evaluation set.

6. Inputs & Outputs

Inputs

  • AI output
  • Reviewer credentials

Outputs

  • Signed decision
  • Reviewer feedback

7. Controls & Metrics

MetricTarget
Tier 1/2 outputs with sign-off before action100%

8. Exceptions & Escalation

  • Time-critical safety escalations (medical emergency) auto-transfer to a live human agent.

9. Records & Retention

RecordRetention
Signed decisions10 years

10. Related Documents

  • SOP-AIDLC-04
  • SOP-AIDLC-08

11. References

  • 21 CFR Part 11
  • NIST AI RMF Manage

12. Revision History

See the Versions tab for the full change history maintained by the Auto-Doc Engine.

Document code: SOP-AIDLC-06 · Aligned to 21 CFR Part 11 / NIST AI RMF Manage. Controlled document — reproduction outside the UBC QMS requires the Quality Manager's approval.

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Frameworks
AI Governance
HIPAA
ISO 9001