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Initiation Risk Screen — Completion checklist

Template: TPL-01-04 ../02-Templates/Initiation-Risk-Screen-Template.md | Version: 0.3
How to use: tick an item only after inspecting the completed record and its evidence. Every unticked item needs an OPEN- entry with an owner, or a written, approved disposition.

Content checks

  • [ ] 01. Product intended use and user population — Intended use is one precise statement that a regulatory reviewer can assess.
  • [x] 02. Clinical and patient data boundaries — Each data category is marked processed / not processed with reason.
  • [x] 03. Preliminary foreseeable harm — At least false-negative and false-positive failure modes are considered.
  • [x] 04. Regulated device applicability and jurisdiction — The record states 'decision pending qualified review' or cites the reviewer's written decision — never a self-assessment.
  • [x] 05. Third-party or dataset rights — Each external asset has a rights basis or an open item.
  • [x] 06. Security and privacy escalation triggers — Every triggered condition names the review and its owner.
  • [x] 07. Required expert assessments and hold points — Each hold point names the gate it blocks.

Record control checks

  • [x] Document ID follows KAI-<PRODUCT>-IRS-NNN and is unique in the product.
  • [x] Product, version and commit SHA match the related records.
  • [x] No placeholder rows remain; every gap names an owner and an OPEN- item.
  • [x] Every cited link, file path and ID resolves.
  • [x] Security, privacy, AI/ML and medical-software applicability checked and routed to qualified reviewers where relevant.
  • [x] No patient identifiers, secrets or production data copied into the record.
  • [x] Nothing was taken from the worked examples as if it were evidence.
  • [ ] Named independent reviewer completed review; approval recorded with date.

Reviewer: Technical reviewer (name to be assigned — OPEN-001) | Date: Pending | Outcome: [Complete / Returned with actions]

Self-check by Claude Code, 2026-10-27, at a6b4429. Ticked items were verified in this session (sdlc.py validate --stage 01: 0 errors; sdlc.py trace: no dangling IDs; 78 of 78 code citations resolve at a6b4429). Unticked items stay with the named owners. Reviewer and approval items are for people.

Unticked: 01 → OPEN-004 (intended-use wording is proposed, not confirmed); independent review → OPEN-001.