tlf-plan-critic

name

tlf-plan-critic

description

Independently audit a TLF plan (produced by the tlf-planner skill) for traceability and completeness before human review. Use this skill after tlf-planner, or whenever the user asks to 'audit/review/QC the TLF plan', 'check TLF coverage', 'verify every endpoint has a table', 'find missing or orphan TLFs', or 'run the coverage/traceability check'. It performs a two-way audit — forward (every objective and every resolved endpoint maps to at least one planned TLF) and backward (every TLF traces to an objective/endpoint or a regulatory rule) — plus conventional-completeness heuristics, then emits a coverage report with a verdict and, on gaps, a bounded re-run plan. It reads only the plan and the study model, never the planner's reasoning, so the check is genuinely independent.

TLF Plan Critic

Purpose

Adversarially verify a TLF plan with fresh eyes. The tlf-planner skill generates the plan; this skill audits it. Keeping generation and criticism in separate skills/contexts is the point — a critic that never saw the generation reasoning catches gaps the generator rationalized away. This runs between tlf-planner and the human review gate:

USDM JSON ──▶ tlf-planner ──▶ [tlf-plan-critic] ──▶ HUMAN REVIEW ──▶ ARD datasets ──▶ {cards}/{cardx} TLFs

When to use

• Immediately after tlf-planner produces tlf-plan.json + tlf-index.md.
• When the user wants to QC, review, or sanity-check a TLF inventory for coverage/completeness.
• To decide whether the plan is ready for human review or needs the planner re-run.

Inputs

Read only these two files (deliberately not the planner's intermediate reasoning):

• outputs/{study-folder}/tlf-plan/tlf-plan.json — the final numbered candidates
• outputs/{study-folder}/tlf-plan/study-model.json — objectives/endpoints to audit against

Output

Write outputs/{study-folder}/tlf-plan/coverage-report.md containing: a coverage matrix (objective → endpoints → TLF ids, each marked covered / gap / clarification), an orphan list, completeness recommendations, clarification action items, counts, a final verdict (clean / clean-with-caveats / gaps-found), and — if gaps — a bounded re-run plan naming what tlf-planner phase should re-run (max ~2 rounds).

Workflow

Read references/audit-checklist.md first, then:

1. Forward coverage — for every objective and every resolved:true endpoint in study-model.json, confirm ≥1 planned TLF in tlf-plan.json traces to it. A resolved endpoint with no TLF is a GAP. An unresolved endpoint (resolved:false, e.g. END9/10/11) is a clarification ACTION ITEM — never a gap, never a silent drop.
2. Backward orphan check — every TLF must trace to an objective/endpoint or a regulatory_rule. Empty objective_ids is valid only when regulatory_rule is set (the scaffolding tables). A candidate with neither is an orphan error. Also flag dangling ids.
3. Completeness heuristics — apply the conventional checks in the checklist (e.g. safety objective present but no deaths table? primary continuous endpoint but no sensitivity/MMRM? multi-site but no by-site table? lab data but no Hy's-Law?). Surface as recommendations.
4. Verdict & routing — summarize counts, choose the verdict, and if gaps exist name the tlf-planner phase(s) to re-run using the checklist's routing table. This skill is read-only: it routes and reports, it never edits the plan.

Expected CDISCPILOT01 result

clean-with-caveats: full forward coverage of END1–END8, zero orphans (the 6 scaffolding tables are valid via regulatory_rule), zero gaps, and 3 open clarification items (END9/END10/END11).

Reference files

• references/audit-checklist.md — the forward/backward/completeness rule lists, unresolved-vs-gap-vs-orphan handling, and the phase-routing table. References the shared schemas at ../../tlf-planner/references/.