clinical-reports

Este extracto es una copia guardada durante la revisión. La fuente externa contiene la versión completa y actual.

---
name: clinical-reports
description: Create safety-bounded draft structures and run local deterministic checks for clinical case, diagnostic, trial, safety, and aggregate research reports. Use only with synthetic, de-identified, or aggregate inputs and verified source-fact manifests; every output requires qualified review.
license: MIT
compatibility: Requires Python 3.11+ only for optional dependency-free local scripts; no network access, credentials, external models, or image services.
metadata:
  version: "2.0"
  skill-author: K-Dense Inc.
---

# Clinical Reports

## Purpose

Prepare **draft reporting structures**, aggregate tables, and review manifests from verified authorized facts. Route each artifact to the correct reporting guidance, preserve provenance, and stop when source support or qualified review is missing.

This skill does not establish legal, regulatory, ethical, journal, accreditation, or institutional compliance. Its scripts check structure and internal consistency only.

## Non-Negotiable Boundary

Never:

- diagnose, recommend treatment, choose or change dosing, triage, or provide return precautions;
- interpret images, specimens, raw laboratory results, symptoms, or other clinical observations;
- invent, infer, normalize, “complete,” or silently reconcile observations, results, dates, units, denominators, causality, expectedness, seriousness, outcomes, or conclusions;
- create an individual case safety report from patient-level narrative or decide reportability;
- sign, attest, approve, file, transmit, submit, amend a source record, or act as a licensed clinician, pathologist, radiologist, laboratorian, safety physician, statistician, privacy officer, attorney, or regulatory professional;
- use real PHI in examples, assets, tests, prompts, logs, or external services;
- call an external LLM, image service, API, or another skill.

All generated artifacts must remain visibly marked:

> DRAFT — NOT FOR CLINICAL USE, SIGNATURE, FILING, OR SUBMISSION. Populate only from verified authorized source records. Qualified review and sign-off are required.

If the request crosses a boundary, stop the unsafe portion. Offer a blank structured template, a source-fact manifest, or a deterministic structural check. Direct clinical or regulatory decisions to the responsible qualified professional.

## Input Gate

Proceed only when all conditions are true:

1. **Purpose is explicit**: publication draft, diagnostic-report scaffold, trial-results manuscript, protocol reporting review, CSR draft, aggregate safety table, or aggregate research summary.
2. **Data class is allowed**: `synthetic`, `deidentified`, or `aggregate`.
3. **Authority is documented**: the requester is authorized to use the records for the stated purpose.
4. **Local-only handling is feasible**: no upload, remote API, telemetry, or credential is needed.
5. **Minimum necessary is defined**: exclude fields not needed for the artifact.
6. **Provenance exists**: every populated field or claim maps to one or more verified source-fact IDs.
7. **Review owner is identified**: qualified clinical, statistical, safety, privacy, legal, journal, and/or regulatory review as applicable.

Do not accept raw free-text patient records when a structured source-fact manifest can be supplied. Do not copy direct identifiers into this skill’s templates or scripts.

## Route Before Drafting

| Artifact | Primary route | Important boundary |
|---|---|---|
| Case report for publication | CARE 2013 checklist and 2017 explanation | Publication consent, privacy, journal policy, and clinical accuracy require human verification |
| Radiology draft scaffold | ACR 2025 communication practice parameter plus modality-specific ACR material | A qualified radiologist authors findings/impression and handles nonroutine communication |
| Pathology draft scaffold | Current specimen-specific CAP Cancer Protocol, if applicable | A qualified pathologist selects the protocol/version and authors diagnosis