# Clinical Reports References

These references support local, deterministic drafting and review. They are not clinical, legal, regulatory, privacy, publication, or accreditation advice and do not establish compliance.

## Safety boundary

- Use only synthetic, de-identified, or aggregate data.
- Populate drafts only from verified authorized source facts.
- Do not diagnose, treat, dose, triage, interpret raw observations, fabricate results, sign, file, or submit.
- Do not use external models, APIs, image tools, or cross-skill calls.
- Keep every output marked as a draft requiring qualified review.

## File map

| File | Use |
|---|---|
| `report_type_routing.md` | Select the artifact and exact source family before drafting |
| `case_report_guidelines.md` | CARE case-report structure, consent, and publication safeguards |
| `diagnostic_reports_standards.md` | Radiology, pathology, and laboratory field boundaries |
| `clinical_trial_reporting.md` | CONSORT 2025, SPIRIT 2025, ICH E3, and ICH E6(R3) |
| `safety_reporting.md` | ICH E2 and FDA safety-reporting distinctions |
| `privacy_and_deidentification.md` | HHS de-identification methods and process limits |
| `medical_terminology.md` | Versioned terminology and syntax-versus-semantics limits |
| `data_presentation.md` | Aggregate tables, denominators, units, dates, and missingness |
| `professional_review.md` | Ethics, accountability, review, and sign-off |
| `sources.md` | Dated official-source ledger |

## Source handling

`sources.md` records primary or official sources checked on 2026-07-23. Requirements, regional adoption, controlled terminologies, and professional standards can change. Before real-world use, a qualified reviewer must verify the current official source, applicable jurisdiction, institution, sponsor procedure, protocol, statistical analysis plan, and target-journal instructions.

## Terminology

“Required” in these references means required by the cited source within its stated scope, not universally required. “Complete” means structurally present in a manifest, not clinically correct. Script results never authorize use, release, signature, filing, or submission.