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.