正文
获取原文件references/README.md
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.
- Keep data processing local; do not send inputs to external models, APIs, image tools, or other skills. Public guidance can be reviewed separately without patient or unpublished study details.
- 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 2026-09-30. 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.