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README.md

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1# Clinical Reports References
2
3These references support local, deterministic drafting and review. They are not clinical, legal, regulatory, privacy, publication, or accreditation advice and do not establish compliance.
4

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.

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5## Safety boundary
6
7- Use only synthetic, de-identified, or aggregate data.
8- Populate drafts only from verified authorized source facts.
9- Do not diagnose, treat, dose, triage, interpret raw observations, fabricate results, sign, file, or submit.
10- 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 Public guidance can be reviewed separately without patient or unpublished study details.
11- Keep every output marked as a draft requiring qualified review.

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 Public guidance can be reviewed separately without patient or unpublished study details.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.
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13## File map
15| File | Use |
16|---|---|
17| `report_type_routing.md` | Select the artifact and exact source family before drafting |
18| `case_report_guidelines.md` | CARE case-report structure, consent, and publication safeguards |
19| `diagnostic_reports_standards.md` | Radiology, pathology, and laboratory field boundaries |
20| `clinical_trial_reporting.md` | CONSORT 2025, SPIRIT 2025, ICH E3, and ICH E6(R3) |
21| `safety_reporting.md` | ICH E2 and FDA safety-reporting distinctions |
22| `privacy_and_deidentification.md` | HHS de-identification methods and process limits |
23| `medical_terminology.md` | Versioned terminology and syntax-versus-semantics limits |
24| `data_presentation.md` | Aggregate tables, denominators, units, dates, and missingness |
25| `professional_review.md` | Ethics, accountability, review, and sign-off |
26| `sources.md` | Dated official-source ledger |

File map

FileUse
report_type_routing.mdSelect the artifact and exact source family before drafting
case_report_guidelines.mdCARE case-report structure, consent, and publication safeguards
diagnostic_reports_standards.mdRadiology, pathology, and laboratory field boundaries
clinical_trial_reporting.mdCONSORT 2025, SPIRIT 2025, ICH E3, and ICH E6(R3)
safety_reporting.mdICH E2 and FDA safety-reporting distinctions
privacy_and_deidentification.mdHHS de-identification methods and process limits
medical_terminology.mdVersioned terminology and syntax-versus-semantics limits
data_presentation.mdAggregate tables, denominators, units, dates, and missingness
professional_review.mdEthics, accountability, review, and sign-off
sources.mdDated official-source ledger
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28## Source handling
30`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.

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.

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32## Terminology
34“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.

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.

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