医疗报告结构与来源检查

references/sources.md

Research cutoff and access date: 2026-09-30 Method: live official-page/PDF review, with public-page extraction for ACR and BMJ when direct access was blocked. Local scripts, templates, and synthetic tests were audited separately; this skill has no network API client, authentication, pagination, or submission implementation to test. Use: source routing and version awareness only. Always verify the live source, jurisdictional adoption, and local requirements before real-world use.

Case reports

• CARE Case Report Guidelines — home and current toolkit. Identifies the 2013 checklist and 2017 explanation. https://www.care-statement.org/
• 2013 CARE Checklist. Thirteen main reporting items. https://www.care-statement.org/checklist
• CARE publications. Primary 2013 statement and 2017 explanation/elaboration references. https://www.care-statement.org/publications

Randomized-trial protocols and results

• SPIRIT–CONSORT official site. SPIRIT 2025: 34-item protocol checklist and figure. CONSORT 2025: 30-item results checklist and flow diagram. https://www.consort-spirit.org/
• CONSORT/SPIRIT extension catalogue. Current design, data, intervention, and population extensions; catalogue notes which base statement each extension used. https://www.consort-spirit.org/extensions
• CONSORT 2025 primary statement. Published 2025-04-14. https://www.bmj.com/content/389/bmj-2024-081123
• SPIRIT 2025 primary statement. Published 2025-04-28; states that SPIRIT 2025 supersedes SPIRIT 2013. https://www.bmj.com/content/389/bmj-2024-081477
• SPIRIT 2025 explanation and elaboration. Published 2025-04-28. https://www.bmj.com/content/389/bmj-2024-081660

ICH clinical-study and GCP guidance

• ICH E3 — Structure and Content of Clinical Study Reports. Step 4, 1995-11-30. https://database.ich.org/sites/default/files/E3_Guideline.pdf
• ICH E3 Questions & Answers (R1). Current version dated 2012-07-06; clarifies that E3 is adaptable guidance, not a rigid template. https://database.ich.org/sites/default/files/E3_Q%26As_R1_Q%26As.pdf
• ICH E6(R3) consolidated final guideline. Principles, Annex 1, and Annex 2; adopted 2026-06-16. https://database.ich.org/sites/default/files/ICH%20E6%28R3%29_Step4_FinalConsolidatedGuideline_2026_0616_.pdf
• ICH E6(R3) Annex 2 final. Adopted 2026-06-03. https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Annex%202_Guideline_Step%204_2026_0603_0.pdf
• FDA ICH guidance index. General US ICH entry point; its E6 text still describes R2, so it is not sufficient evidence of current regional E6 adoption. https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/ich-guidance-documents
• FDA E6(R3) Good Clinical Practice. Dedicated final-guidance page, September 2025; review the actual regional document and Annex 2 status separately from the ICH consolidated version. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-gcp

Safety reporting

• ICH E2A — Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. Step 4, 1994-10-27. https://database.ich.org/sites/default/files/E2A_Guideline.pdf
• ICH E2B(R3) ICSR specification and related files. Catalogue entry point for implementation guide, Q&As, and code lists; current file list could not be extracted during this review. https://www.ich.org/page/e2br3-individual-case-safety-report-icsr-specification-and-related-files
• FDA E2B(R3) implementation guide. Final April 2022 adoption page with ICH message specification, XML schemas, examples, and FDA regional additions. No message generation or transmission is performed here. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e2br3-electronic-transmission-individual-case-safety-reports-implementation-guide-data-elements-and
• ICH E2C(R2) PBRER. Final Step 4 text corrected 2012-12-17; periodic benefit-risk aggregate reporting, distinct from ICSR message structure. https://database.ich.org/sites/default/files/E2C_R2_Guideline.pdf
• ICH E2D(R1) — Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports. Adopted 2025-09-15. https://database.ich.org/sites/default/files/ICH_E2D%28R1%29_Step4_FinalGuideline_2025_0819.pdf
• 21 CFR 312.32 — IND safety reporting. Current eCFR text; verify current effective text and official annual CFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-B/section-312.32
• FDA IND Application Reporting: IND Safety Reports. Checked 2026-09-30; includes AEMS/E2B(R3) electronic route effective 2026-04-01 within stated scope. https://www.fda.gov/drugs/investigational-new-drug-application-ind/ind-application-reporting-ind-safety-reports
• FDA AEMS Electronic Submissions. Postmarketing E2B(R2) transition ends 2026-09-30; ESG NextGen ICSRs require E2B(R3) from 2026-10-01. SRP users need no action for this transition. https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/fda-adverse-event-monitoring-system-aems-electronic-submissions
• FDA Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies. Final guidance, December 2025. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sponsor-responsibilities-safety-reporting-requirements-and-safety-assessment-ind-and
• FDA Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices. Final guidance, December 2025. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigator-responsibilities-safety-reporting-investigational-drugs-and-devices
• FDA Postmarketing Adverse Event Reporting Compliance Program. Current inspection-program scope, distinct from individual event reportability. https://www.fda.gov/drugs/surveillance-post-drug-approval-activities/postmarketing-adverse-event-reporting-compliance-program

Privacy and de-identification

• HHS Guidance Regarding Methods for De-identification of PHI. Safe Harbor and Expert Determination under 45 CFR 164.514(b); including the limits on identifier-derived codes; public content rechecked. https://www.hhs.gov/hipaa/for-professionals/special-topics/de-identification/index.html
• HHS Minimum Necessary Requirement. 45 CFR 164.502(b) and 164.514(d), scope and exceptions. https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/minimum-necessary-requirement/index.html

Diagnostic reporting

• ACR Practice Parameter for Communication of Diagnostic Imaging Findings. Revised 2025 (Resolution 9). https://gravitas.acr.org/PPTS/GetDocumentView?docId=74
• ACR Practice Parameters & Technical Standards portal. Current modality- and program-specific source. https://gravitas.acr.org/PPTS
• CAP Cancer Protocol Templates. Current protocol downloads and 2026 change notices; updates to 14 protocols on 2026-09-16, including Vaginal Biopsy retirement. Biomarker protocols are guidance and not accreditation requirements. https://www.cap.org/protocols-and-guidelines/cancer-protocols/current-cancer-protocols/
• CAP Cancer Protocols. Current scope and synoptic-reporting entry point. https://www.cap.org/protocols-and-guidelines/cancer-reporting-tools/cancer-protocols
• 42 CFR 493.1291 — Test report. CLIA postanalytic report requirements for applicable testing, including corrected-report handling. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K/subject-group-ECFR9482366886d579f/section-493.1291
• 42 CFR 493.1105 — Retention requirements. Includes original, preliminary, final, and corrected-report retention provisions within scope. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-J/section-493.1105

Terminology

• ICH MedDRA. Governance, purpose, and Points to Consider. https://www.ich.org/page/meddra
• MedDRA English support documentation. Support-document entry point; page extraction did not reliably expose release listings, so version claims use the dated official PDF below. https://www.meddra.org/how-to-use/support-documentation/english/welcome
• MedDRA 29.1 Introductory Guide. September 2026 release, hierarchy and multilingual-code context. https://alt.meddra.org/files_acrobat/intguide_29_1_English.pdf
• LOINC. Version 2.83 released 2026-08-19. https://loinc.org/ and https://loinc.org/kb/loinc-release-notes
• LOINC monthly release plan. Targeted March 2027 launch; a future plan, not the current release cadence. https://loinc.org/monthly
• CDC ICD-10-CM release files. FY26 April update service-date window and future FY27 effective date of 2026-10-01; do not equate downloadable with already applicable. https://www.cdc.gov/nchs/icd/icd-10-cm/files.html
• UCUM specification. Formal grammar and semantics; the bundled regex is only a restricted character screen. https://ucum.org/ucum
• SNOMED International licensing. Member/non-member use and licensing conditions. https://www.snomed.org/licensing
• NLM SNOMED CT licensing. US distribution and licensing entry point. https://www.nlm.nih.gov/healthit/snomedct/snomed_licensing.html

Ethics and professional publication guidance

• WMA Declaration of Helsinki. Current official version adopted October 2024; previous versions superseded for current use. https://www.wma.net/policies-post/wma-declaration-of-helsinki
• ICMJE Recommendations. Updated January 2026; authorship, accountability, participant protection, privacy, and publication practices. https://www.icmje.org/icmje-recommendations.pdf
• AMA Code of Medical Ethics Opinion 3.3.2 — Confidentiality & Electronic Medical Records. Electronic-record confidentiality, access, audit, security, integrity, sharing, and disposition. https://code-medical-ethics.ama-assn.org/ethics-opinions/confidentiality-electronic-medical-records

Known source limitations

• eCFR is continuously updated but identifies itself as an unofficial online edition; use the current official annual CFR and legal review when status matters.
• ICH Step 4 documents require regional adoption/implementation review.
• Controlled terminologies and professional standards can change after this ledger date. No licensed dictionary was downloaded or semantically validated.
• ACR/BMJ direct access returned 403; current official public content was reviewed through extraction. ICH E2B catalogue returned only a page shell, so no claim of a current catalogue/Q&A revision is made.
• The local successful statuses describe structure only; no patient records, production diagnostic reports, safety transmissions, or regulatory compliance were tested.
• Journal instructions, local policies, protocols, SAPs, contracts, and ethics determinations are not captured here.