# Official Source Ledger

**Research cutoff and access date:** 2026-07-23
**Method:** targeted `parallel-cli search` restricted to official or primary-source domains, followed by review of returned primary-source excerpts.
**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.** FDA’s current US ICH guidance entry point; verify regional adoption here. Content current 2026-04-16 when checked. <https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/ich-guidance-documents>

## 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.** Current implementation-guide, Q&A, code-list, and alignment entry point. <https://www.ich.org/page/e2br3-individual-case-safety-report-icsr-specification-and-related-files>
- **ICH guideline index.** Listed E2B(R3) Q&As at Step 5 dated 2025-07-18 and E2D(R1) at Step 5 dated 2025-09-15 when checked. <https://www.ich.org/page/search-index-ich-guidelines>
- **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.** Content current 2026-06-23; includes AEMS/E2B(R3) electronic route effective 2026-04-01 within stated scope. <https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-reporting-ind-safety-reports>
- **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.** Content current 2025-12-19 when checked. <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); page reviewed 2026-03-20. <https://www.hhs.gov/hipaa/for-professionals/privacy/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; page showed updates through 2026-06-24 when checked. <https://www.cap.org/protocols-and-guidelines/cancer-reporting-tools/cancer-protocol-templates>
- **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.** Lists MedDRA 29.0 (March 2026), transition date 2026-05-04, and versioned support documents. <https://www.meddra.org/how-to-use/support-documentation/english/welcome>
- **MedDRA 29.0 Introductory Guide.** March 2026 hierarchy and version context. <https://alt.meddra.org/files_acrobat/intguide_29_0_English.pdf>
- **LOINC.** Version 2.82 released 2026-02-24; next release listed for August 2026 when checked. <https://loinc.org/>
- **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.
- Journal instructions, local policies, protocols, SAPs, contracts, and ethics determinations are not captured here.