ICH M11 protocol elements and sections as linked data

https://w3id.org/m11-rdf/

A derived rendering of the ICH M11 Technical Specification (Step 4, 2025-11-19), the ICH M11 code lists and OID Listing, and the ICH M11 Terminology published by NCI EVS (release 2025-12-19): one IRI per protocol element, section and code list; the headings and fields of the ICH M11 Template (Step 4, 2025-11-19), each linked to its section and to the element it realises; and mapping statements from the elements to USDM v4 attributes (usdm-rdf), as stated in the HL7 FHIR Clinical Study Protocol IG ballot mapping (May 2026) and the CDISC DDF-RA v4.0.0 M11 mapping. Draft, not normative. Not an ICH, CDISC or HL7 artifact, and not endorsed or sponsored by ICH.

Release: v0.3.0 · version IRI https://w3id.org/m11-rdf/0.3.0
Elements: 270 · one IRI each, <namespace code list>.<concept code>, e.g. Approval Date C217356.C132352
Sections: 160 · identified by their C217272 term
Code lists: 39 · 16 namespaces, 23 value code lists, with ICH OIDs
Mapping statements: 496 SSSOM records (252 HL7 CSP IG ballot, 244 CDISC DDF-RA v4.0.0) to 43 USDM attributes, on 215 elements · SSSOM/TSV · SSSOM/RDF · identification report
ICH M11 Template: 159 headings and 281 fields on their sections, 271 fields linked to the element they realise · D5 report
Whole graph: Turtle · N-Triples · RDF/XML · JSON-LD
Reports: reconciliation of the sources · tests · D2 identification · D2 tests · D5 Template · D5 tests
Slides: ICH M11 elements: a target to map to · what m11-rdf gives when mapping protocol content to ICH M11 and USDM v4, what is left, and questions for USDM 4.1 (PDF, eight slides)
Design note: D4 skeleton: how a study, a document section or a template field points at the element it realises

Namespaces

Namespace	Section	Elements
ICH M11 Section 1 Terminology	1 PROTOCOL SUMMARY	38
ICH M11 Section 2 Terminology	2 INTRODUCTION	6
ICH M11 Section 3 Terminology	3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS	9
ICH M11 Section 4 Terminology	4 TRIAL DESIGN	18
ICH M11 Section 5 Terminology	5 TRIAL POPULATION	12
ICH M11 Section 6 Terminology	6 TRIAL INTERVENTION AND CONCOMITANT THERAPY	33
ICH M11 Section 7 Terminology	7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL	5
ICH M11 Section 8 Terminology	8 TRIAL ASSESSMENTS AND PROCEDURES	17
ICH M11 Section 9 Terminology	9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS	25
ICH M11 Section 10 Terminology	10 STATISTICAL CONSIDERATIONS	16
ICH M11 Section 11 Terminology	11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS	23
ICH M11 Section 12 Terminology	12 APPENDIX: SUPPORTING DETAILS	14
ICH M11 Section 13 Terminology	13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS	1
ICH M11 Section 14 Terminology	14 APPENDIX: REFERENCES	1
ICH M11 Section Amendment Details Terminology	Amendment Details	14
ICH M11 Section Title Page Terminology	Title Page	38

Draft, not normative. A derived rendering of the ICH M11 Technical Specification, Template, code lists and OID Listing (© ICH, used under the ICH Legal Mentions) and of the ICH M11 Terminology published by NCI EVS (CC BY 4.0). Not an ICH, CDISC or HL7 artifact, and not endorsed or sponsored by ICH.