Generated Narrative: ValueSet limited-m11-section-codes

This value set expansion contains 16 concepts.

SystemCodeDisplay
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217342ICH M11 Protocol Section 1 PROTOCOL SUMMARY
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217343ICH M11 Protocol Section 2 INTRODUCTION
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217344ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217345ICH M11 Protocol Section 4 TRIAL DESIGN
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217346ICH M11 Protocol Section 5 TRIAL POPULATION
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217347ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217348ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217349ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217350ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217351ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217352ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217353ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217354ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217355ICH M11 Protocol Section 14 APPENDIX: REFERENCES
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217356ICH M11 Protocol Section Title Page
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217357ICH M11 Protocol Section Amendment Details
 <status value="active"/> <experimental value="false"/> <date value="2026-10-02T12:47:35+00:00"/> <publisher value="HL7 International / Clinical Decision Support"/> <contact> <name value="HL7 International / Clinical Decision Support"/> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/dss"/> </telecom> </contact> <description value="These codes are specified in the M11 technical specification."/> <jurisdiction> <coding> <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/> <code value="001"/> <display value="World"/> </coding> </jurisdiction> <copyright value="Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license."/> <compose> <include> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <concept> <code value="C217342"/> <display value="ICH M11 Protocol Section 1 PROTOCOL SUMMARY"/> </concept> <concept> <code value="C217343"/> <display value="ICH M11 Protocol Section 2 INTRODUCTION"/> </concept> <concept> <code value="C217344"/> <display value="ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS"/> </concept> <concept> <code value="C217345"/> <display value="ICH M11 Protocol Section 4 TRIAL DESIGN"/> </concept> <concept> <code value="C217346"/> <display value="ICH M11 Protocol Section 5 TRIAL POPULATION"/> </concept> <concept> <code value="C217347"/> <display value="ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY"/> </concept> <concept> <code value="C217348"/> <display value="ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL"/> </concept> <concept> <code value="C217349"/> <display value="ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES"/> </concept> <concept> <code value="C217350"/> <display value="ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS"/> </concept> <concept> <code value="C217351"/> <display value="ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS"/> </concept> <concept> <code value="C217352"/> <display value="ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS"/> </concept> <concept> <code value="C217353"/> <display value="ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS"/> </concept> <concept> <code value="C217354"/> <display value="ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS"/> </concept> <concept> <code value="C217355"/> <display value="ICH M11 Protocol Section 14 APPENDIX: REFERENCES"/> </concept> <concept> <code value="C217356"/> <display value="ICH M11 Protocol Section Title Page"/> </concept> <concept> <code value="C217357"/> <display value="ICH M11 Protocol Section Amendment Details"/> </concept> </include> </compose> <expansion> <identifier value="urn:uuid:example-expansion-id"/> <timestamp value="2026-10-02T00:00:00Z"/> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217342"/> <display value="ICH M11 Protocol Section 1 PROTOCOL SUMMARY"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217343"/> <display value="ICH M11 Protocol Section 2 INTRODUCTION"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217344"/> <display value="ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217345"/> <display value="ICH M11 Protocol Section 4 TRIAL DESIGN"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217346"/> <display value="ICH M11 Protocol Section 5 TRIAL POPULATION"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217347"/> <display value="ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217348"/> <display value="ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217349"/> <display value="ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217350"/> <display value="ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217351"/> <display value="ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217352"/> <display value="ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217353"/> <display value="ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217354"/> <display value="ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217355"/> <display value="ICH M11 Protocol Section 14 APPENDIX: REFERENCES"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217356"/> <display value="ICH M11 Protocol Section Title Page"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C217357"/> <display value="ICH M11 Protocol Section Amendment Details"/> </contains> </expansion> </ValueSet>