<custodian> <reference value="Organization/118079"/> <type value="Organization"/> <display value="Computable Publishing LLC"/> </custodian> <relatesTo> <type value="derived-from"/> <targetReference> <reference value="ResearchStudy/568025"/> <type value="ResearchStudy"/> <display value="M11ResearchStudy Template"/> </targetReference> </relatesTo> <relatesTo> <type value="cite-as"/> <targetMarkdown value="M11 Report Section 12 (Supporting Details) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568054. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568054. Computable resource at: https://fevir.net/resources/Composition/568054#json."/> </relatesTo> <section> <title value="Appendix: Supporting Details"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218666"/> <display value="ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS"/> </coding> <text value="section12-supporting-details"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[No text is intended here (heading only).]</div> </text> <section> <title value="Clinical Laboratory Tests"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218667"/> <display value="ICH M11 Protocol Section 12.1 Clinical Laboratory Tests"/> </coding> <text value="section12.1-clinical-laboratory-tests"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Specify which laboratory parameters should be included in each clinical laboratory assessment panel (for example, for haematology, chemistry, urinalysis). A tabular presentation for such information is common. If applicable, include equations and references for locally calculated laboratory results. If not applicable, retain header and enter “Not Applicable.”]</div> </text> </section> <section> <title value="Country/Region-Specific Differences"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218668"/> <display value="ICH M11 Protocol Section 12.2 Country/Region-Specific Differences"/> </coding> <text value="section12.2-country-specific-differences"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Although global clinical trial practices are increasingly harmonised, some country/ region-specific differences in requirements do exist (for example, document retention periods, contraception requirements). Where differences in requirements cannot be reconciled, sponsors should explain how they will document and communicate country/region-specific differences (for example, by country/region-specific amendments or addenda). An alternative to country/region-specific amendments is to list the specific differences by country or countries in this section, including a reference to the relevant section of the protocol where the differing requirement applies. If not applicable, retain header and enter “Not Applicable.”]</div> </text> </section> <section> <title value="Prior Protocol Amendment(s)"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218669"/> <display value="ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s)"/> </coding> <text value="section12.3-prior-protocol-amendments"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[See M11 for specific guidance if not able to simply state {Not applicable. This protocol has not been amended.} or {Not applicable. This is the first protocol amendment.}.]</div> </text> </section> </section> </Composition>

Generated Narrative: Composition 568054

version: 1; Last updated: 2026-05-30 15:21:18+0000

Profile: M11ReportSection12

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/Composition/568054

identifier: FEvIR Object Identifier/568054

status: Final

type: CeSHarP Report

category: section12-supporting-details

date: 2026-05-30 15:21:18+0000

author: Brian S. Alper, MD, MSPH

title: M11 Report Section 12 (Supporting Details) for M11ResearchStudy Template

custodian: Computable Publishing LLC

relatesTo
type: Derived From
target: M11ResearchStudy Template

relatesTo
type: Cite As
target:
M11 Report Section 12 (Supporting Details) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568054. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568054. Computable resource at: https://fevir.net/resources/Composition/568054#json.