Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

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

Page standards status: Informative

Raw json | Download

{
  "resourceType" : "Composition",
  "id" : "568054",
  "meta" : {
    "versionId" : "1",
    "lastUpdated" : "2026-05-30T15:21:18.907Z",
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-12"
    ]
  },
  "language" : "en",
  "text" : {
    "status" : "extensions",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Composition 568054</b></p><a name=\"568054\"> </a><a name=\"hc568054\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 1; Last updated: 2026-05-30 15:21:18+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-m11-report-section-12.html\">M11ReportSection12</a></p></div><p><b>ArtifactPublicationStatus</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}\">Active</span></p><p><b>url</b>: <a href=\"https://fevir.net/resources/Composition/568054\">https://fevir.net/resources/Composition/568054</a></p><p><b>identifier</b>: FEvIR Object Identifier/568054</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://loinc.org 35528-9}\">CeSHarP Report</span></p><p><b>category</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218666}\">section12-supporting-details</span></p><p><b>date</b>: 2026-05-30 15:21:18+0000</p><p><b>author</b>: Brian S. Alper, MD, MSPH</p><p><b>title</b>: M11 Report Section 12 (Supporting Details) for M11ResearchStudy Template</p><p><b>custodian</b>: <a href=\"Organization-118079.html\">Computable Publishing LLC</a></p><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Derived From</p><p><b>target</b>: <a href=\"ResearchStudy-568025.html\">M11ResearchStudy Template</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Cite As</p><p><b>target</b>: </p><div><p>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.</p>\n</div></blockquote></div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
      "valueCodeableConcept" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
            "code" : "active",
            "display" : "Active"
          }
        ]
      }
    }
  ],
  "url" : "https://fevir.net/resources/Composition/568054",
  "identifier" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code" : "ACSN",
            "display" : "Accession ID"
          }
        ],
        "text" : "FEvIR Object Identifier"
      },
      "system" : "https://fevir.net/FOI",
      "value" : "568054",
      "assigner" : {
        "display" : "Computable Publishing LLC"
      }
    }
  ],
  "status" : "final",
  "type" : {
    "coding" : [
      {
        "system" : "http://loinc.org",
        "code" : "35528-9",
        "display" : "Clinical trial protocol Clinical trial protocol"
      }
    ],
    "text" : "CeSHarP Report"
  },
  "category" : [
    {
      "coding" : [
        {
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C218666",
          "display" : "ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS"
        }
      ],
      "text" : "section12-supporting-details"
    }
  ],
  "subject" : [
    {
      🔗 "reference" : "ResearchStudy/568025",
      "type" : "ResearchStudy",
      "display" : "M11ResearchStudy Template"
    }
  ],
  "date" : "2026-05-30T15:21:18.907Z",
  "author" : [
    {
      "display" : "Brian S. Alper, MD, MSPH"
    }
  ],
  "title" : "M11 Report Section 12 (Supporting Details) for M11ResearchStudy Template",
  "custodian" : {
    🔗 "reference" : "Organization/118079",
    "type" : "Organization",
    "display" : "Computable Publishing LLC"
  },
  "relatesTo" : [
    {
      "type" : "derived-from",
      "targetReference" : {
        🔗 "reference" : "ResearchStudy/568025",
        "type" : "ResearchStudy",
        "display" : "M11ResearchStudy Template"
      }
    },
    {
      "type" : "cite-as",
      "targetMarkdown" : "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."
    }
  ],
  "section" : [
    {
      "title" : "Appendix: Supporting Details",
      "code" : {
        "coding" : [
          {
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C218666",
            "display" : "ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS"
          }
        ],
        "text" : "section12-supporting-details"
      },
      "text" : {
        "status" : "empty",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No text is intended here (heading only).]</div>"
      },
      "section" : [
        {
          "title" : "Clinical Laboratory Tests",
          "code" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C218667",
                "display" : "ICH M11 Protocol Section 12.1 Clinical Laboratory Tests"
              }
            ],
            "text" : "section12.1-clinical-laboratory-tests"
          },
          "text" : {
            "status" : "empty",
            "div" : "<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>"
          }
        },
        {
          "title" : "Country/Region-Specific Differences",
          "code" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C218668",
                "display" : "ICH M11 Protocol Section 12.2 Country/Region-Specific Differences"
              }
            ],
            "text" : "section12.2-country-specific-differences"
          },
          "text" : {
            "status" : "empty",
            "div" : "<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>"
          }
        },
        {
          "title" : "Prior Protocol Amendment(s)",
          "code" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C218669",
                "display" : "ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s)"
              }
            ],
            "text" : "section12.3-prior-protocol-amendments"
          },
          "text" : {
            "status" : "empty",
            "div" : "<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>"
          }
        }
      ]
    }
  ]
}