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Source1

{
  "resourceType": "Composition",
  "id": "568054",
  "meta": {
    "versionId": "4",
    "lastUpdated": "2026-06-07T14:04:07.096Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-12"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-description",
      "valueMarkdown": "Example of M11ReportSection12 Profile"
    },
    {
      "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": "2026-06-07T14:04:07.096Z",
  "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": [
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      "type": {
        "coding": [
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            "system": "http://terminology.hl7.org/CodeSystem/artifact-relationship-type",
            "code": "derived-from",
            "display": "Derived from"
          }
        ]
      },
      "targetReference": {
        "reference": "ResearchStudy/568025",
        "type": "ResearchStudy",
        "display": "M11ResearchStudy Template"
      }
    },
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        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/artifact-relationship-type",
            "code": "cite-as",
            "display": "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 2026-06-07. Available at: https://fevir.net/resources/Composition/568054. Computable resource at: https://fevir.net/resources/Composition/568054#json."
    }
  ],
  "section": [
    {
      "title": "12 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": "12.1 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": "additional",
            "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": "12.2 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": "additional",
            "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": "12.3 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": "additional",
            "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>"
          }
        }
      ]
    }
  ]
}