Package | hl7.fhir.uv.ebm |
Type | StructureDefinition |
Id | Id |
FHIR Version | R6 |
Source | http://hl7.org/fhir/uv/ebm/https://build.fhir.org/ig/HL7/ebm/StructureDefinition-systematic-review.html |
Url | http://hl7.org/fhir/uv/ebm/StructureDefinition/systematic-review |
Version | 2.0.0-ballot |
Status | draft |
Date | 2024-12-16T14:35:45+00:00 |
Name | SystematicReview |
Experimental | False |
Realm | uv |
Authority | hl7 |
Description | Profile of ResearchStudy for Evidence Based Medicine IG. The SystematicReview Profile is used for a scientific study based on a protocol that includes search and selection of eligible studies, study quality assessment, data extraction, and synthesis. |
Type | ResearchStudy |
Kind | resource |
No resources found
StructureDefinition | |
research-study-excluded-study | ResearchStudyExcludedStudy |
research-study-included-study | ResearchStudyIncludedStudy |
research-study-number-of-studies-identified | ResearchStudyNumberOfStudiesIdentified |
research-study-number-of-studies-included | ResearchStudyNumberOfStudiesIncluded |
research-study-result-as-composition | ResearchStudyResultAsComposition |
research-study-search-strategy | ResearchStudySearchStrategy |
research-study-systematic-review-eligibility-criteria | ResearchStudySystematicReviewEligibilityCriteria |
Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition systematic-review
{
"resourceType" : "StructureDefinition",
"id" : "systematic-review",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: StructureDefinition systematic-review</b></p><a name=\"systematic-review\"> </a><a name=\"hcsystematic-review\"> </a><a name=\"systematic-review-en-US\"> </a><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;\"><tr style=\"border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top\"><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"The logical name of the element\">Name</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Information about the use of the element\">Flags</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Minimum and Maximum # of times the element can appear in the instance\">Card.</a></th><th style=\"width: 100px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Reference to the type of the element\">Type</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Additional information about the element\">Description & Constraints</a><span style=\"float: right\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_resource.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-systematic-review-definitions.html#ResearchStudy\">ResearchStudy</a><a name=\"ResearchStudy\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/researchstudy.html\">ResearchStudy</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Investigation to increase healthcare-related patient-independent knowledge</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_extension_simple.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Simple Extension\" class=\"hierarchy\"/> <a href=\"StructureDefinition-systematic-review-definitions.html#ResearchStudy.extension\">Slices for extension</a><a name=\"ResearchStudy.extension\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/6.0.0-ballot2/extensibility.html#Extension\">Extension</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Extension</span><br/><span style=\"font-weight:bold\">Slice: </span>Unordered, Open by value:url</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-systematic-review-definitions.html#ResearchStudy.extension:author\" title=\"Extension URL = http://hl7.org/fhir/StructureDefinition/artifact-author\">author</a><a name=\"ResearchStudy.extension.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/6.0.0-ballot2/metadatatypes.html#ContactDetail\">ContactDetail</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Who authored the artifact</span><br/><span style=\"font-weight:bold\">URL: </span><a href=\"http://hl7.org/fhir/extensions/5.1.0/StructureDefinition-artifact-author.html\">http://hl7.org/fhir/StructureDefinition/artifact-author</a><br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-systematic-review-definitions.html#ResearchStudy.extension:searchStrategy\" title=\"Extension URL = http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-search-strategy\">searchStrategy</a><a name=\"ResearchStudy.extension.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">Reference</a>(<a href=\"StructureDefinition-search-strategy.html\">SearchStrategy</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Link to search terms and sources.</span><br/><span style=\"font-weight:bold\">URL: </span><a href=\"StructureDefinition-research-study-search-strategy.html\">http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-search-strategy</a><br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-systematic-review-definitions.html#ResearchStudy.extension:systematicReviewEligibilityCriteria\" title=\"Extension URL = http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-systematic-review-eligibility-criteria\">systematicReviewEligibilityCriteria</a><a name=\"ResearchStudy.extension.4\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">Reference</a>(<a href=\"StructureDefinition-systematic-review-eligibility-criteria.html\">SystematicReviewEligibilityCriteria</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Link to inclusion and exclusion criteria for studies.</span><br/><span style=\"font-weight:bold\">URL: </span><a href=\"StructureDefinition-research-study-systematic-review-eligibility-criteria.html\">http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-systematic-review-eligibility-criteria</a></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-systematic-review-definitions.html#ResearchStudy.extension:numberOfStudiesIdentified\" title=\"Extension URL = http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-identified\">numberOfStudiesIdentified</a><a name=\"ResearchStudy.extension.5\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#unsignedInt\">unsignedInt</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Number of studies found on search.</span><br/><span style=\"font-weight:bold\">URL: </span><a href=\"StructureDefinition-research-study-number-of-studies-identified.html\">http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-identified</a></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-systematic-review-definitions.html#ResearchStudy.extension:numberOfStudiesIncluded\" title=\"Extension URL = http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-included\">numberOfStudiesIncluded</a><a name=\"ResearchStudy.extension.6\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#unsignedInt\">unsignedInt</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Number of studies selected for inclusion.</span><br/><span style=\"font-weight:bold\">URL: </span><a href=\"StructureDefinition-research-study-number-of-studies-included.html\">http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-included</a></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-systematic-review-definitions.html#ResearchStudy.extension:includedStudy\" title=\"Extension URL = http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-included-study\">includedStudy</a><a name=\"ResearchStudy.extension.7\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">Reference</a>(<a href=\"http://hl7.org/fhir/R5/citation.html\">Citation</a> | <a href=\"http://hl7.org/fhir/R5/composition.html\">Composition</a> | <a href=\"http://hl7.org/fhir/R5/researchstudy.html\">ResearchStudy</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Link to a research study included in the systematic review.</span><br/><span style=\"font-weight:bold\">URL: </span><a href=\"StructureDefinition-research-study-included-study.html\">http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-included-study</a><br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-systematic-review-definitions.html#ResearchStudy.extension:excludedStudy\" title=\"Extension URL = http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-excluded-study\">excludedStudy</a><a name=\"ResearchStudy.extension.8\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">Reference</a>(<a href=\"http://hl7.org/fhir/R5/citation.html\">Citation</a> | <a href=\"http://hl7.org/fhir/R5/composition.html\">Composition</a> | <a href=\"http://hl7.org/fhir/R5/researchstudy.html\">ResearchStudy</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Link to a research study excluded from the systematic review.</span><br/><span style=\"font-weight:bold\">URL: </span><a href=\"StructureDefinition-research-study-excluded-study.html\">http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-excluded-study</a><br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-systematic-review-definitions.html#ResearchStudy.extension:resultAsComposition\" title=\"Extension URL = http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-result-as-composition\">resultAsComposition</a><a name=\"ResearchStudy.extension.9\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">Reference</a>(<a href=\"http://hl7.org/fhir/R5/composition.html\">Composition</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Link to results generated by the study.</span><br/><span style=\"font-weight:bold\">URL: </span><a href=\"StructureDefinition-research-study-result-as-composition.html\">http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-result-as-composition</a><br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-systematic-review-definitions.html#ResearchStudy.extension:studyRegistration\" title=\"Extension URL = http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration\">studyRegistration</a><a name=\"ResearchStudy.extension.10\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#base64Binary\">base64Binary</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a>, <a href=\"http://hl7.org/fhir/R5/references.html\">canonical</a>(), <a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#date\">date</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#dateTime\">dateTime</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#decimal\">decimal</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#id\">id</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#instant\">instant</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#integer\">integer</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#integer64\">integer64</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#markdown\">markdown</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#oid\">oid</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#positiveInt\">positiveInt</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#time\">time</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#unsignedInt\">unsignedInt</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#url\">url</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#uuid\">uuid</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Address\">Address</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Age\">Age</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Annotation\">Annotation</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Attachment\">Attachment</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a>, <a href=\"http://hl7.org/fhir/R5/references.html\">CodeableReference</a>(), <a href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#ContactPoint\">ContactPoint</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Count\">Count</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Distance\">Distance</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Duration\">Duration</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#HumanName\">HumanName</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Identifier\">Identifier</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Money\">Money</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Period\">Period</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Quantity\">Quantity</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Range\">Range</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Ratio\">Ratio</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#RatioRange\">RatioRange</a>, <a href=\"http://hl7.org/fhir/R5/references.html\">Reference</a>(), <a href=\"http://hl7.org/fhir/R5/datatypes.html#SampledData\">SampledData</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Signature\">Signature</a>, <a href=\"http://hl7.org/fhir/R5/datatypes.html#Timing\">Timing</a>, <a href=\"http://hl7.org/fhir/6.0.0-ballot2/metadatatypes.html#ContactDetail\">ContactDetail</a>, <a href=\"http://hl7.org/fhir/6.0.0-ballot2/metadatatypes.html#DataRequirement\">DataRequirement</a>, <a href=\"http://hl7.org/fhir/R5/metadatatypes.html#Expression\">Expression</a>, <a href=\"http://hl7.org/fhir/6.0.0-ballot2/metadatatypes.html#ParameterDefinition\">ParameterDefinition</a>, <a href=\"http://hl7.org/fhir/6.0.0-ballot2/metadatatypes.html#RelatedArtifact\">RelatedArtifact</a>, <a href=\"http://hl7.org/fhir/6.0.0-ballot2/metadatatypes.html#TriggerDefinition\">TriggerDefinition</a>, <a href=\"http://hl7.org/fhir/6.0.0-ballot2/metadatatypes.html#UsageContext\">UsageContext</a>, <a href=\"http://hl7.org/fhir/R5/metadatatypes.html#Availability\">Availability</a>, <a href=\"http://hl7.org/fhir/R5/metadatatypes.html#ExtendedContactDetail\">ExtendedContactDetail</a>, <a href=\"http://hl7.org/fhir/R5/dosage.html#Dosage\">Dosage</a>, <a href=\"http://hl7.org/fhir/R5/resource.html#Meta\">Meta</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Dates for study registration activities</span><br/><span style=\"font-weight:bold\">URL: </span><a href=\"http://hl7.org/fhir/extensions/5.1.0/StructureDefinition-researchStudy-studyRegistration.html\">http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration</a><br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <span style=\"text-decoration:line-through\">phase</span><a name=\"ResearchStudy.phase\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"text-decoration:line-through\"/><span style=\"text-decoration:line-through\">0</span><span style=\"text-decoration:line-through\">..</span><span style=\"text-decoration:line-through\">0</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <span style=\"text-decoration:line-through\">recruitment</span><a name=\"ResearchStudy.recruitment\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"text-decoration:line-through\"/><span style=\"text-decoration:line-through\">0</span><span style=\"text-decoration:line-through\">..</span><span style=\"text-decoration:line-through\">0</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr><td colspan=\"5\" class=\"hierarchy\"><br/><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 1
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "cds"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "draft"
}
],
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/systematic-review",
"identifier" : [
{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.40.44.42.106"
}
],
"version" : "2.0.0-ballot",
"name" : "SystematicReview",
"status" : "draft",
"date" : "2024-12-16T14:35:45+00:00",
"publisher" : "HL7 International / Clinical Decision Support",
"contact" : [
{
"name" : "HL7 International / Clinical Decision Support",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/dss"
}
]
}
],
"description" : "Profile of ResearchStudy for Evidence Based Medicine IG. The SystematicReview Profile is used for a scientific study based on a protocol that includes search and selection of eligible studies, study quality assessment, data extraction, and synthesis.",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
]
}
],
"fhirVersion" : "6.0.0-ballot2",
"mapping" : [
{
"identity" : "w5",
"uri" : "http://hl7.org/fhir/fivews",
"name" : "FiveWs Pattern Mapping"
},
{
"identity" : "BRIDG5.1",
"uri" : "https://bridgmodel.nci.nih.gov",
"name" : "BRIDG 5.1 Mapping"
},
{
"identity" : "v2",
"uri" : "http://hl7.org/v2",
"name" : "HL7 V2 Mapping"
},
{
"identity" : "rim",
"uri" : "http://hl7.org/v3",
"name" : "RIM Mapping"
},
{
"identity" : "clinicaltrials-gov",
"uri" : "http://clinicaltrials.gov",
"name" : "ClinicalTrials.gov Mapping"
}
],
"kind" : "resource",
"abstract" : false,
"type" : "ResearchStudy",
"baseDefinition" : "http://hl7.org/fhir/StructureDefinition/ResearchStudy",
"derivation" : "constraint",
"snapshot" : {
"element" : [
{
"id" : "ResearchStudy",
"path" : "ResearchStudy",
"short" : "Investigation to increase healthcare-related patient-independent knowledge",
"definition" : "A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.",
"comment" : "Need to make sure we encompass public health studies.",
"alias" : [
"Clinical Trial",
"Study"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy",
"min" : 0,
"max" : "*"
},
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{
"key" : "dom-2",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression" : "contained.contained.empty()",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-3",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
"expression" : "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-4",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-5",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a security label",
"expression" : "contained.meta.security.empty()",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown" : "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
}
],
"key" : "dom-6",
"severity" : "warning",
"human" : "A resource should have narrative for robust management",
"expression" : "text.`div`.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "Entity, Role, or Act,Observation[classCode=CLNTRL, moodCode=EVN]"
},
{
"identity" : "w5",
"map" : "clinical.diagnostics"
},
{
"identity" : "BRIDG5.1",
"map" : "ObservationalStudyProtocolVersion; Study;\nStudyProtocolVersion"
},
{
"identity" : "v2",
"map" : "OBX"
}
]
},
{
"id" : "ResearchStudy.id",
"path" : "ResearchStudy.id",
"short" : "Logical id of this artifact",
"definition" : "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment" : "Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "id"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchStudy.meta",
"path" : "ResearchStudy.meta",
"short" : "Metadata about the resource",
"definition" : "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.meta",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Meta"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchStudy.implicitRules",
"path" : "ResearchStudy.implicitRules",
"short" : "A set of rules under which this content was created",
"definition" : "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
"comment" : "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.implicitRules",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation",
"isSummary" : true
},
{
"id" : "ResearchStudy.language",
"path" : "ResearchStudy.language",
"short" : "Language of the resource content",
"definition" : "The base language in which the resource is written.",
"comment" : "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.language",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Language"
}
],
"strength" : "required",
"description" : "IETF language tag for a human language",
"valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2",
"additional" : [
{
"purpose" : "starter",
"valueSet" : "http://hl7.org/fhir/ValueSet/languages"
}
]
}
},
{
"id" : "ResearchStudy.text",
"path" : "ResearchStudy.text",
"short" : "Text summary of the resource, for human interpretation",
"definition" : "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
"comment" : "Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.",
"alias" : [
"narrative",
"html",
"xhtml",
"display"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.text",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Narrative"
}
],
"condition" : [
"dom-6"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "Act.text?"
}
]
},
{
"id" : "ResearchStudy.contained",
"path" : "ResearchStudy.contained",
"short" : "Contained, inline Resources",
"definition" : "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.",
"comment" : "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.",
"alias" : [
"inline resources",
"anonymous resources",
"contained resources"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.contained",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Resource"
}
],
"condition" : [
"dom-2",
"dom-4",
"dom-3",
"dom-5"
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "ResearchStudy.extension",
"path" : "ResearchStudy.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"ordered" : false,
"rules" : "open"
},
"short" : "Extension",
"definition" : "An Extension",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.extension:author",
"path" : "ResearchStudy.extension",
"sliceName" : "author",
"short" : "Who authored the artifact",
"definition" : "An individual or organization primarily involved in the creation and maintenance of the artifact.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/StructureDefinition/artifact-author"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"mustSupport" : false,
"isModifier" : false
},
{
"id" : "ResearchStudy.extension:searchStrategy",
"path" : "ResearchStudy.extension",
"sliceName" : "searchStrategy",
"short" : "Link to search terms and sources.",
"definition" : "Link to search terms and sources, using a Group Resource (SearchStrategy Profile).",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-search-strategy"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"mustSupport" : false,
"isModifier" : false
},
{
"id" : "ResearchStudy.extension:systematicReviewEligibilityCriteria",
"path" : "ResearchStudy.extension",
"sliceName" : "systematicReviewEligibilityCriteria",
"short" : "Link to inclusion and exclusion criteria for studies.",
"definition" : "Link to criteria for inclusion of studies in the systematic review, using a Group Resource (StudyEligibilityCriteria Profile).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-systematic-review-eligibility-criteria"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"mustSupport" : false,
"isModifier" : false
},
{
"id" : "ResearchStudy.extension:numberOfStudiesIdentified",
"path" : "ResearchStudy.extension",
"sliceName" : "numberOfStudiesIdentified",
"short" : "Number of studies found on search.",
"definition" : "Number of studies found on search to be evaluated for inclusion.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-identified"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"mustSupport" : false,
"isModifier" : false
},
{
"id" : "ResearchStudy.extension:numberOfStudiesIncluded",
"path" : "ResearchStudy.extension",
"sliceName" : "numberOfStudiesIncluded",
"short" : "Number of studies selected for inclusion.",
"definition" : "Number of studies selected for inclusion.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-included"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"mustSupport" : false,
"isModifier" : false
},
{
"id" : "ResearchStudy.extension:includedStudy",
"path" : "ResearchStudy.extension",
"sliceName" : "includedStudy",
"short" : "Link to a research study included in the systematic review.",
"definition" : "Link to a research study included in the systematic review.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-included-study"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"mustSupport" : false,
"isModifier" : false
},
{
"id" : "ResearchStudy.extension:excludedStudy",
"path" : "ResearchStudy.extension",
"sliceName" : "excludedStudy",
"short" : "Link to a research study excluded from the systematic review.",
"definition" : "Link to a research study excluded from the systematic review.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-excluded-study"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"mustSupport" : false,
"isModifier" : false
},
{
"id" : "ResearchStudy.extension:resultAsComposition",
"path" : "ResearchStudy.extension",
"sliceName" : "resultAsComposition",
"short" : "Link to results generated by the study.",
"definition" : "Link to results generated by the study, using a Composition Resource.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-result-as-composition"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"mustSupport" : false,
"isModifier" : false
},
{
"id" : "ResearchStudy.extension:studyRegistration",
"path" : "ResearchStudy.extension",
"sliceName" : "studyRegistration",
"short" : "Dates for study registration activities",
"definition" : "Dates for study registration activities.",
"comment" : "Used to separate study registration activities from study progress status.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"mustSupport" : false,
"isModifier" : false
},
{
"id" : "ResearchStudy.modifierExtension",
"path" : "ResearchStudy.modifierExtension",
"short" : "Extensions that cannot be ignored",
"definition" : "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/6.0.0-ballot2/extensibility.html#modifierExtension).",
"alias" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "ResearchStudy.url",
"path" : "ResearchStudy.url",
"short" : "Canonical identifier for this study resource",
"definition" : "Canonical identifier for this study resource, represented as a globally unique URI.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.url",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.identifier",
"path" : "ResearchStudy.identifier",
"short" : "Business Identifier for study",
"definition" : "Identifiers assigned to this research study by the sponsor or other systems.",
"requirements" : "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.identifier",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Identifier"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Organization's Unique Protocol ID; Secondary IDs"
},
{
"identity" : "w5",
"map" : "FiveWs.identifier"
},
{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)"
},
{
"identity" : "rim",
"map" : ".identifier"
}
]
},
{
"id" : "ResearchStudy.version",
"path" : "ResearchStudy.version",
"short" : "The business version for the study record",
"definition" : "The business version for the study record.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.version",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.name",
"path" : "ResearchStudy.name",
"short" : "Name for this study (computer friendly)",
"definition" : "Name for this study (computer friendly).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.name",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.title",
"path" : "ResearchStudy.title",
"short" : "Human readable name of the study",
"definition" : "The human readable name of the research study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.title",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Brief Title"
},
{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)"
}
]
},
{
"id" : "ResearchStudy.label",
"path" : "ResearchStudy.label",
"short" : "Additional names for the study",
"definition" : "Additional names for the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.label",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.label.id",
"path" : "ResearchStudy.label.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "ResearchStudy.label.extension",
"path" : "ResearchStudy.label.extension",
"short" : "Additional content defined by implementations",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "ResearchStudy.label.modifierExtension",
"path" : "ResearchStudy.label.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/6.0.0-ballot2/extensibility.html#modifierExtension).",
"alias" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "ResearchStudy.label.type",
"path" : "ResearchStudy.label.type",
"short" : "primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid",
"definition" : "Kind of name.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.label.type",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "TitleType"
}
],
"strength" : "extensible",
"description" : "desc.",
"valueSet" : "http://hl7.org/fhir/ValueSet/title-type"
}
},
{
"id" : "ResearchStudy.label.value",
"path" : "ResearchStudy.label.value",
"short" : "The name",
"definition" : "The name.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.label.value",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.protocol",
"path" : "ResearchStudy.protocol",
"short" : "Steps followed in executing study",
"definition" : "The set of steps expected to be performed as part of the execution of the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.protocol",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/PlanDefinition"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Interventions; Arm/Intervention Cross-Reference"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolDocumentVersionPublicTitle.name"
},
{
"identity" : "rim",
"map" : ".outboundRelationship[typeCode=DEFN].target"
}
]
},
{
"id" : "ResearchStudy.partOf",
"path" : "ResearchStudy.partOf",
"short" : "Part of larger study",
"definition" : "A larger research study of which this particular study is a component or step.",
"requirements" : "Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.",
"alias" : [
"container"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.partOf",
"min" : 0,
"max" : "*"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-hierarchy",
"valueBoolean" : true
}
],
"code" : "Reference",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/ResearchStudy"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "BRIDG5.1",
"map" : "CompanionStudyRelationship"
},
{
"identity" : "rim",
"map" : ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"
}
]
},
{
"id" : "ResearchStudy.relatedArtifact",
"path" : "ResearchStudy.relatedArtifact",
"short" : "References, URLs, and attachments",
"definition" : "Citations, references, URLs and other related documents. When using relatedArtifact to share URLs, the relatedArtifact.type will often be set to one of \"documentation\" or \"supported-with\" and the URL value will often be in relatedArtifact.document.url but another possible location is relatedArtifact.resource when it is a canonical URL.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.relatedArtifact",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "RelatedArtifact"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Citations, Links, Available Study Data/Documents"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolDocument, StudyProtocolDocumentVersion"
}
]
},
{
"id" : "ResearchStudy.date",
"path" : "ResearchStudy.date",
"short" : "Date the resource last changed",
"definition" : "The date (and optionally time) when the ResearchStudy Resource was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changes.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.date",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "dateTime"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.status",
"path" : "ResearchStudy.status",
"short" : "draft | active | retired | unknown",
"definition" : "The publication state of the resource (not of the study).",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchStudy.status",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid",
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PublicationStatus"
}
],
"strength" : "required",
"description" : "Codes that convey the current publication status of the research study resource.",
"valueSet" : "http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2"
},
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyOverallStatus.code"
},
{
"identity" : "rim",
"map" : ".status"
}
]
},
{
"id" : "ResearchStudy.primaryPurposeType",
"path" : "ResearchStudy.primaryPurposeType",
"short" : "treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility",
"definition" : "The type of study based upon the intent of the study activities. A classification of the intent of the study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.primaryPurposeType",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyPrimaryPurposeType"
}
],
"strength" : "preferred",
"description" : "Codes for the main intent of the study.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-prim-purp-type"
},
"mapping" : [
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolVersion.primaryPurposeTypeCode"
}
]
},
{
"id" : "ResearchStudy.phase",
"path" : "ResearchStudy.phase",
"short" : "n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4",
"definition" : "The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"min" : 0,
"max" : "0",
"base" : {
"path" : "ResearchStudy.phase",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyPhase"
}
],
"strength" : "example",
"description" : "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-phase"
},
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Study Phase"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolVersion.phaseCode"
}
]
},
{
"id" : "ResearchStudy.studyDesign",
"path" : "ResearchStudy.studyDesign",
"short" : "Classifications of the study design characteristics",
"definition" : "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.studyDesign",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "StudyDesign"
}
],
"strength" : "preferred",
"description" : "This is a set of terms for study design characteristics.",
"valueSet" : "http://hl7.org/fhir/ValueSet/study-design"
},
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"
},
{
"identity" : "BRIDG5.1",
"map" : "InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"
}
]
},
{
"id" : "ResearchStudy.focus",
"path" : "ResearchStudy.focus",
"short" : "Drugs, devices, etc. under study",
"definition" : "The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.focus",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableReference",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/Medication",
"http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition",
"http://hl7.org/fhir/StructureDefinition/SubstanceDefinition",
"http://hl7.org/fhir/StructureDefinition/EvidenceVariable"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyFocusType"
}
],
"strength" : "example",
"description" : "Common codes of research study focus",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-focus-type"
}
},
{
"id" : "ResearchStudy.condition",
"path" : "ResearchStudy.condition",
"short" : "Condition being studied",
"definition" : "The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion \"healthy volunteer\", but the target condition code would be a Lupus SNOMED code.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.condition",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ConditionCode"
}
],
"strength" : "example",
"description" : "Identification of the condition or diagnosis.",
"valueSet" : "http://hl7.org/fhir/ValueSet/condition-code"
},
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Conditions"
},
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyCondition.code"
}
]
},
{
"id" : "ResearchStudy.keyword",
"path" : "ResearchStudy.keyword",
"short" : "Used to search for the study",
"definition" : "Key terms to aid in searching for or filtering the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.keyword",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyKeyword"
}
],
"strength" : "example",
"description" : "Words associated with the study that may be useful in discovery."
},
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Keywords"
},
{
"identity" : "BRIDG5.1",
"map" : "DocumentVersion.keywordCode; DocumentVersion.keywordText"
}
]
},
{
"id" : "ResearchStudy.region",
"path" : "ResearchStudy.region",
"short" : "Geographic area for the study",
"definition" : "A country, state or other area where the study is taking place rather than its precise geographic location or address.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.region",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Jurisdiction"
}
],
"strength" : "extensible",
"description" : "Countries and regions within which this artifact is targeted for use.",
"valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
},
"mapping" : [
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolVersion.participatingLocationCode"
}
]
},
{
"id" : "ResearchStudy.descriptionSummary",
"path" : "ResearchStudy.descriptionSummary",
"short" : "Brief text explaining the study",
"definition" : "A brief text for explaining the study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.descriptionSummary",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "markdown"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.description",
"path" : "ResearchStudy.description",
"short" : "Detailed narrative of the study",
"definition" : "A detailed and human-readable narrative of the study. E.g., study abstract.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.description",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "markdown"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Detailed Description"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolDocumentVersion.publicDescription"
}
]
},
{
"id" : "ResearchStudy.period",
"path" : "ResearchStudy.period",
"short" : "When the study began and ended",
"definition" : "Identifies the start date and the expected (or actual, depending on status) end date for the study.",
"alias" : [
"timing"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.period",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Period"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Study Start Date (start); Study Completion Date (end)"
},
{
"identity" : "w5",
"map" : "FiveWs.done[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration"
},
{
"identity" : "rim",
"map" : ".effectiveTime"
}
]
},
{
"id" : "ResearchStudy.site",
"path" : "ResearchStudy.site",
"short" : "Facility where study activities are conducted",
"definition" : "A facility in which study activities are conducted.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.site",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/Location",
"http://hl7.org/fhir/StructureDefinition/ResearchStudy",
"http://hl7.org/fhir/StructureDefinition/Organization"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Facility"
},
{
"identity" : "w5",
"map" : "FiveWs.where[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "PlannedStudySite; StudySite"
}
]
},
{
"id" : "ResearchStudy.note",
"path" : "ResearchStudy.note",
"short" : "Comments made about the study",
"definition" : "Comments made about the study by the performer, subject or other participants.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.note",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Annotation"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping"
},
{
"identity" : "rim",
"map" : ".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]"
}
]
},
{
"id" : "ResearchStudy.classifier",
"path" : "ResearchStudy.classifier",
"short" : "Classification for the study",
"definition" : "Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.classifier",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString&q