HL7 Electronic Health Record System Functional Model, Release 2.1.1
2.1.1 - Normative

HL7 Electronic Health Record System Functional Model, Release 2.1.1, published by HL7 International / Electronic Health Records. This guide is not an authorized publication; it is the continuous build for version 2.1.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ehrsfm-ig/ and changes regularly. See the Directory of published versions

## : CPS.3.5 Support for Research Protocols Relative to Individual Patient Care (Function)

Page standards status: Normative

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    @prefix fhir: <http://hl7.org/fhir/> .
    @prefix owl: <http://www.w3.org/2002/07/owl#> .
    @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
    @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
    @prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

    # - resource -------------------------------------------------------------------

     a fhir:Requirements ;
      fhir:nodeRole fhir:treeRoot ;
      fhir:id [ fhir:v "EHRSFMR2-CPS.3.5"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/FMFunction"^^xsd:anyURI ;
    fhir:l <http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/FMFunction>     ] )
      ] ; #
      fhir:language [ fhir:v "en"] ; #
      fhir:text [
    fhir:status [ fhir:v "extensions" ] ;
    fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\">\n    \n    \n    <div id=\"description\"><b>Description <a href=\"https://hl7.org/fhir/versions.html#std-process\" title=\"Informative Content\" class=\"informative-flag\">I</a>:</b> <div><p>The clinician is presented with appropriate protocols for patients participating in research studies, and is supported in the management and tracking of study participants.</p>\n</div></div>\n    \n    \n    \n    <div id=\"requirements\"><b>Criteria <a href=\"https://hl7.org/fhir/versions.html#std-process\" title=\"Normative Content\" class=\"normative-flag\">N</a>:</b></div>\n    \n    <table id=\"statements\" class=\"grid dict\">\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            CPS.3.5#01\n            </td>\n            <td style=\"padding-left: 4px;\">\n            SHALL\n            \n                \n            \n            \n            \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                <div><p>The system SHALL provide the ability to present protocols for patients enrolled in research studies.</p>\n</div>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            CPS.3.5#02\n            </td>\n            <td style=\"padding-left: 4px;\">\n            SHALL\n            \n                \n            \n            \n            \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                <div><p>The system SHALL provide the ability to capture, maintain and render research study protocols.</p>\n</div>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            CPS.3.5#03\n            </td>\n            <td style=\"padding-left: 4px;\">\n            SHOULD\n            \n                \n            \n            \n            \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                <div><p>The system SHOULD conform to function <a href=\"Requirements-EHRSFMR2-AS.9.1.html\">AS.9.1</a> (Support Financial Plan Enrollment), to enable participation in research studies.</p>\n</div>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            CPS.3.5#04\n            </td>\n            <td style=\"padding-left: 4px;\">\n            SHOULD\n            \n                \n            \n            \n            \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                <div><p>The system SHOULD provide the ability to analyze and maintain patients participating in research studies.</p>\n</div>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            CPS.3.5#05\n            </td>\n            <td style=\"padding-left: 4px;\">\n            MAY\n            \n                \n            \n            \n            \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                <div><p>The system MAY provide the ability to capture and maintain appropriate details of patient condition and response to treatment as required for patients enrolled in research studies.</p>\n</div>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            CPS.3.5#06\n            </td>\n            <td style=\"padding-left: 4px;\">\n            SHALL\n            \n                \n            \n            \n            \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                <div><p>The system SHALL conform to function <a href=\"Requirements-EHRSFMR2-CP.3.3.html\">CP.3.3</a> (Manage Clinical Documents and Notes) to capture patient condition and response to treatment.</p>\n</div>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            CPS.3.5#07\n            </td>\n            <td style=\"padding-left: 4px;\">\n            SHOULD\n            \n                \n            \n            \n            \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                <div><p>The system SHOULD capture, maintain and render research subject disposition information including date/time and trial phase/cycle of study completion/discontinuation as discrete elements.</p>\n</div>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            CPS.3.5#08\n            </td>\n            <td style=\"padding-left: 4px;\">\n            SHOULD\n            \n                \n            \n            \n            \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                <div><p>The system SHOULD determine patients eligible for known active clinical research protocols as defined by inclusion and exclusion criteria.</p>\n</div>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            CPS.3.5#09\n            </td>\n            <td style=\"padding-left: 4px;\">\n            SHOULD\n            \n                \n            \n            \n            \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                <div><p>The system SHOULD present information notifying staff of patient's eligibility for known active clinical research protocols as defined by inclusion and exclusion criteria.</p>\n</div>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            CPS.3.5#10\n            </td>\n            <td style=\"padding-left: 4px;\">\n            SHOULD\n            \n                \n            \n            \n            \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                <div><p>The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation.</p>\n</div>\n                \n            </td>\n        </tr>\n        \n    </table>\n</div>"^^rdf:XMLLiteral ]
      ] ; #
      fhir:extension ( [
    fhir:url [
    fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status>     ] ;
    fhir:value [
    a fhir:Code ;
    fhir:v "normative"     ]
      ] [
    fhir:url [
    fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-wg>     ] ;
    fhir:value [
    a fhir:Code ;
    fhir:v "ehr"     ]
      ] ) ; #
      fhir:url [
    fhir:v "http://hl7.org/ehrs/uv/ehrsfmr2/Requirements/EHRSFMR2-CPS.3.5"^^xsd:anyURI ;
    fhir:l <http://hl7.org/ehrs/uv/ehrsfmr2/Requirements/EHRSFMR2-CPS.3.5>
      ] ; #
      fhir:version [ fhir:v "2.1.1"] ; #
      fhir:name [ fhir:v "CPS_3_5_Support_for_Research_Protocols_Relative_to_Individual_Patient_Care"] ; #
      fhir:title [ fhir:v "CPS.3.5 Support for Research Protocols Relative to Individual Patient Care (Function)"] ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:date [ fhir:v "2025-12-13T09:06:06+00:00"^^xsd:dateTime] ; #
      fhir:publisher [ fhir:v "HL7 International / Electronic Health Records"] ; #
      fhir:contact ( [
        ( fhir:telecom [
    fhir:system [ fhir:v "url" ] ;
    fhir:value [ fhir:v "http://www.hl7.org/Special/committees/ehr" ]     ] )
      ] ) ; #
      fhir:description [ fhir:v "Provide support for the management of patients enrolled in research protocols."] ; #
      fhir:jurisdiction ( [
        ( fhir:coding [
    fhir:system [
    fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ;
    fhir:l <http://unstats.un.org/unsd/methods/m49/m49.htm>       ] ;
    fhir:code [ fhir:v "001" ] ;
    fhir:display [ fhir:v "World" ]     ] )
      ] ) ; #
      fhir:purpose [ fhir:v "The clinician is presented with appropriate protocols for patients participating in research studies, and is supported in the management and tracking of study participants."] ; #
      fhir:statement ( [
        ( fhir:extension [
    fhir:url [
    fhir:v "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
    fhir:l <http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent>       ] ;
    fhir:value [
    a fhir:Boolean ;
    fhir:v false       ]     ] ) ;
    fhir:key [ fhir:v "EHRSFMR2-CPS.3.5-01" ] ;
    fhir:label [ fhir:v "CPS.3.5#01" ] ;
        ( fhir:conformance [ fhir:v "SHALL" ] ) ;
    fhir:conditionality [ fhir:v false ] ;
    fhir:requirement [ fhir:v "The system SHALL provide the ability to present protocols for patients enrolled in research studies." ] ;
    fhir:derivedFrom [ fhir:v "EHR-S_FM_R1.1 DC.2.2.3#1" ]
      ] [
        ( fhir:extension [
    fhir:url [
    fhir:v "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
    fhir:l <http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent>       ] ;
    fhir:value [
    a fhir:Boolean ;
    fhir:v false       ]     ] ) ;
    fhir:key [ fhir:v "EHRSFMR2-CPS.3.5-02" ] ;
    fhir:label [ fhir:v "CPS.3.5#02" ] ;
        ( fhir:conformance [ fhir:v "SHALL" ] ) ;
    fhir:conditionality [ fhir:v false ] ;
    fhir:requirement [ fhir:v "The system SHALL provide the ability to capture, maintain and render research study protocols." ] ;
    fhir:derivedFrom [ fhir:v "EHR-S_FM_R1.1 DC.2.2.3#2" ]
      ] [
        ( fhir:extension [
    fhir:url [
    fhir:v "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
    fhir:l <http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent>       ] ;
    fhir:value [
    a fhir:Boolean ;
    fhir:v false       ]     ] ) ;
    fhir:key [ fhir:v "EHRSFMR2-CPS.3.5-03" ] ;
    fhir:label [ fhir:v "CPS.3.5#03" ] ;
        ( fhir:conformance [ fhir:v "SHOULD" ] ) ;
    fhir:conditionality [ fhir:v false ] ;
    fhir:requirement [ fhir:v "The system SHOULD conform to function [AS.9.1](Requirements-EHRSFMR2-AS.9.1.html) (Support Financial Plan Enrollment), to enable participation in research studies." ] ;
    fhir:derivedFrom [ fhir:v "EHR-S_FM_R1.1 DC.2.2.3#3" ]
      ] [
        ( fhir:extension [
    fhir:url [
    fhir:v "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
    fhir:l <http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent>       ] ;
    fhir:value [
    a fhir:Boolean ;
    fhir:v false       ]     ] ) ;
    fhir:key [ fhir:v "EHRSFMR2-CPS.3.5-04" ] ;
    fhir:label [ fhir:v "CPS.3.5#04" ] ;
        ( fhir:conformance [ fhir:v "SHOULD" ] ) ;
    fhir:conditionality [ fhir:v false ] ;
    fhir:requirement [ fhir:v "The system SHOULD provide the ability to analyze and maintain patients participating in research studies." ] ;
    fhir:derivedFrom [ fhir:v "EHR-S_FM_R1.1 DC.2.2.3#4" ]
      ] [
        ( fhir:extension [
    fhir:url [
    fhir:v "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
    fhir:l <http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent>       ] ;
    fhir:value [
    a fhir:Boolean ;
    fhir:v false       ]     ] ) ;
    fhir:key [ fhir:v "EHRSFMR2-CPS.3.5-05" ] ;
    fhir:label [ fhir:v "CPS.3.5#05" ] ;
        ( fhir:conformance [ fhir:v "MAY" ] ) ;
    fhir:conditionality [ fhir:v false ] ;
    fhir:requirement [ fhir:v "The system MAY provide the ability to capture and maintain appropriate details of patient condition and response to treatment as required for patients enrolled in research studies." ] ;
    fhir:derivedFrom [ fhir:v "EHR-S_FM_R1.1 DC.2.2.3#5" ]
      ] [
        ( fhir:extension [
    fhir:url [
    fhir:v "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
    fhir:l <http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent>       ] ;
    fhir:value [
    a fhir:Boolean ;
    fhir:v false       ]     ] ) ;
    fhir:key [ fhir:v "EHRSFMR2-CPS.3.5-06" ] ;
    fhir:label [ fhir:v "CPS.3.5#06" ] ;
        ( fhir:conformance [ fhir:v "SHALL" ] ) ;
    fhir:conditionality [ fhir:v false ] ;
    fhir:requirement [ fhir:v "The system SHALL conform to function [CP.3.3](Requirements-EHRSFMR2-CP.3.3.html) (Manage Clinical Documents and Notes) to capture patient condition and response to treatment." ]
      ] [
        ( fhir:extension [
    fhir:url [
    fhir:v "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
    fhir:l <http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent>       ] ;
    fhir:value [
    a fhir:Boolean ;
    fhir:v false       ]     ] ) ;
    fhir:key [ fhir:v "EHRSFMR2-CPS.3.5-07" ] ;
    fhir:label [ fhir:v "CPS.3.5#07" ] ;
        ( fhir:conformance [ fhir:v "SHOULD" ] ) ;
    fhir:conditionality [ fhir:v false ] ;
    fhir:requirement [ fhir:v "The system SHOULD capture, maintain and render research subject disposition information including date/time and trial phase/cycle of study completion/discontinuation as discrete elements." ]
      ] [
        ( fhir:extension [
    fhir:url [
    fhir:v "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
    fhir:l <http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent>       ] ;
    fhir:value [
    a fhir:Boolean ;
    fhir:v false       ]     ] ) ;
    fhir:key [ fhir:v "EHRSFMR2-CPS.3.5-08" ] ;
    fhir:label [ fhir:v "CPS.3.5#08" ] ;
        ( fhir:conformance [ fhir:v "SHOULD" ] ) ;
    fhir:conditionality [ fhir:v false ] ;
    fhir:requirement [ fhir:v "The system SHOULD determine patients eligible for known active clinical research protocols as defined by inclusion and exclusion criteria." ]
      ] [
        ( fhir:extension [
    fhir:url [
    fhir:v "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
    fhir:l <http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent>       ] ;
    fhir:value [
    a fhir:Boolean ;
    fhir:v false       ]     ] ) ;
    fhir:key [ fhir:v "EHRSFMR2-CPS.3.5-09" ] ;
    fhir:label [ fhir:v "CPS.3.5#09" ] ;
        ( fhir:conformance [ fhir:v "SHOULD" ] ) ;
    fhir:conditionality [ fhir:v false ] ;
    fhir:requirement [ fhir:v "The system SHOULD present information notifying staff of patient's eligibility for known active clinical research protocols as defined by inclusion and exclusion criteria." ]
      ] [
        ( fhir:extension [
    fhir:url [
    fhir:v "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
    fhir:l <http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent>       ] ;
    fhir:value [
    a fhir:Boolean ;
    fhir:v false       ]     ] ) ;
    fhir:key [ fhir:v "EHRSFMR2-CPS.3.5-10" ] ;
    fhir:label [ fhir:v "CPS.3.5#10" ] ;
        ( fhir:conformance [ fhir:v "SHOULD" ] ) ;
    fhir:conditionality [ fhir:v false ] ;
    fhir:requirement [ fhir:v "The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation." ]
      ] ) . #