ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
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| Active as of 2024-11-26 |
{
"resourceType" : "Requirements",
"id" : "EHRSFMR2.1-CPS.3.5",
"meta" : {
"profile" : [
🔗 "http://hl7.org/ehrs/StructureDefinition/FMFunction"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <span id=\"description\"><b>Statement <a href=\"https://hl7.org/fhir/versions.html#std-process\" title=\"Normative Content\" class=\"normative-flag\">N</a>:</b> <div><p>Provide support for the management of patients enrolled in research protocols.</p>\n</div></span>\n\n \n <span id=\"purpose\"><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></span>\n \n\n \n\n \n <span id=\"requirements\"><b>Criteria <a href=\"https://hl7.org/fhir/versions.html#std-process\" title=\"Normative Content\" class=\"normative-flag\">N</a>:</b></span>\n \n <table id=\"statements\" class=\"grid dict\">\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#01</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHALL</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHALL provide the ability to present protocols for patients enrolled in research studies.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#02</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHALL</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHALL provide the ability to capture, maintain and render research study protocols.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#03</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD conform to function [[AS.9.1]] (Support Financial Plan Enrollment), to enable participation in research studies.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#04</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD provide the ability to analyze and maintain patients participating in research studies.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#05</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>MAY</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><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></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#06</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHALL</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHALL conform to function [[CP.3.3]] (Manage Clinical Documents and Notes) to capture patient condition and response to treatment.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#07</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><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></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#08</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD determine patients eligible for known active clinical research protocols as defined by inclusion and exclusion criteria.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#09</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><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></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#10</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n </table>\n</div>"
},
"url" : "http://hl7.org/ehrs/Requirements/EHRSFMR2.1-CPS.3.5",
"version" : "2.1.0",
"name" : "CPS_3_5_Support_for_Research_Protocols_Relative_to_Individual_Patient_Care",
"title" : "CPS.3.5 Support for Research Protocols Relative to Individual Patient Care (Function)",
"status" : "active",
"date" : "2024-11-26T16:30:50+00:00",
"publisher" : "EHR WG",
"contact" : [
{
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/ehr"
}
]
}
],
"description" : "Provide support for the management of patients enrolled in research protocols.",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
]
}
],
"purpose" : "The clinician is presented with appropriate protocols for patients participating in research studies, and is supported in the management and tracking of study participants.",
"statement" : [
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.3.5-01",
"label" : "CPS.3.5#01",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL provide the ability to present protocols for patients enrolled in research studies.",
"derivedFrom" : "EHR-S_FM_R1.1 DC.2.2.3#1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.3.5-02",
"label" : "CPS.3.5#02",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL provide the ability to capture, maintain and render research study protocols.",
"derivedFrom" : "EHR-S_FM_R1.1 DC.2.2.3#2"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.3.5-03",
"label" : "CPS.3.5#03",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "The system SHOULD conform to function [[AS.9.1]] (Support Financial Plan Enrollment), to enable participation in research studies.",
"derivedFrom" : "EHR-S_FM_R1.1 DC.2.2.3#3"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.3.5-04",
"label" : "CPS.3.5#04",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "The system SHOULD provide the ability to analyze and maintain patients participating in research studies.",
"derivedFrom" : "EHR-S_FM_R1.1 DC.2.2.3#4"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.3.5-05",
"label" : "CPS.3.5#05",
"conformance" : [
"MAY"
],
"conditionality" : false,
"requirement" : "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.",
"derivedFrom" : "EHR-S_FM_R1.1 DC.2.2.3#5"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.3.5-06",
"label" : "CPS.3.5#06",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL conform to function [[CP.3.3]] (Manage Clinical Documents and Notes) to capture patient condition and response to treatment."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.3.5-07",
"label" : "CPS.3.5#07",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "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."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.3.5-08",
"label" : "CPS.3.5#08",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "The system SHOULD determine patients eligible for known active clinical research protocols as defined by inclusion and exclusion criteria."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.3.5-09",
"label" : "CPS.3.5#09",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "The system SHOULD present information notifying staff of patient's eligibility for known active clinical research protocols as defined by inclusion and exclusion criteria."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.3.5-10",
"label" : "CPS.3.5#10",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation."
}
]
}