| Package | hl7.ehrs.ehrsfmr21 |
| Type | Requirements |
| Id | Id |
| FHIR Version | R5 |
| Source | http://hl7.org/ehrs/https://build.fhir.org/ig/mvdzel/ehrsfm-fhir-r5/Requirements-EHRSFMR2.1-CPS.3.5.html |
| Url | http://hl7.org/ehrs/Requirements/EHRSFMR2.1-CPS.3.5 |
| Version | 2.1.0 |
| Status | active |
| Date | 2024-11-26T16:30:50+00:00 |
| 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) |
| Experimental | False |
| Realm | uv |
| Authority | hl7 |
| Description | Provide support for the management of patients enrolled in research protocols. |
| 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. |
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Provide support for the management of patients enrolled in research protocols.
The clinician is presented with appropriate protocols for patients participating in research studies, and is supported in the management and tracking of study participants.
| CPS.3.5#01 | SHALL |
The system SHALL provide the ability to present protocols for patients enrolled in research studies. |
| CPS.3.5#02 | SHALL |
The system SHALL provide the ability to capture, maintain and render research study protocols. |
| CPS.3.5#03 | SHOULD |
The system SHOULD conform to function [[AS.9.1]] (Support Financial Plan Enrollment), to enable participation in research studies. |
| CPS.3.5#04 | SHOULD |
The system SHOULD provide the ability to analyze and maintain patients participating in research studies. |
| CPS.3.5#05 | MAY |
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. |
| CPS.3.5#06 | SHALL |
The system SHALL conform to function [[CP.3.3]] (Manage Clinical Documents and Notes) to capture patient condition and response to treatment. |
| CPS.3.5#07 | SHOULD |
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. |
| CPS.3.5#08 | SHOULD |
The system SHOULD determine patients eligible for known active clinical research protocols as defined by inclusion and exclusion criteria. |
| CPS.3.5#09 | SHOULD |
The system SHOULD present information notifying staff of patient's eligibility for known active clinical research protocols as defined by inclusion and exclusion criteria. |
| CPS.3.5#10 | SHOULD |
The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation. |
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"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",
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"description" : "Provide support for the management of patients enrolled in research protocols.",
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"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" : [
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"key" : "EHRSFMR2.1-CPS.3.5-01",
"label" : "CPS.3.5#01",
"conformance" : [
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"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"
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"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"
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"key" : "EHRSFMR2.1-CPS.3.5-03",
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"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"
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"key" : "EHRSFMR2.1-CPS.3.5-04",
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"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"
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"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"
},
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"extension" : [
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"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
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"key" : "EHRSFMR2.1-CPS.3.5-06",
"label" : "CPS.3.5#06",
"conformance" : [
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"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."
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"extension" : [
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"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
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"key" : "EHRSFMR2.1-CPS.3.5-07",
"label" : "CPS.3.5#07",
"conformance" : [
"SHOULD"
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"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."
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"valueBoolean" : false
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"key" : "EHRSFMR2.1-CPS.3.5-09",
"label" : "CPS.3.5#09",
"conformance" : [
"SHOULD"
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"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."
},
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"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
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"key" : "EHRSFMR2.1-CPS.3.5-10",
"label" : "CPS.3.5#10",
"conformance" : [
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"conditionality" : false,
"requirement" : "The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation."
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]
}
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