{ "resourceType" : "Requirements", "id" : "DHFPR2-CPS.3.5", "meta" : { "profile" : ["http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/FMFunction"] }, "language" : "en", "text" : { "status" : "extensions", "div" : "
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Description I:

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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Criteria N:
\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n
\n CPS.3.5#01\n \n SHALL\n \n \n \n \n \n \n \n \n

The system SHALL provide the ability to present protocols for patients enrolled in research studies.

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\n CPS.3.5#02\n \n SHALL\n \n \n \n \n \n \n \n \n

The system SHALL provide the ability to capture, maintain and render research study protocols.

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\n CPS.3.5#03\n \n SHOULD\n \n \n \n \n \n \n \n \n

The system SHOULD conform to function AS.9.1 (Support Financial Plan Enrollment), to enable participation in research studies.

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\n \n
\n CPS.3.5#04\n \n SHOULD\n \n \n \n \n \n \n \n \n

The system SHOULD provide the ability to analyze and maintain patients participating in research studies.

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\n CPS.3.5#05\n \n MAY\n \n \n \n \n \n \n \n \n

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.

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\n CPS.3.5#06\n \n SHALL\n \n \n \n \n \n \n \n \n

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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\n CPS.3.5#07\n \n SHOULD\n \n \n \n \n \n \n \n \n

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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\n CPS.3.5#08\n \n SHOULD\n \n \n \n \n \n \n \n \n

The system SHOULD determine patients eligible for known active clinical research protocols as defined by inclusion and exclusion criteria.

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\n CPS.3.5#09\n \n SHOULD\n \n \n \n \n \n \n \n \n

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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\n CPS.3.5#10\n \n SHOULD\n \n \n \n \n \n \n \n \n

The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation.

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" }, "extension" : [{ "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode" : "informative" }, { "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-change-info", "valueCode" : "NC" }, { "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode" : "ehr" }, { "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger" : 1, "_valueInteger" : { "extension" : [{ "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom", "valueCanonical" : "http://hl7.org/ehrs/us/dhfpr2/ImplementationGuide/hl7.ehrs.us.dhfpr2" }] } }], "url" : "http://hl7.org/ehrs/us/dhfpr2/Requirements/DHFPR2-CPS.3.5", "version" : "2.0.0-ballot", "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" : "2025-12-19T08:44:27+00:00", "publisher" : "HL7 International / Electronic Health Records", "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" : "urn:iso:std:iso:3166", "code" : "US" }] }], "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.", "derivedFrom" : ["http://hl7.org/ehrs/uv/ehrsfmr2/Requirements/EHRSFMR2-CPS.3.5"], "statement" : [{ "extension" : [{ "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent", "valueBoolean" : false }, { "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-change-info", "valueCode" : "NC" }], "key" : "DHFPR2-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" : "CPS.3.5#1" }, { "extension" : [{ "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent", "valueBoolean" : false }, { "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-change-info", "valueCode" : "NC" }], "key" : "DHFPR2-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" : "CPS.3.5#2" }, { "extension" : [{ "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent", "valueBoolean" : false }, { "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-change-info", "valueCode" : "NC" }], "key" : "DHFPR2-CPS.3.5-03", "label" : "CPS.3.5#03", "conformance" : ["SHOULD"], "conditionality" : false, "requirement" : "The system SHOULD conform to function [AS.9.1](Requirements-DHFPR2-AS.9.1.html) (Support Financial Plan Enrollment), to enable participation in research studies.", "derivedFrom" : "CPS.3.5#3" }, { "extension" : [{ "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent", "valueBoolean" : false }, { "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-change-info", "valueCode" : "NC" }], "key" : "DHFPR2-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" : "CPS.3.5#4" }, { "extension" : [{ "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent", "valueBoolean" : false }, { "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-change-info", "valueCode" : "NC" }], "key" : "DHFPR2-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" : "CPS.3.5#5" }, { "extension" : [{ "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent", "valueBoolean" : false }, { "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-change-info", "valueCode" : "NC" }], "key" : "DHFPR2-CPS.3.5-06", "label" : "CPS.3.5#06", "conformance" : ["SHALL"], "conditionality" : false, "requirement" : "The system SHALL conform to function [CP.3.3](Requirements-DHFPR2-CP.3.3.html) (Manage Clinical Documents and Notes) to capture patient condition and response to treatment.", "derivedFrom" : "CPS.3.5#6" }, { "extension" : [{ "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent", "valueBoolean" : false }, { "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-change-info", "valueCode" : "NC" }], "key" : "DHFPR2-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.", "derivedFrom" : "CPS.3.5#7" }, { "extension" : [{ "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent", "valueBoolean" : false }, { "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-change-info", "valueCode" : "NC" }], "key" : "DHFPR2-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.", "derivedFrom" : "CPS.3.5#8" }, { "extension" : [{ "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent", "valueBoolean" : false }, { "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-change-info", "valueCode" : "NC" }], "key" : "DHFPR2-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.", "derivedFrom" : "CPS.3.5#9" }, { "extension" : [{ "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent", "valueBoolean" : false }, { "url" : "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-change-info", "valueCode" : "NC" }], "key" : "DHFPR2-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.", "derivedFrom" : "CPS.3.5#10" }] }