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FHIR IG Statistics: Requirements/EHRSFMR2-CPS.3.5

Packagehl7.ehrs.uv.ehrsfmr2
Resource TypeRequirements
IdEHRSFMR2-CPS.3.5
FHIR VersionR5
Sourcehttp://hl7.org/ehrs/uv/ehrsfmr2/https://build.fhir.org/ig/mvdzel/ehrsfm-fhir-r5/Requirements-EHRSFMR2-CPS.3.5.html
URLhttp://hl7.org/ehrs/uv/ehrsfmr2/Requirements/EHRSFMR2-CPS.3.5
Version2.1.1-ballot
Statusactive
Date2025-05-13T15:11:00+00:00
NameCPS_3_5_Support_for_Research_Protocols_Relative_to_Individual_Patient_Care
TitleCPS.3.5 Support for Research Protocols Relative to Individual Patient Care (Function)
Realmuv
Authorityhl7
DescriptionProvide support for the management of patients enrolled in research protocols.
PurposeThe clinician is presented with appropriate protocols for patients participating in research studies, and is supported in the management and tracking of study participants.

Resources that use this resource

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Resources that this resource uses

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Narrative

Note: links and images are rebased to the (stated) source

Statement N:

Provide support for the management of patients enrolled in research protocols.

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.

Actors:
ehr
Criteria N:
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.


Source

{
  "resourceType": "Requirements",
  "id": "EHRSFMR2-CPS.3.5",
  "meta": {
    "profile": [
      "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/FMFunction"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "ehr"
    }
  ],
  "url": "http://hl7.org/ehrs/uv/ehrsfmr2/Requirements/EHRSFMR2-CPS.3.5",
  "version": "2.1.1-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": "2025-05-13T15:11:00+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": "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/uv/ehrsfmr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "EHRSFMR2-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/uv/ehrsfmr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "EHRSFMR2-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/uv/ehrsfmr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "EHRSFMR2-CPS.3.5-03",
      "label": "CPS.3.5#03",
      "conformance": [
        "SHOULD"
      ],
      "conditionality": false,
      "requirement": "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.",
      "derivedFrom": "EHR-S_FM_R1.1 DC.2.2.3#3"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "EHRSFMR2-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/uv/ehrsfmr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "EHRSFMR2-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/uv/ehrsfmr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "EHRSFMR2-CPS.3.5-06",
      "label": "CPS.3.5#06",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "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."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "EHRSFMR2-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/uv/ehrsfmr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "EHRSFMR2-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/uv/ehrsfmr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "EHRSFMR2-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/uv/ehrsfmr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "EHRSFMR2-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."
    }
  ]
}