# CPS.3.5 Support for Research Protocols Relative to Individual Patient Care (Function) - HL7 Electronic Health Record System Functional Model, Release 2.1.1 v2.1.1

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

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



## Resource Content

```json
{
  "resourceType" : "Requirements",
  "id" : "EHRSFMR2-CPS.3.5",
  "meta" : {
    "profile" : [
      "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/FMFunction"
    ]
  },
  "language" : "en",
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode" : "normative"
    },
    {
      "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",
  "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" : "2025-12-13T09:06:06+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."
    }
  ]
}

```
