HL7 Electronic Health Record System Functional Model, Release 2.1.1
2.1.1 - Normative

HL7 Electronic Health Record System Functional Model, Release 2.1.1, published by HL7 International / Electronic Health Records. This guide is not an authorized publication; it is the continuous build for version 2.1.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ehrsfm-ig/ and changes regularly. See the Directory of published versions

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

Page standards status: Normative

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    <Requirements xmlns="http://hl7.org/fhir">
      <id value="EHRSFMR2-CPS.3.5"/>
      <meta>
        <profile
                 value="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/FMFunction"/>
      </meta>
      <language value="en"/>
      <text>
        <status value="extensions"/>
        <div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en">

        <div id="description"><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>
    </div></div>

        <div id="requirements"><b>Criteria <a href="https://hl7.org/fhir/versions.html#std-process" title="Normative Content" class="normative-flag">N</a>:</b></div>

        <table id="statements" class="grid dict">

            <tr>
                <td style="padding-left: 4px;">
                CPS.3.5#01
                </td>
                <td style="padding-left: 4px;">
                SHALL

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL provide the ability to present protocols for patients enrolled in research studies.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CPS.3.5#02
                </td>
                <td style="padding-left: 4px;">
                SHALL

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL provide the ability to capture, maintain and render research study protocols.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CPS.3.5#03
                </td>
                <td style="padding-left: 4px;">
                SHOULD

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHOULD conform to function <a href="Requirements-EHRSFMR2-AS.9.1.html">AS.9.1</a> (Support Financial Plan Enrollment), to enable participation in research studies.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CPS.3.5#04
                </td>
                <td style="padding-left: 4px;">
                SHOULD

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHOULD provide the ability to analyze and maintain patients participating in research studies.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CPS.3.5#05
                </td>
                <td style="padding-left: 4px;">
                MAY

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <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>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CPS.3.5#06
                </td>
                <td style="padding-left: 4px;">
                SHALL

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL conform to function <a href="Requirements-EHRSFMR2-CP.3.3.html">CP.3.3</a> (Manage Clinical Documents and Notes) to capture patient condition and response to treatment.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CPS.3.5#07
                </td>
                <td style="padding-left: 4px;">
                SHOULD

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <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>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CPS.3.5#08
                </td>
                <td style="padding-left: 4px;">
                SHOULD

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHOULD determine patients eligible for known active clinical research protocols as defined by inclusion and exclusion criteria.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CPS.3.5#09
                </td>
                <td style="padding-left: 4px;">
                SHOULD

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <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>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CPS.3.5#10
                </td>
                <td style="padding-left: 4px;">
                SHOULD

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation.</p>
    </div>

                </td>
            </tr>

        </table>
    </div>
      </text>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
        <valueCode value="normative"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
        <valueCode value="ehr"/>
      </extension>
      <url value="http://hl7.org/ehrs/uv/ehrsfmr2/Requirements/EHRSFMR2-CPS.3.5"/>
      <version value="2.1.1"/>
      <name
            value="CPS_3_5_Support_for_Research_Protocols_Relative_to_Individual_Patient_Care"/>
      <title
             value="CPS.3.5 Support for Research Protocols Relative to Individual Patient Care (Function)"/>
      <status value="active"/>
      <date value="2025-12-13T09:06:06+00:00"/>
      <publisher value="HL7 International / Electronic Health Records"/>
      <contact>
        <telecom>
          <system value="url"/>
          <value value="http://www.hl7.org/Special/committees/ehr"/>
        </telecom>
      </contact>
      <description
                   value="Provide support for the management of patients enrolled in research protocols."/>
      <jurisdiction>
        <coding>
          <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
          <code value="001"/>
          <display value="World"/>
        </coding>
      </jurisdiction>
      <purpose
               value="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 value="false"/>
        </extension>
        <key value="EHRSFMR2-CPS.3.5-01"/>
        <label value="CPS.3.5#01"/>
        <conformance value="SHALL"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHALL provide the ability to present protocols for patients enrolled in research studies."/>
        <derivedFrom value="EHR-S_FM_R1.1 DC.2.2.3#1"/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CPS.3.5-02"/>
        <label value="CPS.3.5#02"/>
        <conformance value="SHALL"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHALL provide the ability to capture, maintain and render research study protocols."/>
        <derivedFrom value="EHR-S_FM_R1.1 DC.2.2.3#2"/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CPS.3.5-03"/>
        <label value="CPS.3.5#03"/>
        <conformance value="SHOULD"/>
        <conditionality value="false"/>
        <requirement
                     value="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 value="EHR-S_FM_R1.1 DC.2.2.3#3"/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CPS.3.5-04"/>
        <label value="CPS.3.5#04"/>
        <conformance value="SHOULD"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHOULD provide the ability to analyze and maintain patients participating in research studies."/>
        <derivedFrom value="EHR-S_FM_R1.1 DC.2.2.3#4"/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CPS.3.5-05"/>
        <label value="CPS.3.5#05"/>
        <conformance value="MAY"/>
        <conditionality value="false"/>
        <requirement
                     value="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 value="EHR-S_FM_R1.1 DC.2.2.3#5"/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CPS.3.5-06"/>
        <label value="CPS.3.5#06"/>
        <conformance value="SHALL"/>
        <conditionality value="false"/>
        <requirement
                     value="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."/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CPS.3.5-07"/>
        <label value="CPS.3.5#07"/>
        <conformance value="SHOULD"/>
        <conditionality value="false"/>
        <requirement
                     value="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."/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CPS.3.5-08"/>
        <label value="CPS.3.5#08"/>
        <conformance value="SHOULD"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHOULD determine patients eligible for known active clinical research protocols as defined by inclusion and exclusion criteria."/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CPS.3.5-09"/>
        <label value="CPS.3.5#09"/>
        <conformance value="SHOULD"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHOULD present information notifying staff of patient's eligibility for known active clinical research protocols as defined by inclusion and exclusion criteria."/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CPS.3.5-10"/>
        <label value="CPS.3.5#10"/>
        <conformance value="SHOULD"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation."/>
      </statement>
    </Requirements>