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

## : POP.10 Manage Population Health Study-Related Identifiers (Function)

Page standards status: Normative

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    <Requirements xmlns="http://hl7.org/fhir">
      <id value="EHRSFMR2-POP.10"/>
      <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>Research or population studies can be distinguished from each other through the proper use of identifiers for key elements. Study key elements may include identifying the study, location where the study is being performed, patient subject of study, and investigator. Identifiers are managed through their lifecycle including capture, maintenance and rendering.</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;">
                POP.10#01
                </td>
                <td style="padding-left: 4px;">
                SHOULD

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHOULD provide the ability to manage unique research identifiers (i.e. sponsor-provided Protocol mnemonic) such that the research study can be identified.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                POP.10#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 manage the site identification number(s) as assigned by the Sponsor.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                POP.10#03
                </td>
                <td style="padding-left: 4px;">
                SHALL

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL provide the ability to manage unique research subject identifiers (e.g., these identifiers could be used as a screening number prior to the subject qualifying for the clinical trial). Note: A given patient may have multiple research subject identifiers if the patient has been on multiple research studies.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                POP.10#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 manage clinical research identifiers (e.g., investigator identifier or visit name) as discrete data elements.</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-POP.10"/>
      <version value="2.1.1"/>
      <name value="POP_10_Manage_Population_Health_Study_Related_Identifiers"/>
      <title
             value="POP.10 Manage Population Health Study-Related Identifiers (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="Manage information that identifies key elements of a research or population study."/>
      <jurisdiction>
        <coding>
          <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
          <code value="001"/>
          <display value="World"/>
        </coding>
      </jurisdiction>
      <purpose
               value="Research or population studies can be distinguished from each other through the proper use of identifiers for key elements. Study key elements may include identifying the study, location where the study is being performed, patient subject of study, and investigator. Identifiers are managed through their lifecycle including capture, maintenance and rendering."/>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-POP.10-01"/>
        <label value="POP.10#01"/>
        <conformance value="SHOULD"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHOULD provide the ability to manage unique research identifiers (i.e. sponsor-provided Protocol mnemonic) such that the research study can be identified."/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-POP.10-02"/>
        <label value="POP.10#02"/>
        <conformance value="SHALL"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHALL provide the ability to manage the site identification number(s) as assigned by the Sponsor."/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-POP.10-03"/>
        <label value="POP.10#03"/>
        <conformance value="SHALL"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHALL provide the ability to manage unique research subject identifiers (e.g., these identifiers could be used as a screening number prior to the subject qualifying for the clinical trial). Note: A given patient may have multiple research subject identifiers if the patient has been on multiple research studies."/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-POP.10-04"/>
        <label value="POP.10#04"/>
        <conformance value="SHOULD"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHOULD provide the ability to manage clinical research identifiers (e.g., investigator identifier or visit name) as discrete data elements."/>
      </statement>
    </Requirements>