ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
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| Active as of 2024-11-26 |
<Requirements xmlns="http://hl7.org/fhir">
<id value="EHRSFMR2.1-CPS.3.5"/>
<meta>
<profile value="http://hl7.org/ehrs/StructureDefinition/FMFunction"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<span id="description"><b>Statement <a href="https://hl7.org/fhir/versions.html#std-process" title="Normative Content" class="normative-flag">N</a>:</b> <div><p>Provide support for the management of patients enrolled in research protocols.</p>
</div></span>
<span id="purpose"><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></span>
<span id="requirements"><b>Criteria <a href="https://hl7.org/fhir/versions.html#std-process" title="Normative Content" class="normative-flag">N</a>:</b></span>
<table id="statements" class="grid dict">
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.5#01</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL provide the ability to present protocols for patients enrolled in research studies.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.5#02</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL provide the ability to capture, maintain and render research study protocols.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.5#03</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD conform to function [[AS.9.1]] (Support Financial Plan Enrollment), to enable participation in research studies.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.5#04</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD provide the ability to analyze and maintain patients participating in research studies.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.5#05</span>
</td>
<td style="padding-left: 4px;">
<span>MAY</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><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></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.5#06</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL conform to function [[CP.3.3]] (Manage Clinical Documents and Notes) to capture patient condition and response to treatment.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.5#07</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><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></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.5#08</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD determine patients eligible for known active clinical research protocols as defined by inclusion and exclusion criteria.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.5#09</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><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></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.5#10</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-CPS.3.5"/>
<version value="2.1.0"/>
<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="2024-11-26T16:30:50+00:00"/>
<publisher value="EHR WG"/>
<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/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-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/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-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/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-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]] (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/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-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/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-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/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-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]] (Manage Clinical Documents and Notes) to capture patient condition and response to treatment."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-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/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-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/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-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/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-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>