Clinical Study Schedule of Activities
2.0.0-ballot - STU 2 - Ballot
Clinical Study Schedule of Activities
2.0.0-ballot - STU 2 - Ballot
Clinical Study Schedule of Activities, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/Vulcan-schedule-ig/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
<PlanDefinition xmlns="http://hl7.org/fhir">
<id value="H2Q-MC-LZZT-Study-Visit-1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyVisitSoa"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<div>
<table class="grid dict">
<tr>
<th scope="row"><b>Id: </b></th>
<td style="padding-left: 4px;">H2Q-MC-LZZT-Study-Visit-1</td>
</tr>
<tr>
<th scope="row"><b>Url: </b></th>
<td style="padding-left: 4px;"><a href="PlanDefinition-H2Q-MC-LZZT-Study-Visit-1.html">H2Q-MC-LZZT Screening Visit</a></td>
</tr>
<tr>
<th scope="row"><b>Version: </b></th>
<td style="padding-left: 4px;">2.0.0-ballot</td>
</tr>
<tr>
<th scope="row">
<b>
PLAC identifier:
</b>
</th>
<td style="padding-left: 4px;">
<p style="margin-bottom: 5px;">
<span>H2Q-MC-LZZT-Study-Visit-1</span>
</p>
</td>
</tr>
<tr>
<th scope="row">
<b>
PLAC identifier:
</b>
</th>
<td style="padding-left: 4px;">
<p style="margin-bottom: 5px;">
<span>VISIT-1</span>
</p>
</td>
</tr>
<tr>
<th scope="row">
<b>
</b>
</th>
<td style="padding-left: 4px;">
<p style="margin-bottom: 5px;">
<span>urn:oid:2.16.840.1.113883.4.642.40.224.34.3</span>
</p>
</td>
</tr>
<tr>
<th scope="row"><b>Title: </b></th>
<td style="padding-left: 4px;">H2Q-MC-LZZT Screening Visit</td>
</tr>
<tr>
<th scope="row"><b>Type: </b></th>
<td style="padding-left: 4px;">
<p style="margin-bottom: 5px;">
<b>system: </b> <span><a href="http://terminology.hl7.org/7.1.0/CodeSystem-plan-definition-type.html">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>
</p>
<p style="margin-bottom: 5px;">
<b>code: </b> <span>clinical-protocol</span>
</p>
</td>
</tr>
<tr>
<th scope="row"><b>Date: </b></th>
<td style="padding-left: 4px;">2022-11-03</td>
</tr>
<tr>
<th scope="row"><b>Publisher: </b></th>
<td style="padding-left: 4px;">HL7 International / Biomedical Research and Regulation</td>
</tr>
<tr>
<th scope="row"><b>Jurisdiction: </b></th>
<td style="padding-left: 4px;">001</td>
</tr>
<tr>
<th scope="row"><b>Actions: </b></th>
<td style="padding-left: 4px;">
<table class="grid-dict">
<tr>
<td>
<b> Record Visit Date:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Visit-Date<br/>
</td>
</tr>
<tr>
<td>
<b> Informed Consent:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Informed-Consent<br/>
</td>
</tr>
<tr>
<td>
<b> Patient number assigned:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Patient-number-assigned<br/>
</td>
</tr>
<tr>
<td>
<b> Hachinski 4:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Hachinski-4<br/>
</td>
</tr>
<tr>
<td>
<b> MMSE 10-23:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-MMSE-10-23<br/>
</td>
</tr>
<tr>
<td>
<b> Physical examination:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Physical-examination<br/>
</td>
</tr>
<tr>
<td>
<b> Medical History:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Medical-History<br/>
</td>
</tr>
<tr>
<td>
<b> Habits - Alcohol:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Habits-Alcohol<br/>
</td>
</tr>
<tr>
<td>
<b> Habits - Caffeine:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Habits-Caffeine<br/>
</td>
</tr>
<tr>
<td>
<b> Habits - Smoking:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Habits-Smoking<br/>
</td>
</tr>
<tr>
<td>
<b> Chest x-ray:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Chest-x-ray<br/>
</td>
</tr>
<tr>
<td>
<b> Vital signs: Height:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-Height-PD<br/>
</td>
</tr>
<tr>
<td>
<b> Vital signs: Weight:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-Weight-PD<br/>
</td>
</tr>
<tr>
<td>
<b> Vital Signs: Temperature:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-Temperature-PD<br/>
</td>
</tr>
<tr>
<td>
<b> Vital Signs: Heart Rate and Blood Pressure:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-HeartRate-BloodPressure<br/>
</td>
</tr>
<tr>
<td>
<b> ECG:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-ECG<br/>
</td>
</tr>
<tr>
<td>
<b> Placebo TTS test:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Placebo-TTS-test<br/>
</td>
</tr>
<tr>
<td>
<b> CT Scan:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-CT-Scan<br/>
</td>
</tr>
<tr>
<td>
<b> Concomitant Medications:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications<br/>
</td>
</tr>
<tr>
<td>
<b> Laboratory (Hematology):</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Laboratory-Hemat<br/>
</td>
</tr>
<tr>
<td>
<b> Laboratory (Chemistry):</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Laboratory-Chem<br/>
</td>
</tr>
<tr>
<td>
<b> Laboratory (Urinalysis):</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Laboratory-Urinalysis<br/>
</td>
</tr>
<tr>
<td>
<b> Hemoglobin A1C:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Hemoglobin-A1C<br/>
</td>
</tr>
<tr>
<td>
<b> ADAS-Cog:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog<br/>
</td>
</tr>
<tr>
<td>
<b> Clinician's Interview-Based Impression of Change:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-CIBIC<br/>
</td>
</tr>
<tr>
<td>
<b> Disability Assessment for Dementia:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-DAD<br/>
</td>
</tr>
<tr>
<td>
<b> Neuropsychiatric Inventory Questionnaire – Revised:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-NPI-X<br/>
</td>
</tr>
<tr>
<td>
<b> Adverse events:</b>
<br/>
<b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Adverse-events<br/>
</td>
</tr>
</table>
</td>
</tr>
</table>
</div>
</div>
</text>
<url
value="http://hl7.org/fhir/uv/vulcan-schedule/PlanDefinition/H2Q-MC-LZZT-Study-Visit-1"/>
<identifier>
<use value="usual"/>
<type>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
<code value="PLAC"/>
</coding>
</type>
<value value="H2Q-MC-LZZT-Study-Visit-1"/>
</identifier>
<identifier>
<use value="usual"/>
<type>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
<code value="PLAC"/>
</coding>
</type>
<value value="VISIT-1"/>
</identifier>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.224.34.3"/>
</identifier>
<version value="2.0.0-ballot"/>
<title value="H2Q-MC-LZZT Screening Visit"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/plan-definition-type"/>
<code value="clinical-protocol"/>
</coding>
</type>
<status value="active"/>
<date value="2022-11-03"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International / Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/rcrim"/>
</telecom>
<telecom>
<system value="email"/>
<value value="biomedrr@lists.hl7.org"/>
</telecom>
</contact>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<action id="VISIT-1-H2Q-MC-LZZT-Visit-Date">
<title value="Record Visit Date"/>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-Visit-Date"/>
</action>
<action id="H2Q-MC-LZZT-Informed-Consent">
<title value="Informed Consent"/>
<relatedAction>
<targetId value="VISIT-1-H2Q-MC-LZZT-Visit-Date"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-Informed-Consent"/>
</action>
<action>
<title value="Patient number assigned"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri
value="ActivityDefinition/H2Q-MC-LZZT-Patient-number-assigned"/>
</action>
<action>
<title value="Hachinski 4"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-Hachinski-4"/>
</action>
<action>
<title value="MMSE 10-23"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-MMSE-10-23"/>
</action>
<action>
<title value="Physical examination"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri
value="ActivityDefinition/H2Q-MC-LZZT-Physical-examination"/>
</action>
<action>
<title value="Medical History"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-Medical-History"/>
</action>
<action>
<title value="Habits - Alcohol"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-Habits-Alcohol"/>
</action>
<action>
<title value="Habits - Caffeine"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-Habits-Caffeine"/>
</action>
<action>
<title value="Habits - Smoking"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-Habits-Smoking"/>
</action>
<action>
<title value="Chest x-ray"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-Chest-x-ray"/>
</action>
<action>
<title value="Vital signs: Height"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri
value="ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-Height-PD"/>
</action>
<action>
<title value="Vital signs: Weight"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri
value="ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-Weight-PD"/>
</action>
<action>
<title value="Vital Signs: Temperature"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri
value="ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-Temperature-PD"/>
</action>
<action>
<title value="Vital Signs: Heart Rate and Blood Pressure"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri
value="ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-HeartRate-BloodPressure"/>
</action>
<action>
<title value="ECG"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-ECG"/>
</action>
<action>
<title value="Placebo TTS test"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-Placebo-TTS-test"/>
</action>
<action>
<title value="CT Scan"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-CT-Scan"/>
</action>
<action>
<title value="Concomitant Medications"/>
<relatedAction>
<targetId value="VISIT-1-H2Q-MC-LZZT-Visit-Date"/>
<relationship value="after"/>
</relatedAction>
<definitionUri
value="ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"/>
</action>
<action>
<title value="Laboratory (Hematology)"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-Laboratory-Hemat"/>
</action>
<action>
<title value="Laboratory (Chemistry)"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-Laboratory-Chem"/>
</action>
<action>
<title value="Laboratory (Urinalysis)"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri
value="ActivityDefinition/H2Q-MC-LZZT-Laboratory-Urinalysis"/>
</action>
<action>
<title value="Hemoglobin A1C"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-Hemoglobin-A1C"/>
</action>
<action>
<title value="ADAS-Cog"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog"/>
</action>
<action>
<title value="Clinician's Interview-Based Impression of Change"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-CIBIC"/>
</action>
<action>
<title value="Disability Assessment for Dementia"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-DAD"/>
</action>
<action>
<title value="Neuropsychiatric Inventory Questionnaire – Revised"/>
<relatedAction>
<targetId value="H2Q-MC-LZZT-Informed-Consent"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-NPI-X"/>
</action>
<action>
<title value="Adverse events"/>
<relatedAction>
<targetId value="VISIT-1-H2Q-MC-LZZT-Visit-Date"/>
<relationship value="after"/>
</relatedAction>
<definitionUri value="ActivityDefinition/H2Q-MC-LZZT-Adverse-events"/>
</action>
</PlanDefinition>
IG © 2022+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.vulcan-schedule#2.0.0-ballot based on FHIR 6.0.0-ballot3.
Generated
2026-04-06
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