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 |
{
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-Visit-1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyVisitSoa"
]
},
"language" : "en",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n<div>\n <table class=\"grid dict\">\n \n <tr>\n <th scope=\"row\"><b>Id: </b></th>\n <td style=\"padding-left: 4px;\">H2Q-MC-LZZT-Study-Visit-1</td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Url: </b></th>\n <td style=\"padding-left: 4px;\"><a href=\"PlanDefinition-H2Q-MC-LZZT-Study-Visit-1.html\">H2Q-MC-LZZT Screening Visit</a></td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Version: </b></th>\n <td style=\"padding-left: 4px;\">2.0.0-ballot</td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\">\n <b>\n \n \n PLAC identifier:\n \n \n </b>\n </th>\n <td style=\"padding-left: 4px;\">\n \n <p style=\"margin-bottom: 5px;\">\n <span>H2Q-MC-LZZT-Study-Visit-1</span>\n </p>\n \n </td>\n </tr>\n \n <tr>\n <th scope=\"row\">\n <b>\n \n \n PLAC identifier:\n \n \n </b>\n </th>\n <td style=\"padding-left: 4px;\">\n \n <p style=\"margin-bottom: 5px;\">\n <span>VISIT-1</span>\n </p>\n \n </td>\n </tr>\n \n <tr>\n <th scope=\"row\">\n <b>\n \n \n \n </b>\n </th>\n <td style=\"padding-left: 4px;\">\n \n <p style=\"margin-bottom: 5px;\">\n <span>urn:oid:2.16.840.1.113883.4.642.40.224.34.3</span>\n </p>\n \n </td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Title: </b></th>\n <td style=\"padding-left: 4px;\">H2Q-MC-LZZT Screening Visit</td>\n </tr>\n \n\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Type: </b></th>\n <td style=\"padding-left: 4px;\">\n \n \n \n <p style=\"margin-bottom: 5px;\">\n <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>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>code: </b> <span>clinical-protocol</span>\n </p>\n \n \n \n \n \n </td>\n </tr>\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Date: </b></th>\n <td style=\"padding-left: 4px;\">2022-11-03</td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Publisher: </b></th>\n <td style=\"padding-left: 4px;\">HL7 International / Biomedical Research and Regulation</td>\n </tr>\n \n\n \n\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Jurisdiction: </b></th>\n <td style=\"padding-left: 4px;\">001</td>\n </tr>\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Actions: </b></th>\n <td style=\"padding-left: 4px;\">\n <table class=\"grid-dict\">\n \n <tr>\n <td>\n \n <b> Record Visit Date:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Visit-Date<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Informed Consent:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Informed-Consent<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Patient number assigned:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Patient-number-assigned<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Hachinski 4:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Hachinski-4<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> MMSE 10-23:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-MMSE-10-23<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Physical examination:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Physical-examination<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Medical History:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Medical-History<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Habits - Alcohol:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Habits-Alcohol<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Habits - Caffeine:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Habits-Caffeine<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Habits - Smoking:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Habits-Smoking<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Chest x-ray:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Chest-x-ray<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Vital signs: Height:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-Height-PD<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Vital signs: Weight:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-Weight-PD<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Vital Signs: Temperature:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-Temperature-PD<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Vital Signs: Heart Rate and Blood Pressure:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-HeartRate-BloodPressure<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> ECG:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-ECG<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Placebo TTS test:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Placebo-TTS-test<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> CT Scan:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-CT-Scan<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Concomitant Medications:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Laboratory (Hematology):</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Laboratory-Hemat<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Laboratory (Chemistry):</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Laboratory-Chem<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Laboratory (Urinalysis):</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Laboratory-Urinalysis<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Hemoglobin A1C:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Hemoglobin-A1C<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> ADAS-Cog:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Clinician's Interview-Based Impression of Change:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-CIBIC<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Disability Assessment for Dementia:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-DAD<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Neuropsychiatric Inventory Questionnaire – Revised:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-NPI-X<br/>\n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Adverse events:</b> \n \n <br/>\n \n \n \n \n <b>Then:</b> <i>Definition:</i> ActivityDefinition/H2Q-MC-LZZT-Adverse-events<br/>\n \n \n \n </td>\n </tr>\n \n </table>\n </td>\n </tr>\n \n </table>\n</div>\n</div>"
},
"url" : "http://hl7.org/fhir/uv/vulcan-schedule/PlanDefinition/H2Q-MC-LZZT-Study-Visit-1",
"identifier" : [
{
"use" : "usual",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
"code" : "PLAC"
}
]
},
"value" : "H2Q-MC-LZZT-Study-Visit-1"
},
{
"use" : "usual",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
"code" : "PLAC"
}
]
},
"value" : "VISIT-1"
},
{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.40.224.34.3"
}
],
"version" : "2.0.0-ballot",
"title" : "H2Q-MC-LZZT Screening Visit",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
"code" : "clinical-protocol"
}
]
},
"status" : "active",
"date" : "2022-11-03",
"publisher" : "HL7 International / Biomedical Research and Regulation",
"contact" : [
{
"name" : "HL7 International / Biomedical Research and Regulation",
"telecom" : [
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"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim"
},
{
"system" : "email",
"value" : "biomedrr@lists.hl7.org"
}
]
}
],
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
]
}
],
"action" : [
{
"id" : "VISIT-1-H2Q-MC-LZZT-Visit-Date",
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"id" : "H2Q-MC-LZZT-Informed-Consent",
"title" : "Informed Consent",
"relatedAction" : [
{
"targetId" : "VISIT-1-H2Q-MC-LZZT-Visit-Date",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Informed-Consent"
},
{
"title" : "Patient number assigned",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Patient-number-assigned"
},
{
"title" : "Hachinski 4",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Hachinski-4"
},
{
"title" : "MMSE 10-23",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-MMSE-10-23"
},
{
"title" : "Physical examination",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Physical-examination"
},
{
"title" : "Medical History",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Medical-History"
},
{
"title" : "Habits - Alcohol",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Habits-Alcohol"
},
{
"title" : "Habits - Caffeine",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Habits-Caffeine"
},
{
"title" : "Habits - Smoking",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Habits-Smoking"
},
{
"title" : "Chest x-ray",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Chest-x-ray"
},
{
"title" : "Vital signs: Height",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-Height-PD"
},
{
"title" : "Vital signs: Weight",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-Weight-PD"
},
{
"title" : "Vital Signs: Temperature",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-Temperature-PD"
},
{
"title" : "Vital Signs: Heart Rate and Blood Pressure",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-Signs-HeartRate-BloodPressure"
},
{
"title" : "ECG",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ECG"
},
{
"title" : "Placebo TTS test",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Placebo-TTS-test"
},
{
"title" : "CT Scan",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-CT-Scan"
},
{
"title" : "Concomitant Medications",
"relatedAction" : [
{
"targetId" : "VISIT-1-H2Q-MC-LZZT-Visit-Date",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"
},
{
"title" : "Laboratory (Hematology)",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-Hemat"
},
{
"title" : "Laboratory (Chemistry)",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-Chem"
},
{
"title" : "Laboratory (Urinalysis)",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-Urinalysis"
},
{
"title" : "Hemoglobin A1C",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Hemoglobin-A1C"
},
{
"title" : "ADAS-Cog",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog"
},
{
"title" : "Clinician's Interview-Based Impression of Change",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-CIBIC"
},
{
"title" : "Disability Assessment for Dementia",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-DAD"
},
{
"title" : "Neuropsychiatric Inventory Questionnaire – Revised",
"relatedAction" : [
{
"targetId" : "H2Q-MC-LZZT-Informed-Consent",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-NPI-X"
},
{
"title" : "Adverse events",
"relatedAction" : [
{
"targetId" : "VISIT-1-H2Q-MC-LZZT-Visit-Date",
"relationship" : "after"
}
],
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
}
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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