0.1.1 - ci-build
ScheduleOfActivityIG - Local Development build (v0.1.1). See the Directory of published versions
{
"resourceType" : "Bundle",
"id" : "H2Q-MC-LZZT-Bundle-2",
"type" : "transaction",
"entry" : [
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-Visit-1",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: -14</p><p><b>identifier</b>: PLAC: VISIT-1 (USUAL), OID: SE.SCREENING_VISIT (SECONDARY)</p><p><b>status</b>: active</p><blockquote><p><b>action</b></p><p><b>title</b>: Record Visit Date</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Informed Consent </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Informed-Consent</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Patient number assigned </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Patient-number-assigned</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Hachinski 4 </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Hachinski-4</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: MMSE 10-23 </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-MMSE-10-23</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Physical examination </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Physical-examination</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Medical History </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Medical-History</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Habits - Alcohol</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Habits-Alcohol</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Habits - Caffeine</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Habits-Caffeine</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Habits - Smoking</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Habits-Smoking</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Chest x-ray </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Chest-x-ray</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Vital signs/Temperature </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ECG </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ECG</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Placebo TTS test </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Placebo-TTS-test</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: CT Scan</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-CT-Scan</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Concomitant Medications </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Chem/Hemat)</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Urinalysis) </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Urinalysis)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Hemoglobin A1C </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Hemoglobin-A1C</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ADAS-Cog </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: CIBIC+ </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-CIBIC+</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: DAD </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-DAD</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: NPI-X </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-NPI-X</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Adverse events </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Adverse-events</code></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : -14
}
],
"identifier" : [
{
"use" : "usual",
"type" : {
"coding" : [
{
"code" : "PLAC"
}
]
},
"value" : "VISIT-1"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
],
"text" : "OID"
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.SCREENING_VISIT"
}
],
"status" : "active",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"title" : "Informed Consent ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Informed-Consent"
},
{
"title" : "Patient number assigned ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Patient-number-assigned"
},
{
"title" : "Hachinski 4 ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Hachinski-4"
},
{
"title" : "MMSE 10-23 ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-MMSE-10-23"
},
{
"title" : "Physical examination ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Physical-examination"
},
{
"title" : "Medical History ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Medical-History"
},
{
"title" : "Habits - Alcohol",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Habits-Alcohol"
},
{
"title" : "Habits - Caffeine",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Habits-Caffeine"
},
{
"title" : "Habits - Smoking",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Habits-Smoking"
},
{
"title" : "Chest x-ray ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Chest-x-ray"
},
{
"title" : "Vital signs/Temperature ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature"
},
{
"title" : "ECG ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ECG"
},
{
"title" : "Placebo TTS test ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Placebo-TTS-test"
},
{
"title" : "CT Scan",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-CT-Scan"
},
{
"title" : "Concomitant Medications ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"
},
{
"title" : "Laboratory (Chem/Hemat)",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)"
},
{
"title" : "Laboratory (Urinalysis) ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Urinalysis)"
},
{
"title" : "Hemoglobin A1C ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Hemoglobin-A1C"
},
{
"title" : "ADAS-Cog ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog"
},
{
"title" : "CIBIC+ ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-CIBIC+"
},
{
"title" : "DAD ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-DAD"
},
{
"title" : "NPI-X ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-NPI-X"
},
{
"title" : "Adverse events ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-Visit-2",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: 0</p><p><b>identifier</b>: PLAC: VISIT-2 (USUAL), OID: SE.AMB_ECG_VISIT (SECONDARY)</p><p><b>status</b>: active</p><blockquote><p><b>action</b></p><p><b>title</b>: Record Visit Date</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Vital signs/Temperature </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Ambulatory ECG placed </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Ambulatory-ECG-placed</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Adverse events </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Adverse-events</code></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : 0
}
],
"identifier" : [
{
"use" : "usual",
"type" : {
"coding" : [
{
"code" : "PLAC"
}
]
},
"value" : "VISIT-2"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
]
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.AMB_ECG_VISIT"
}
],
"status" : "active",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"title" : "Vital signs/Temperature ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature"
},
{
"title" : "Ambulatory ECG placed ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Ambulatory-ECG-placed"
},
{
"title" : "Adverse events ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-Visit-3",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: 0</p><p><b>identifier</b>: PLAC: VISIT-3 (USUAL), OID: SE.RANDOMIZATION_VISIT (SECONDARY)</p><p><b>status</b>: active</p><blockquote><p><b>action</b></p><p><b>title</b>: Record Visit Date</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Patient randomized </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Patient-randomized</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Vital signs/Temperature </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Ambulatory ECG removed </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Ambulatory-ECG-removed</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Concomitant Medications </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Urinalysis) </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Urinalysis)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Plasma Specimen </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Plasma-Specimen</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Study drug record </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Study-drug-record</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ADAS-Cog </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: CIBIC+ </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-CIBIC+</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: DAD </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-DAD</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: NPI-X </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-NPI-X</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Adverse events </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Adverse-events</code></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : 0
}
],
"identifier" : [
{
"use" : "usual",
"type" : {
"coding" : [
{
"code" : "PLAC"
}
]
},
"value" : "VISIT-3"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
]
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.RANDOMIZATION_VISIT"
}
],
"status" : "active",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"title" : "Patient randomized ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Patient-randomized"
},
{
"title" : "Vital signs/Temperature ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature"
},
{
"title" : "Ambulatory ECG removed ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Ambulatory-ECG-removed"
},
{
"title" : "Concomitant Medications ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"
},
{
"title" : "Laboratory (Urinalysis) ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Urinalysis)"
},
{
"title" : "Plasma Specimen ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Plasma-Specimen"
},
{
"title" : "Study drug record ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Study-drug-record"
},
{
"title" : "ADAS-Cog ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog"
},
{
"title" : "CIBIC+ ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-CIBIC+"
},
{
"title" : "DAD ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-DAD"
},
{
"title" : "NPI-X ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-NPI-X"
},
{
"title" : "Adverse events ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-Visit-4",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: 14</p><p><b>identifier</b>: PLAC: VISIT-4 (USUAL), OID: SE.TRT_VISIT_01 (SECONDARY)</p><p><b>status</b>: active</p><blockquote><p><b>action</b></p><p><b>title</b>: Record Visit Date</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Apo E genotyping </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Apo-E-genotyping</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Vital signs/Temperature </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ECG </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ECG</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Concomitant Medications </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Chem/Hemat)</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Plasma Specimen </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Plasma-Specimen</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Study drug record </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Study-drug-record</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: NPI-X </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-NPI-X</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Adverse events </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Adverse-events</code></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : 14
}
],
"identifier" : [
{
"use" : "usual",
"type" : {
"coding" : [
{
"code" : "PLAC"
}
]
},
"value" : "VISIT-4"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
]
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.TRT_VISIT_01"
}
],
"status" : "active",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"title" : "Apo E genotyping ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Apo-E-genotyping"
},
{
"title" : "Vital signs/Temperature ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature"
},
{
"title" : "ECG ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ECG"
},
{
"title" : "Concomitant Medications ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"
},
{
"title" : "Laboratory (Chem/Hemat)",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)"
},
{
"title" : "Plasma Specimen ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Plasma-Specimen"
},
{
"title" : "Study drug record ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Study-drug-record"
},
{
"title" : "NPI-X ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-NPI-X"
},
{
"title" : "Adverse events ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-Visit-5",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: 21</p><p><b>identifier</b>: PLAC: VISIT-5 (USUAL), OID: SE.TRT_VISIT_02 (SECONDARY)</p><p><b>status</b>: active</p><blockquote><p><b>action</b></p><p><b>title</b>: Record Visit Date</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Vital signs/Temperature </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ECG </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ECG</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Concomitant Medications </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Chem/Hemat)</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Plasma Specimen </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Plasma-Specimen</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Study drug record </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Study-drug-record</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: NPI-X </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-NPI-X</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Adverse events </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Adverse-events</code></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : 21
}
],
"identifier" : [
{
"use" : "usual",
"type" : {
"coding" : [
{
"code" : "PLAC"
}
]
},
"value" : "VISIT-5"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
]
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.TRT_VISIT_02"
}
],
"status" : "active",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"title" : "Vital signs/Temperature ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature"
},
{
"title" : "ECG ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ECG"
},
{
"title" : "Concomitant Medications ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"
},
{
"title" : "Laboratory (Chem/Hemat)",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)"
},
{
"title" : "Plasma Specimen ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Plasma-Specimen"
},
{
"title" : "Study drug record ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Study-drug-record"
},
{
"title" : "NPI-X ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-NPI-X"
},
{
"title" : "Adverse events ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-Visit-6",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: 28</p><p><b>identifier</b>: id: VISIT-6, OID: SE.TRT_VISIT_03 (SECONDARY)</p><p><b>status</b>: active</p><h3>Actions</h3><table class=\"grid\"><tr><td>-</td><td><b>Title</b></td><td><b>Definition[x]</b></td></tr><tr><td>*</td><td>Record Visit Date</td><td><code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></td></tr></table></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : 28
}
],
"identifier" : [
{
"value" : "VISIT-6"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
]
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.TRT_VISIT_03"
}
],
"status" : "active",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-Visit-7",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: 42</p><p><b>identifier</b>: id: VISIT-7, OID: SE.TRT_VISIT_04 (SECONDARY)</p><p><b>status</b>: active</p><blockquote><p><b>action</b></p><p><b>title</b>: Record Visit Date</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Vital signs/Temperature </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ECG </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ECG</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Concomitant Medications </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Chem/Hemat)</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Plasma Specimen </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Plasma-Specimen</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Study drug record </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Study-drug-record</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: NPI-X </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-NPI-X</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Adverse events </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Adverse-events</code></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : 42
}
],
"identifier" : [
{
"value" : "VISIT-7"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
]
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.TRT_VISIT_04"
}
],
"status" : "active",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"title" : "Vital signs/Temperature ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature"
},
{
"title" : "ECG ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ECG"
},
{
"title" : "Concomitant Medications ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"
},
{
"title" : "Laboratory (Chem/Hemat)",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)"
},
{
"title" : "Plasma Specimen ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Plasma-Specimen"
},
{
"title" : "Study drug record ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Study-drug-record"
},
{
"title" : "NPI-X ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-NPI-X"
},
{
"title" : "Adverse events ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-Visit-8",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: 56</p><p><b>identifier</b>: id: VISIT-8, OID: SE.TRT_VISIT_05 (SECONDARY)</p><p><b>status</b>: active</p><blockquote><p><b>action</b></p><p><b>title</b>: Record Visit Date</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Vital signs/Temperature </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ECG </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ECG</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Concomitant Medications </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Chem/Hemat)</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Study drug record </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Study-drug-record</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ADAS-Cog </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: CIBIC+ </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-CIBIC+</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: DAD </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-DAD</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: NPI-X </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-NPI-X</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Adverse events </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Adverse-events</code></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : 56
}
],
"identifier" : [
{
"value" : "VISIT-8"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
]
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.TRT_VISIT_05"
}
],
"status" : "active",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"title" : "Vital signs/Temperature ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature"
},
{
"title" : "ECG ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ECG"
},
{
"title" : "Concomitant Medications ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"
},
{
"title" : "Laboratory (Chem/Hemat)",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)"
},
{
"title" : "Study drug record ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Study-drug-record"
},
{
"title" : "ADAS-Cog ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog"
},
{
"title" : "CIBIC+ ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-CIBIC+"
},
{
"title" : "DAD ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-DAD"
},
{
"title" : "NPI-X ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-NPI-X"
},
{
"title" : "Adverse events ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-Visit-9",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: 84</p><p><b>identifier</b>: id: VISIT-9, OID: SE.TRT_VISIT_06 (SECONDARY)</p><p><b>type</b>: <span title=\"Codes: \">clinical-protocol</span></p><p><b>status</b>: retired</p><blockquote><p><b>action</b></p><p><b>title</b>: Record Visit Date</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Vital signs/Temperature </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ECG </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ECG</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Concomitant Medications </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Chem/Hemat)</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Urinalysis) </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Urinalysis)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Plasma Specimen </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Plasma-Specimen</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Study drug record </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Study-drug-record</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: TTS Acceptability Survey</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-TTS-Acceptability-Survey</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ADAS-Cog </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: CIBIC+ </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-CIBIC+</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: DAD </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-DAD</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: NPI-X </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-NPI-X</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Adverse events </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Adverse-events</code></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : 84
}
],
"identifier" : [
{
"value" : "VISIT-9"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
]
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.TRT_VISIT_06"
}
],
"type" : {
"coding" : [
{
"code" : "clinical-protocol"
}
]
},
"status" : "retired",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"title" : "Vital signs/Temperature ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature"
},
{
"title" : "ECG ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ECG"
},
{
"title" : "Concomitant Medications ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"
},
{
"title" : "Laboratory (Chem/Hemat)",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)"
},
{
"title" : "Laboratory (Urinalysis) ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Urinalysis)"
},
{
"title" : "Plasma Specimen ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Plasma-Specimen"
},
{
"title" : "Study drug record ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Study-drug-record"
},
{
"title" : "TTS Acceptability Survey",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-TTS-Acceptability-Survey"
},
{
"title" : "ADAS-Cog ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog"
},
{
"title" : "CIBIC+ ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-CIBIC+"
},
{
"title" : "DAD ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-DAD"
},
{
"title" : "NPI-X ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-NPI-X"
},
{
"title" : "Adverse events ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-Visit-10",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: 112</p><p><b>identifier</b>: id: VISIT-10, OID: SE.TRT_VISIT_07 (SECONDARY)</p><p><b>status</b>: active</p><blockquote><p><b>action</b></p><p><b>title</b>: Record Visit Date</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Vital signs/Temperature </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ECG </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ECG</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Concomitant Medications </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Chem/Hemat)</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Urinalysis) </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Urinalysis)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Plasma Specimen </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Plasma-Specimen</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Study drug record </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Study-drug-record</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: TTS Acceptability Survey</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-TTS-Acceptability-Survey</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ADAS-Cog </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: CIBIC+ </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-CIBIC+</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: DAD </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-DAD</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: NPI-X </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-NPI-X</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Adverse events </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Adverse-events</code></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : 112
}
],
"identifier" : [
{
"value" : "VISIT-10"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
]
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.TRT_VISIT_07"
}
],
"status" : "active",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"title" : "Vital signs/Temperature ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature"
},
{
"title" : "ECG ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ECG"
},
{
"title" : "Concomitant Medications ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"
},
{
"title" : "Laboratory (Chem/Hemat)",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)"
},
{
"title" : "Laboratory (Urinalysis) ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Urinalysis)"
},
{
"title" : "Plasma Specimen ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Plasma-Specimen"
},
{
"title" : "Study drug record ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Study-drug-record"
},
{
"title" : "TTS Acceptability Survey",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-TTS-Acceptability-Survey"
},
{
"title" : "ADAS-Cog ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog"
},
{
"title" : "CIBIC+ ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-CIBIC+"
},
{
"title" : "DAD ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-DAD"
},
{
"title" : "NPI-X ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-NPI-X"
},
{
"title" : "Adverse events ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-Visit-11",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: 140</p><p><b>identifier</b>: id: VISIT-11, OID: SE.TRT_VISIT_08 (SECONDARY)</p><p><b>status</b>: active</p><blockquote><p><b>action</b></p><p><b>title</b>: Record Visit Date</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Vital signs/Temperature </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ECG </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ECG</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Concomitant Medications </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Chem/Hemat)</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Urinalysis) </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Urinalysis)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Plasma Specimen </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Plasma-Specimen</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Study drug record </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Study-drug-record</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ADAS-Cog </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: CIBIC+ </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-CIBIC+</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: DAD </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-DAD</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: NPI-X </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-NPI-X</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Adverse events </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Adverse-events</code></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : 140
}
],
"identifier" : [
{
"value" : "VISIT-11"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
]
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.TRT_VISIT_08"
}
],
"status" : "active",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"title" : "Vital signs/Temperature ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature"
},
{
"title" : "ECG ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ECG"
},
{
"title" : "Concomitant Medications ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"
},
{
"title" : "Laboratory (Chem/Hemat)",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)"
},
{
"title" : "Laboratory (Urinalysis) ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Urinalysis)"
},
{
"title" : "Plasma Specimen ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Plasma-Specimen"
},
{
"title" : "Study drug record ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Study-drug-record"
},
{
"title" : "ADAS-Cog ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog"
},
{
"title" : "CIBIC+ ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-CIBIC+"
},
{
"title" : "DAD ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-DAD"
},
{
"title" : "NPI-X ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-NPI-X"
},
{
"title" : "Adverse events ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-Visit-12",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: 168</p><p><b>identifier</b>: id: VISIT-12, OID: SE.TRT_VISIT_09 (SECONDARY)</p><p><b>status</b>: active</p><blockquote><p><b>action</b></p><p><b>title</b>: Record Visit Date</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Vital signs/Temperature </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ECG </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ECG</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Concomitant Medications </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Chem/Hemat)</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Urinalysis) </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Urinalysis)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Study drug record </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Study-drug-record</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ADAS-Cog </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: CIBIC+ </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-CIBIC+</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: DAD </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-DAD</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: NPI-X </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-NPI-X</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Adverse events </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Adverse-events</code></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : 168
}
],
"identifier" : [
{
"value" : "VISIT-12"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
]
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.TRT_VISIT_09"
}
],
"status" : "active",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"title" : "Vital signs/Temperature ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature"
},
{
"title" : "ECG ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ECG"
},
{
"title" : "Concomitant Medications ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"
},
{
"title" : "Laboratory (Chem/Hemat)",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)"
},
{
"title" : "Laboratory (Urinalysis) ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Urinalysis)"
},
{
"title" : "Study drug record ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Study-drug-record"
},
{
"title" : "ADAS-Cog ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog"
},
{
"title" : "CIBIC+ ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-CIBIC+"
},
{
"title" : "DAD ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-DAD"
},
{
"title" : "NPI-X ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-NPI-X"
},
{
"title" : "Adverse events ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-Visit-13",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: 182</p><p><b>identifier</b>: PLAC: VISIT-13 (USUAL), OID: SE.TRT_VISIT_10 (SECONDARY)</p><p><b>status</b>: active</p><blockquote><p><b>action</b></p><p><b>title</b>: Record Visit Date</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Physical examination </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Physical-examination</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Vital signs/Temperature </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ECG </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ECG</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Concomitant Medications </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Chem/Hemat)</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Study drug record </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Study-drug-record</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: TTS Acceptability Survey</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-TTS-Acceptability-Survey</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: NPI-X </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-NPI-X</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Adverse events </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Adverse-events</code></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : 182
}
],
"identifier" : [
{
"use" : "usual",
"type" : {
"coding" : [
{
"code" : "PLAC"
}
]
},
"value" : "VISIT-13"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
]
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.TRT_VISIT_10"
}
],
"status" : "active",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"title" : "Physical examination ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Physical-examination"
},
{
"title" : "Vital signs/Temperature ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature"
},
{
"title" : "ECG ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ECG"
},
{
"title" : "Concomitant Medications ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"
},
{
"title" : "Laboratory (Chem/Hemat)",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)"
},
{
"title" : "Study drug record ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Study-drug-record"
},
{
"title" : "TTS Acceptability Survey",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-TTS-Acceptability-Survey"
},
{
"title" : "NPI-X ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-NPI-X"
},
{
"title" : "Adverse events ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-ET-14",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: 0</p><p><b>identifier</b>: PLAC: ET-14 (USUAL), OID: SE.EARLY_TERM_VISIT (SECONDARY)</p><p><b>status</b>: active</p><blockquote><p><b>action</b></p><p><b>title</b>: Record Visit Date</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ET</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ET</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Physical examination </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Physical-examination</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Vital signs/Temperature </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ECG </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ECG</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Concomitant Medications </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Chem/Hemat)</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Laboratory (Urinalysis) </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Urinalysis)</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Study drug record </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Study-drug-record</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: TTS Acceptability Survey</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-TTS-Acceptability-Survey</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ADAS-Cog </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: CIBIC+ </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-CIBIC+</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: DAD </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-DAD</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: NPI-X </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-NPI-X</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Adverse events </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Adverse-events</code></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : 0
}
],
"identifier" : [
{
"use" : "usual",
"type" : {
"coding" : [
{
"code" : "PLAC"
}
]
},
"value" : "ET-14"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
]
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.EARLY_TERM_VISIT"
}
],
"status" : "active",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"title" : "ET",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ET"
},
{
"title" : "Physical examination ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Physical-examination"
},
{
"title" : "Vital signs/Temperature ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature"
},
{
"title" : "ECG ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ECG"
},
{
"title" : "Concomitant Medications ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"
},
{
"title" : "Laboratory (Chem/Hemat)",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Chem/Hemat)"
},
{
"title" : "Laboratory (Urinalysis) ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Laboratory-(Urinalysis)"
},
{
"title" : "Study drug record ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Study-drug-record"
},
{
"title" : "TTS Acceptability Survey",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-TTS-Acceptability-Survey"
},
{
"title" : "ADAS-Cog ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog"
},
{
"title" : "CIBIC+ ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-CIBIC+"
},
{
"title" : "DAD ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-DAD"
},
{
"title" : "NPI-X ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-NPI-X"
},
{
"title" : "Adverse events ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "H2Q-MC-LZZT-Study-RT-15",
"meta" : {
"profile" : [
"http://example.org/br-and-r/soa/StructureDefinition/SOA-PlanDefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Planned Study Day of Visit</b>: 0</p><p><b>identifier</b>: PLAC: RT-15 (USUAL), OID: SE.RETRIEVAL_TERM_VISIT (SECONDARY)</p><p><b>status</b>: active</p><blockquote><p><b>action</b></p><p><b>title</b>: Record Visit Date</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Visit-Date</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: RT</p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-RT</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Vital signs/Temperature </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Concomitant Medications </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: ADAS-Cog </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: CIBIC+ </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-CIBIC+</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: DAD </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-DAD</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: NPI-X </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-NPI-X</code></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Adverse events </p><p><b>definition</b>: <code>ActivityDefinition/H2Q-MC-LZZT-Adverse-events</code></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://example.org/br-and-r/soa/StructureDefinition/planned-visit-study-day",
"valueInteger" : 0
}
],
"identifier" : [
{
"use" : "usual",
"type" : {
"coding" : [
{
"code" : "PLAC"
}
]
},
"value" : "RT-15"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://www.cdisc.org/ns/odm/v1.3#",
"display" : "OID"
}
]
},
"system" : "http://www.cdisc.org/ns/odm/v1.3/StudyDef#",
"value" : "SE.RETRIEVAL_TERM_VISIT"
}
],
"status" : "active",
"action" : [
{
"title" : "Record Visit Date",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Visit-Date"
},
{
"title" : "RT",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-RT"
},
{
"title" : "Vital signs/Temperature ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Vital-signs/Temperature"
},
{
"title" : "Concomitant Medications ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Concomitant-Medications"
},
{
"title" : "ADAS-Cog ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-ADAS-Cog"
},
{
"title" : "CIBIC+ ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-CIBIC+"
},
{
"title" : "DAD ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-DAD"
},
{
"title" : "NPI-X ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-NPI-X"
},
{
"title" : "Adverse events ",
"definitionUri" : "ActivityDefinition/H2Q-MC-LZZT-Adverse-events"
}
]
},
"request" : {
"method" : "POST",
"url" : "PlanDefinition"
}
},
{
"resource" : {
"resourceType" : "Group",
"id" : "H2Q-MC-LZZT-ResearchStudy-Inclusion",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>type</b>: person</p><p><b>actual</b>: false</p><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Males and postmenopausal females at least 50 years of age.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Diagnosis of probable AD as defined by National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer’s Disease and Related Disorders Association (ADRDA) guidelines</span></p><p><b>value</b>: true</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">MMSE score of 10 to 23.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Hachinski Ischemic Scale score of ≤4</span></p><p><b>value</b>: true</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">CNS imaging (CT scan or MRI of brain) compatible with AD within past 1 year.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Investigator has obtained informed consent signed by the patient (and/or legal representative) and by the caregiver.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Geographic proximity to investigator’s site that allows adequate follow-up.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A reliable caregiver who is in frequent or daily contact with the patient and who will accompany the patient to the office and/or be available by telephone at designated times, will monitor administration of prescribed medications, and will be responsible for the overall care of the patient at home. The caregiver and the patient must be able to communicate in English and willing to comply with 26 weeks of transdermal therapy.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: false</p></blockquote></div>"
},
"type" : "person",
"actual" : false,
"characteristic" : [
{
"code" : {
"text" : "Males and postmenopausal females at least 50 years of age."
},
"valueBoolean" : true,
"exclude" : false
},
{
"code" : {
"text" : "Diagnosis of probable AD as defined by National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer’s Disease and Related Disorders Association (ADRDA) guidelines"
},
"valueBoolean" : true,
"exclude" : false
},
{
"code" : {
"text" : "MMSE score of 10 to 23."
},
"valueBoolean" : true,
"exclude" : false
},
{
"code" : {
"text" : "Hachinski Ischemic Scale score of ≤4"
},
"valueBoolean" : true,
"exclude" : false
},
{
"code" : {
"text" : "CNS imaging (CT scan or MRI of brain) compatible with AD within past 1 year."
},
"valueBoolean" : true,
"exclude" : false
},
{
"code" : {
"text" : "Investigator has obtained informed consent signed by the patient (and/or legal representative) and by the caregiver."
},
"valueBoolean" : true,
"exclude" : false
},
{
"code" : {
"text" : "Geographic proximity to investigator’s site that allows adequate follow-up."
},
"valueBoolean" : true,
"exclude" : false
},
{
"code" : {
"text" : "A reliable caregiver who is in frequent or daily contact with the patient and who will accompany the patient to the office and/or be available by telephone at designated times, will monitor administration of prescribed medications, and will be responsible for the overall care of the patient at home. The caregiver and the patient must be able to communicate in English and willing to comply with 26 weeks of transdermal therapy."
},
"valueBoolean" : true,
"exclude" : false
}
]
},
"request" : {
"method" : "POST",
"url" : "Group"
}
},
{
"resource" : {
"resourceType" : "Group",
"id" : "H2Q-MC-LZZT-ResearchStudy-Exclusion",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>type</b>: person</p><p><b>actual</b>: false</p><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Persons who have previously completed or withdrawn from this study or any other study investigating xanomeline TTS or the oral formulation of xanomeline.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Use of any investigational agent or approved Alzheimer’s therapeutic medication within 30 days prior to enrollment into the study.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Serious illness which required hospitalization within 3 months of screening.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Stroke or vascular dementia documented by clinical history and/or radiographic findings interpretable by the investigator as indicative of these disorders</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Seizure disorder other than simple childhood febrile seizures</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Severe head trauma resulting in protracted loss of consciousness within the last 5 years, or multiple episodes of head trauma</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Parkinson’s disease</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Multiple sclerosis</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Amyotrophic lateral sclerosis</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Myasthenia gravis</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Episode of depression meeting DSM-IV criteria within 3 months of screening.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Schizophrenia.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Bipolar Disease.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Ethanol or psychoactive drug abuse or dependence.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history of syncope within the last 5 years.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Evidence from ECG recording of Left bundle branch block.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Evidence from ECG recording of Bradycardia ≤50 beats per minute</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Evidence from ECG recording of Sinus pauses >2 seconds</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Evidence from ECG recording of Second or third degree heart block unless treated with a pacemaker</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Evidence from ECG recording of Wolff-Parkinson-White syndrome</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Evidence from ECG recording of Sustained supraventricular tachyarrhythmia including SVT≥10 sec, atrial fibrillation, atrial flutter.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Evidence from ECG recording of Ventricular tachycardia at a rate of ≥120 beats per minute lasting ≥10 seconds.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Clinically significant arrhythmia</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Symptomatic sick sinus syndrome not treated with a pacemaker</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Congestive heart failure refractory to treatment</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Angina except angina controlled with PRN nitroglycerin</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Resting heart rate <50 or >100 beats per minute, on physical exam</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Uncontrolled hypertension.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of a serious gastrointestinal disorder</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote></div>"
},
"type" : "person",
"actual" : false,
"characteristic" : [
{
"code" : {
"text" : "Persons who have previously completed or withdrawn from this study or any other study investigating xanomeline TTS or the oral formulation of xanomeline."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Use of any investigational agent or approved Alzheimer’s therapeutic medication within 30 days prior to enrollment into the study."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Serious illness which required hospitalization within 3 months of screening."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Stroke or vascular dementia documented by clinical history and/or radiographic findings interpretable by the investigator as indicative of these disorders"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Seizure disorder other than simple childhood febrile seizures"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Severe head trauma resulting in protracted loss of consciousness within the last 5 years, or multiple episodes of head trauma"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Parkinson’s disease"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Multiple sclerosis"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Amyotrophic lateral sclerosis"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Myasthenia gravis"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Episode of depression meeting DSM-IV criteria within 3 months of screening."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history within the last 5 years of Schizophrenia."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history within the last 5 years of Bipolar Disease."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history within the last 5 years of Ethanol or psychoactive drug abuse or dependence."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history of syncope within the last 5 years."
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