STU 3 Candidate
This page is part of the FHIR Specification (v1.4.0: STU 3 Ballot 3). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
Study protocol example
{
"resourceType": "Protocol",
"id": "study",
"text": {
"status": "generated",
"div": "<div>\n\t\t\t<p>\n\t\t\t\t<b>id: </b>study, </p>\n\t\t\t<p>\n\t\t\t\t<b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#arm arm-dose1, </p>\n\t\t\t<p>\n\t\t\t\t<b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#arm arm-dose2, </p>\n\t\t\t<p>\n\t\t\t\t<b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#epoch epoch-screening, </p>\n\t\t\t<p>\n\t\t\t\t<b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#epoch epoch-single-blind-run-in, </p>\n\t\t\t<p>\n\t\t\t\t<b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#epoch epoch-treatment-phase, </p>\n\t\t\t<p>\n\t\t\t\t<b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#epoch epoch-follow-up, </p>\n\t\t\t<p>\n\t\t\t\t<b>status: </b>active, </p>\n\t\t\t<p>\n\t\t\t\t<b>type: </b>study, </p>\n\t\t\t<p>\n\t\t\t\t<b>purpose: </b>Defines the execution of study AD-4833PNFP-341, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>SCRN, <b>description: </b>Screen, <b>precondition: </b>, <b>description: </b>Informed Consent, <b>exit: </b>, <b>description: </b>Screening assessments complete, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armAssignment, <b>name: </b>SBRI, <b>description: </b>Single Blind Run-In, <b>duration: </b>, <b>value: </b>1, <b>system: </b>http://unitsofmeasure.org, <b>code: </b>wk, <b>precondition: </b>, <b>description: </b>Initial Single Blind Placebo dose, <b>exit: </b>, <b>description: </b>1 week after start of Element, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>DOSE 1, <b>description: </b>Administer 0.5mg [Drug A] QD, <b>duration: </b>, <b>value: </b>30, <b>system: </b>http://unitsofmeasure.org, <b>code: </b>wk, <b>precondition: </b>, <b>description: </b>First dose of treatment where total drug dose of [Drug A] per day is 0.5 mg., <b>exit: </b>, <b>description: </b>30 weeks after start of Element, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>FLWUP, <b>description: </b>Follow-Up, <b>precondition: </b>, <b>description: </b>Last dose of treatment, <b>exit: </b>, <b>description: </b>2 weeks after start of Element, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>SCRN, <b>description: </b>Screen, <b>precondition: </b>, <b>description: </b>Informed Consent, <b>exit: </b>, <b>description: </b>Screening assessments complete, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armAssignment, <b>name: </b>SBRI, <b>description: </b>Single Blind Run-In, <b>duration: </b>, <b>value: </b>1, <b>system: </b>http://unitsofmeasure.org, <b>code: </b>wk, <b>precondition: </b>, <b>description: </b>First dose of Single Blind Placebo, <b>exit: </b>, <b>description: </b>1 week after start of Element, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>1.0 mg Dose, <b>description: </b>Administer 1.0 mg [Drug A] QD, <b>duration: </b>, <b>value: </b>30, <b>system: </b>http://unitsofmeasure.org, <b>code: </b>wk, <b>precondition: </b>, <b>description: </b>Intial dose of treatment where total drug dose of [Drug A] per day is 1.0 mg., <b>exit: </b>, <b>description: </b>30 weeks after start of Element, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.arm, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>FLWUP, <b>description: </b>Follow-Up, <b>precondition: </b>, <b>description: </b>Last dose of treatment, <b>exit: </b>, <b>description: </b>2 weeks after start of Element, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>VISIT 1, <b>precondition: </b>, <b>description: </b>Screening, <b>activity: </b>, <b>detail: </b>, <b>category: </b>encounter, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>VISIT 2, <b>precondition: </b>, <b>description: </b>single-blind placebo start, <b>activity: </b>, <b>detail: </b>, <b>category: </b>encounter, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>VISIT 3, <b>precondition: </b>, <b>description: </b>Treatment start, <b>activity: </b>, <b>detail: </b>, <b>category: </b>encounter, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>VISIT 4, <b>precondition: </b>, <b>description: </b>5 weeks after treatment start, <b>activity: </b>, <b>detail: </b>, <b>category: </b>encounter, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>VISIT 5, <b>precondition: </b>, <b>description: </b>10 weeks after treatment start, <b>activity: </b>, <b>detail: </b>, <b>category: </b>encounter, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>VISIT 6, <b>precondition: </b>, <b>description: </b>15 weeks after treatment start, <b>activity: </b>, <b>detail: </b>, <b>category: </b>encounter, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>VISIT 7, <b>precondition: </b>, <b>description: </b>20 weeks after treatment start, <b>activity: </b>, <b>detail: </b>, <b>category: </b>encounter, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>VISIT 8, <b>precondition: </b>, <b>description: </b>25 weeks after treatment start, <b>activity: </b>, <b>detail: </b>, <b>category: </b>encounter, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>VISIT 9, <b>precondition: </b>, <b>description: </b>30 weeks after treatment start, <b>activity: </b>, <b>detail: </b>, <b>category: </b>encounter, </p>\n\t\t\t<p>\n\t\t\t\t<b>step: </b>, <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence, <b>name: </b>VISIT 10, <b>precondition: </b>, <b>description: </b>start of follow-up, <b>activity: </b>, <b>detail: </b>, <b>category: </b>encounter, </p>\n\t\t</div>"
},
"extension": [
{
"id": "arm-dose1",
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#arm.name",
"valueString": "0.5 mg Dose"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#arm.description",
"valueString": "Administering 0.5mg of [Drug A]"
}
],
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#arm"
},
{
"id": "arm-dose2",
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#arm.name",
"valueString": "dose2"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#arm.description",
"valueString": "Administering 1.0mg of [Drug A]"
}
],
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#arm"
},
{
"id": "epoch-screening",
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#epoch.name",
"valueString": "Screening"
}
],
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#epoch"
},
{
"id": "epoch-single-blind-run-in",
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#epoch.name",
"valueString": "Single blind run-in"
}
],
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#epoch"
},
{
"id": "epoch-treatment-phase",
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#epoch.name",
"valueString": "Treatment"
}
],
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#epoch"
},
{
"id": "epoch-follow-up",
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#epoch.name",
"valueString": "Follow up"
}
],
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#epoch"
}
],
"status": "active",
"type": "study",
"purpose": "Defines the execution of study AD-4833PNFP-341",
"step": [
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm",
"valueUri": "#arm-dose1"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch",
"valueUri": "#epoch-screening"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 1
}
],
"name": "SCRN",
"description": "Screen",
"precondition": {
"description": "Informed Consent"
},
"exit": {
"description": "Screening assessments complete"
}
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm",
"valueUri": "#arm-dose1"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch",
"valueUri": "#epoch-single-blind-run-in"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 2
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armAssignment",
"valueString": "Randomized to Dose 1"
}
],
"name": "SBRI",
"description": "Single Blind Run-In",
"duration": {
"value": 1,
"system": "http://unitsofmeasure.org",
"code": "wk"
},
"precondition": {
"description": "Initial Single Blind Placebo dose"
},
"exit": {
"description": "1 week after start of Element"
}
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm",
"valueUri": "#arm-dose1"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch",
"valueUri": "#epoch-treatment-phase"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 3
}
],
"name": "DOSE 1",
"description": "Administer 0.5mg [Drug A] QD",
"duration": {
"value": 30,
"system": "http://unitsofmeasure.org",
"code": "wk"
},
"precondition": {
"description": "First dose of treatment where total drug dose of [Drug A] per day is 0.5 mg."
},
"exit": {
"description": "30 weeks after start of Element"
}
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm",
"valueUri": "#arm-dose1"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch",
"valueUri": "#epoch-follow-up"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 4
}
],
"name": "FLWUP",
"description": "Follow-Up",
"precondition": {
"description": "Last dose of treatment"
},
"exit": {
"description": "2 weeks after start of Element"
}
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm",
"valueUri": "#arm-dose2"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch",
"valueUri": "#epoch-screening"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 1
}
],
"name": "SCRN",
"description": "Screen",
"precondition": {
"description": "Informed Consent"
},
"exit": {
"description": "Screening assessments complete"
}
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm",
"valueUri": "#arm-dose2"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch",
"valueUri": "#epoch-single-blind-run-in"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 2
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armAssignment",
"valueString": "Randomized to 1.0 mg"
}
],
"name": "SBRI",
"description": "Single Blind Run-In",
"duration": {
"value": 1,
"system": "http://unitsofmeasure.org",
"code": "wk"
},
"precondition": {
"description": "First dose of Single Blind Placebo"
},
"exit": {
"description": "1 week after start of Element"
}
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm",
"valueUri": "#arm-dose2"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch",
"valueUri": "#epoch-treatment-phase"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 3
}
],
"name": "1.0 mg Dose",
"description": "Administer 1.0 mg [Drug A] QD",
"duration": {
"value": 30,
"system": "http://unitsofmeasure.org",
"code": "wk"
},
"precondition": {
"description": "Intial dose of treatment where total drug dose of [Drug A] per day is 1.0 mg."
},
"exit": {
"description": "30 weeks after start of Element"
}
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm",
"valueUri": "#arm-pio45mgs"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch",
"valueUri": "#epoch-follow-up"
},
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 4
}
],
"name": "FLWUP",
"description": "Follow-Up",
"precondition": {
"description": "Last dose of treatment"
},
"exit": {
"description": "2 weeks after start of Element"
}
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 1
}
],
"name": "VISIT 1",
"precondition": {
"description": "Screening"
},
"activity": [
{
"detail": {
"category": "encounter"
}
}
]
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 2
}
],
"name": "VISIT 2",
"precondition": {
"description": "single-blind placebo start"
},
"activity": [
{
"detail": {
"category": "encounter"
}
}
]
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 3
}
],
"name": "VISIT 3",
"precondition": {
"description": "Treatment start"
},
"activity": [
{
"detail": {
"category": "encounter"
}
}
]
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 4
}
],
"name": "VISIT 4",
"precondition": {
"description": "5 weeks after treatment start"
},
"activity": [
{
"detail": {
"category": "encounter"
}
}
]
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 5
}
],
"name": "VISIT 5",
"precondition": {
"description": "10 weeks after treatment start"
},
"activity": [
{
"detail": {
"category": "encounter"
}
}
]
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 6
}
],
"name": "VISIT 6",
"precondition": {
"description": "15 weeks after treatment start"
},
"activity": [
{
"detail": {
"category": "encounter"
}
}
]
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 7
}
],
"name": "VISIT 7",
"precondition": {
"description": "20 weeks after treatment start"
},
"activity": [
{
"detail": {
"category": "encounter"
}
}
]
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 8
}
],
"name": "VISIT 8",
"precondition": {
"description": "25 weeks after treatment start"
},
"activity": [
{
"detail": {
"category": "encounter"
}
}
]
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 9
}
],
"name": "VISIT 9",
"precondition": {
"description": "30 weeks after treatment start"
},
"activity": [
{
"detail": {
"category": "encounter"
}
}
]
},
{
"extension": [
{
"url": "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence",
"valueInteger": 10
}
],
"name": "VISIT 10",
"precondition": {
"description": "start of follow-up"
},
"activity": [
{
"detail": {
"category": "encounter"
}
}
]
}
]
}
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
© HL7.org 2011+. FHIR STU3 Candidate (v1.4.0-8139) generated on Thu, Mar 31, 2016 08:09+1100. QA Page
Links: Search |
Version History |
Table of Contents |
Compare to DSTU2 |
|
Propose a change