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
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xs: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
<http://hl7.org/fhir//Protocol/study> a fhir:Protocol;
fhir:nodeRole fhir:treeRoot;
fhir:Resource.id [ fhir:value "study"];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ]
];
fhir:DomainResource.extension [
fhir:index 0;
fhir:Element.id [ fhir:value "arm-dose1" ];
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#arm.name" ];
fhir:Extension.valueString [ fhir:value "0.5 mg Dose" ] ];
fhir:Element.extension [
fhir:index 1;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#arm.description" ];
fhir:Extension.valueString [ fhir:value "Administering 0.5mg of [Drug A]" ] ];
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#arm" ]
];
fhir:DomainResource.extension [
fhir:index 1;
fhir:Element.id [ fhir:value "arm-dose2" ];
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#arm.name" ];
fhir:Extension.valueString [ fhir:value "dose2" ] ];
fhir:Element.extension [
fhir:index 1;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#arm.description" ];
fhir:Extension.valueString [ fhir:value "Administering 1.0mg of [Drug A]" ] ];
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#arm" ]
];
fhir:DomainResource.extension [
fhir:index 2;
fhir:Element.id [ fhir:value "epoch-screening" ];
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#epoch.name" ];
fhir:Extension.valueString [ fhir:value "Screening" ] ];
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#epoch" ]
];
fhir:DomainResource.extension [
fhir:index 3;
fhir:Element.id [ fhir:value "epoch-single-blind-run-in" ];
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#epoch.name" ];
fhir:Extension.valueString [ fhir:value "Single blind run-in" ] ];
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#epoch" ]
];
fhir:DomainResource.extension [
fhir:index 4;
fhir:Element.id [ fhir:value "epoch-treatment-phase" ];
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#epoch.name" ];
fhir:Extension.valueString [ fhir:value "Treatment" ] ];
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#epoch" ]
];
fhir:DomainResource.extension [
fhir:index 5;
fhir:Element.id [ fhir:value "epoch-follow-up" ];
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#epoch.name" ];
fhir:Extension.valueString [ fhir:value "Follow up" ] ];
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#epoch" ]
];
fhir:Protocol.status [ fhir:value "active"];
fhir:Protocol.type [ fhir:value "study"];
fhir:Protocol.purpose [ fhir:value "Defines the execution of study AD-4833PNFP-341"];
fhir:Protocol.step [
fhir:index 0;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm" ];
fhir:Extension.valueUri [ fhir:value "#arm-dose1" ] ];
fhir:Element.extension [
fhir:index 1;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch" ];
fhir:Extension.valueUri [ fhir:value "#epoch-screening" ] ];
fhir:Element.extension [
fhir:index 2;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "1"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "SCRN" ];
fhir:Protocol.step.description [ fhir:value "Screen" ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "Informed Consent" ] ];
fhir:Protocol.step.exit [
fhir:Protocol.step.precondition.description [ fhir:value "Screening assessments complete" ] ]
];
fhir:Protocol.step [
fhir:index 1;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm" ];
fhir:Extension.valueUri [ fhir:value "#arm-dose1" ] ];
fhir:Element.extension [
fhir:index 1;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch" ];
fhir:Extension.valueUri [ fhir:value "#epoch-single-blind-run-in" ] ];
fhir:Element.extension [
fhir:index 2;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "2"^^xs:int ] ];
fhir:Element.extension [
fhir:index 3;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armAssignment" ];
fhir:Extension.valueString [ fhir:value "Randomized to Dose 1" ] ];
fhir:Protocol.step.name [ fhir:value "SBRI" ];
fhir:Protocol.step.description [ fhir:value "Single Blind Run-In" ];
fhir:Protocol.step.duration [
fhir:Quantity.value [ fhir:value "1"^^xs:decimal ];
fhir:Quantity.system [ fhir:value "http://unitsofmeasure.org" ];
fhir:Quantity.code [ fhir:value "wk" ] ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "Initial Single Blind Placebo dose" ] ];
fhir:Protocol.step.exit [
fhir:Protocol.step.precondition.description [ fhir:value "1 week after start of Element" ] ]
];
fhir:Protocol.step [
fhir:index 2;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm" ];
fhir:Extension.valueUri [ fhir:value "#arm-dose1" ] ];
fhir:Element.extension [
fhir:index 1;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch" ];
fhir:Extension.valueUri [ fhir:value "#epoch-treatment-phase" ] ];
fhir:Element.extension [
fhir:index 2;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "3"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "DOSE 1" ];
fhir:Protocol.step.description [ fhir:value "Administer 0.5mg [Drug A] QD" ];
fhir:Protocol.step.duration [
fhir:Quantity.value [ fhir:value "30"^^xs:decimal ];
fhir:Quantity.system [ fhir:value "http://unitsofmeasure.org" ];
fhir:Quantity.code [ fhir:value "wk" ] ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "First dose of treatment where total drug dose of [Drug A] per day is 0.5 mg." ] ];
fhir:Protocol.step.exit [
fhir:Protocol.step.precondition.description [ fhir:value "30 weeks after start of Element" ] ]
];
fhir:Protocol.step [
fhir:index 3;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm" ];
fhir:Extension.valueUri [ fhir:value "#arm-dose1" ] ];
fhir:Element.extension [
fhir:index 1;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch" ];
fhir:Extension.valueUri [ fhir:value "#epoch-follow-up" ] ];
fhir:Element.extension [
fhir:index 2;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "4"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "FLWUP" ];
fhir:Protocol.step.description [ fhir:value "Follow-Up" ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "Last dose of treatment" ] ];
fhir:Protocol.step.exit [
fhir:Protocol.step.precondition.description [ fhir:value "2 weeks after start of Element" ] ]
];
fhir:Protocol.step [
fhir:index 4;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm" ];
fhir:Extension.valueUri [ fhir:value "#arm-dose2" ] ];
fhir:Element.extension [
fhir:index 1;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch" ];
fhir:Extension.valueUri [ fhir:value "#epoch-screening" ] ];
fhir:Element.extension [
fhir:index 2;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "1"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "SCRN" ];
fhir:Protocol.step.description [ fhir:value "Screen" ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "Informed Consent" ] ];
fhir:Protocol.step.exit [
fhir:Protocol.step.precondition.description [ fhir:value "Screening assessments complete" ] ]
];
fhir:Protocol.step [
fhir:index 5;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm" ];
fhir:Extension.valueUri [ fhir:value "#arm-dose2" ] ];
fhir:Element.extension [
fhir:index 1;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch" ];
fhir:Extension.valueUri [ fhir:value "#epoch-single-blind-run-in" ] ];
fhir:Element.extension [
fhir:index 2;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "2"^^xs:int ] ];
fhir:Element.extension [
fhir:index 3;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armAssignment" ];
fhir:Extension.valueString [ fhir:value "Randomized to 1.0 mg" ] ];
fhir:Protocol.step.name [ fhir:value "SBRI" ];
fhir:Protocol.step.description [ fhir:value "Single Blind Run-In" ];
fhir:Protocol.step.duration [
fhir:Quantity.value [ fhir:value "1"^^xs:decimal ];
fhir:Quantity.system [ fhir:value "http://unitsofmeasure.org" ];
fhir:Quantity.code [ fhir:value "wk" ] ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "First dose of Single Blind Placebo" ] ];
fhir:Protocol.step.exit [
fhir:Protocol.step.precondition.description [ fhir:value "1 week after start of Element" ] ]
];
fhir:Protocol.step [
fhir:index 6;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm" ];
fhir:Extension.valueUri [ fhir:value "#arm-dose2" ] ];
fhir:Element.extension [
fhir:index 1;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch" ];
fhir:Extension.valueUri [ fhir:value "#epoch-treatment-phase" ] ];
fhir:Element.extension [
fhir:index 2;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "3"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "1.0 mg Dose" ];
fhir:Protocol.step.description [ fhir:value "Administer 1.0 mg [Drug A] QD" ];
fhir:Protocol.step.duration [
fhir:Quantity.value [ fhir:value "30"^^xs:decimal ];
fhir:Quantity.system [ fhir:value "http://unitsofmeasure.org" ];
fhir:Quantity.code [ fhir:value "wk" ] ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "Intial dose of treatment where total drug dose of [Drug A] per day is 1.0 mg." ] ];
fhir:Protocol.step.exit [
fhir:Protocol.step.precondition.description [ fhir:value "30 weeks after start of Element" ] ]
];
fhir:Protocol.step [
fhir:index 7;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.arm" ];
fhir:Extension.valueUri [ fhir:value "#arm-pio45mgs" ] ];
fhir:Element.extension [
fhir:index 1;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch" ];
fhir:Extension.valueUri [ fhir:value "#epoch-follow-up" ] ];
fhir:Element.extension [
fhir:index 2;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "4"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "FLWUP" ];
fhir:Protocol.step.description [ fhir:value "Follow-Up" ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "Last dose of treatment" ] ];
fhir:Protocol.step.exit [
fhir:Protocol.step.precondition.description [ fhir:value "2 weeks after start of Element" ] ]
];
fhir:Protocol.step [
fhir:index 8;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "1"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "VISIT 1" ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "Screening" ] ];
fhir:Protocol.step.activity [
fhir:index 0;
fhir:Protocol.step.activity.detail [
fhir:Protocol.step.activity.detail.category [ fhir:value "encounter" ] ] ]
];
fhir:Protocol.step [
fhir:index 9;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "2"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "VISIT 2" ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "single-blind placebo start" ] ];
fhir:Protocol.step.activity [
fhir:index 0;
fhir:Protocol.step.activity.detail [
fhir:Protocol.step.activity.detail.category [ fhir:value "encounter" ] ] ]
];
fhir:Protocol.step [
fhir:index 10;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "3"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "VISIT 3" ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "Treatment start" ] ];
fhir:Protocol.step.activity [
fhir:index 0;
fhir:Protocol.step.activity.detail [
fhir:Protocol.step.activity.detail.category [ fhir:value "encounter" ] ] ]
];
fhir:Protocol.step [
fhir:index 11;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "4"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "VISIT 4" ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "5 weeks after treatment start" ] ];
fhir:Protocol.step.activity [
fhir:index 0;
fhir:Protocol.step.activity.detail [
fhir:Protocol.step.activity.detail.category [ fhir:value "encounter" ] ] ]
];
fhir:Protocol.step [
fhir:index 12;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "5"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "VISIT 5" ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "10 weeks after treatment start" ] ];
fhir:Protocol.step.activity [
fhir:index 0;
fhir:Protocol.step.activity.detail [
fhir:Protocol.step.activity.detail.category [ fhir:value "encounter" ] ] ]
];
fhir:Protocol.step [
fhir:index 13;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "6"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "VISIT 6" ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "15 weeks after treatment start" ] ];
fhir:Protocol.step.activity [
fhir:index 0;
fhir:Protocol.step.activity.detail [
fhir:Protocol.step.activity.detail.category [ fhir:value "encounter" ] ] ]
];
fhir:Protocol.step [
fhir:index 14;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "7"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "VISIT 7" ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "20 weeks after treatment start" ] ];
fhir:Protocol.step.activity [
fhir:index 0;
fhir:Protocol.step.activity.detail [
fhir:Protocol.step.activity.detail.category [ fhir:value "encounter" ] ] ]
];
fhir:Protocol.step [
fhir:index 15;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "8"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "VISIT 8" ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "25 weeks after treatment start" ] ];
fhir:Protocol.step.activity [
fhir:index 0;
fhir:Protocol.step.activity.detail [
fhir:Protocol.step.activity.detail.category [ fhir:value "encounter" ] ] ]
];
fhir:Protocol.step [
fhir:index 16;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "9"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "VISIT 9" ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "30 weeks after treatment start" ] ];
fhir:Protocol.step.activity [
fhir:index 0;
fhir:Protocol.step.activity.detail [
fhir:Protocol.step.activity.detail.category [ fhir:value "encounter" ] ] ]
];
fhir:Protocol.step [
fhir:index 17;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence" ];
fhir:Extension.valueInteger [ fhir:value "10"^^xs:int ] ];
fhir:Protocol.step.name [ fhir:value "VISIT 10" ];
fhir:Protocol.step.precondition [
fhir:Protocol.step.precondition.description [ fhir:value "start of follow-up" ] ];
fhir:Protocol.step.activity [
fhir:index 0;
fhir:Protocol.step.activity.detail [
fhir:Protocol.step.activity.detail.category [ fhir:value "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