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
Protocol-study-profile-example.xml

Raw XML (canonical form)
Study protocol example (id = "study")
<Protocol xmlns="http://hl7.org/fhir">
  <id value="study"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p>
        <b>id: </b>study, </p>
      <p>
        <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#arm arm-dose1, </p>
      <p>
        <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#arm arm-dose2, </p>
      <p>
        <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#epoch epoch-screening, </p>
      <p>
        <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#epoch epoch-single-blind-run-in,
         </p>
      <p>
        <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#epoch epoch-treatment-phase,
         </p>
      <p>
        <b>extension: </b>http://example.org/example-do-not-use/Profilestudyprotocol#epoch epoch-follow-up, </p>
      <p>
        <b>status: </b>active, </p>
      <p>
        <b>type: </b>study, </p>
      <p>
        <b>purpose: </b>Defines the execution of study AD-4833PNFP-341, </p>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
      <p>
        <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>
    </div>
  </text>
  <extension id="arm-dose1" url="http://example.org/example-do-not-use/Profilestudyprotocol#arm">
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#arm.name">
      <valueString value="0.5 mg Dose"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#arm.description">
      <valueString value="Administering 0.5mg of [Drug A]"/>
    </extension>
  </extension>
  <extension id="arm-dose2" url="http://example.org/example-do-not-use/Profilestudyprotocol#arm">
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#arm.name">
      <valueString value="dose2"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#arm.description">
      <valueString value="Administering 1.0mg of [Drug A]"/>
    </extension>
  </extension>
  <extension id="epoch-screening" url="http://example.org/example-do-not-use/Profilestudyprotocol#epoch">
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#epoch.name">
      <valueString value="Screening"/>
    </extension>
  </extension>
  <extension id="epoch-single-blind-run-in" url="http://example.org/example-do-not-use/Profilestudyprotocol#epoch">
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#epoch.name">
      <valueString value="Single blind run-in"/>
    </extension>
  </extension>
  <extension id="epoch-treatment-phase" url="http://example.org/example-do-not-use/Profilestudyprotocol#epoch">
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#epoch.name">
      <valueString value="Treatment"/>
    </extension>
  </extension>
  <extension id="epoch-follow-up" url="http://example.org/example-do-not-use/Profilestudyprotocol#epoch">
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#epoch.name">
      <valueString value="Follow up"/>
    </extension>
  </extension>
  <status value="active"/>
  <type value="study"/>
  <purpose value="Defines the execution of study AD-4833PNFP-341"/>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.arm">
      <valueUri value="#arm-dose1"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch">
      <valueUri value="#epoch-screening"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="1"/>
    </extension>
    <name value="SCRN"/>
    <description value="Screen"/>
    <precondition>
      <description value="Informed Consent"/>
    </precondition>
    <exit>
      <description value="Screening assessments complete"/>
    </exit>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.arm">
      <valueUri value="#arm-dose1"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch">
      <valueUri value="#epoch-single-blind-run-in"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="2"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armAssignment">
      <valueString value="Randomized to Dose 1"/>
    </extension>
    <name value="SBRI"/>
    <description value="Single Blind Run-In"/>
    <duration>
      <value value="1"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="wk"/>
    </duration>
    <precondition>
      <description value="Initial Single Blind Placebo dose"/>
    </precondition>
    <exit>
      <description value="1 week after start of Element"/>
    </exit>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.arm">
      <valueUri value="#arm-dose1"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch">
      <valueUri value="#epoch-treatment-phase"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="3"/>
    </extension>
    <name value="DOSE 1"/>
    <description value="Administer 0.5mg [Drug A] QD"/>
    <duration>
      <value value="30"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="wk"/>
    </duration>
    <precondition>
      <description value="First dose of treatment where total drug dose of [Drug A] per day is 0.5 mg."/>
    </precondition>
    <exit>
      <description value="30 weeks after start of Element"/>
    </exit>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.arm">
      <valueUri value="#arm-dose1"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch">
      <valueUri value="#epoch-follow-up"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="4"/>
    </extension>
    <name value="FLWUP"/>
    <description value="Follow-Up"/>
    <precondition>
      <description value="Last dose of treatment"/>
    </precondition>
    <exit>
      <description value="2 weeks after start of Element"/>
    </exit>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.arm">
      <valueUri value="#arm-dose2"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch">
      <valueUri value="#epoch-screening"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="1"/>
    </extension>
    <name value="SCRN"/>
    <description value="Screen"/>
    <precondition>
      <description value="Informed Consent"/>
    </precondition>
    <exit>
      <description value="Screening assessments complete"/>
    </exit>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.arm">
      <valueUri value="#arm-dose2"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch">
      <valueUri value="#epoch-single-blind-run-in"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="2"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armAssignment">
      <valueString value="Randomized to 1.0 mg"/>
    </extension>
    <name value="SBRI"/>
    <description value="Single Blind Run-In"/>
    <duration>
      <value value="1"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="wk"/>
    </duration>
    <precondition>
      <description value="First dose of Single Blind Placebo"/>
    </precondition>
    <exit>
      <description value="1 week after start of Element"/>
    </exit>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.arm">
      <valueUri value="#arm-dose2"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch">
      <valueUri value="#epoch-treatment-phase"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="3"/>
    </extension>
    <name value="1.0 mg Dose"/>
    <description value="Administer 1.0 mg [Drug A] QD"/>
    <duration>
      <value value="30"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="wk"/>
    </duration>
    <precondition>
      <description value="Intial dose of treatment where total drug dose of [Drug A] per day is 1.0 mg."/>
    </precondition>
    <exit>
      <description value="30 weeks after start of Element"/>
    </exit>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.arm">
      <valueUri value="#arm-pio45mgs"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.epoch">
      <valueUri value="#epoch-follow-up"/>
    </extension>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="4"/>
    </extension>
    <name value="FLWUP"/>
    <description value="Follow-Up"/>
    <precondition>
      <description value="Last dose of treatment"/>
    </precondition>
    <exit>
      <description value="2 weeks after start of Element"/>
    </exit>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="1"/>
    </extension>
    <name value="VISIT 1"/>
    <precondition>
      <description value="Screening"/>
    </precondition>
    <activity>
      <detail>
        <category value="encounter"/>
      </detail>
    </activity>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="2"/>
    </extension>
    <name value="VISIT 2"/>
    <precondition>
      <description value="single-blind placebo start"/>
    </precondition>
    <activity>
      <detail>
        <category value="encounter"/>
      </detail>
    </activity>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="3"/>
    </extension>
    <name value="VISIT 3"/>
    <precondition>
      <description value="Treatment start"/>
    </precondition>
    <activity>
      <detail>
        <category value="encounter"/>
      </detail>
    </activity>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="4"/>
    </extension>
    <name value="VISIT 4"/>
    <precondition>
      <description value="5 weeks after treatment start"/>
    </precondition>
    <activity>
      <detail>
        <category value="encounter"/>
      </detail>
    </activity>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="5"/>
    </extension>
    <name value="VISIT 5"/>
    <precondition>
      <description value="10 weeks after treatment start"/>
    </precondition>
    <activity>
      <detail>
        <category value="encounter"/>
      </detail>
    </activity>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="6"/>
    </extension>
    <name value="VISIT 6"/>
    <precondition>
      <description value="15 weeks after treatment start"/>
    </precondition>
    <activity>
      <detail>
        <category value="encounter"/>
      </detail>
    </activity>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="7"/>
    </extension>
    <name value="VISIT 7"/>
    <precondition>
      <description value="20 weeks after treatment start"/>
    </precondition>
    <activity>
      <detail>
        <category value="encounter"/>
      </detail>
    </activity>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="8"/>
    </extension>
    <name value="VISIT 8"/>
    <precondition>
      <description value="25 weeks after treatment start"/>
    </precondition>
    <activity>
      <detail>
        <category value="encounter"/>
      </detail>
    </activity>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="9"/>
    </extension>
    <name value="VISIT 9"/>
    <precondition>
      <description value="30 weeks after treatment start"/>
    </precondition>
    <activity>
      <detail>
        <category value="encounter"/>
      </detail>
    </activity>
  </step>
  <step>
    <extension url="http://example.org/example-do-not-use/Profilestudyprotocol#step.armSequence">
      <valueInteger value="10"/>
    </extension>
    <name value="VISIT 10"/>
    <precondition>
      <description value="start of follow-up"/>
    </precondition>
    <activity>
      <detail>
        <category value="encounter"/>
      </detail>
    </activity>
  </step>
</Protocol>
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.