Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot
Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot
This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions 
<QuestionnaireResponse xmlns="http://hl7.org/fhir">
<id value="MEDICAL-AE-QR"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2021-07-23T21:09:31.112+00:00"/>
<source value="#pgbjyveyUglHxqGY"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><p><b>questionnaire</b>: <a href="http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire">http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire</a></p><p><b>status</b>: completed</p><p><b>authored</b>: Jul 23, 2021 4:36:24 PM</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae1</p><p><b>text</b>: RESEARCH STUDY</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae1.1</p><p><b>text</b>: Study Title</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae1.2</p><p><b>text</b>: IRB Protocol Number</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae1.3</p><p><b>text</b>: Study Type</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae1.4</p><p><b>text</b>: Does this protocol require an FDA exemption?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae1.5</p><p><b>text</b>: Is an IND or IDE being used in this study?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae2</p><p><b>text</b>: Site Principal Investigator</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae2.1</p><p><b>text</b>: First Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae2.2</p><p><b>text</b>: Last Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae2.6</p><p><b>text</b>: Degree(s)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae2.3</p><p><b>text</b>: Phone</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae2.4</p><p><b>text</b>: Email</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae3</p><p><b>text</b>: Primary Contact</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae3.1</p><p><b>text</b>: First Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae3.2</p><p><b>text</b>: Last Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae3.3</p><p><b>text</b>: Phone</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae3.4</p><p><b>text</b>: Email</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae4</p><p><b>text</b>: Site/Organization</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae4.1</p><p><b>text</b>: Name of organization/site where the event occurred</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae4.2</p><p><b>text</b>: Name of organization/site which is recording the Adverse Medical event</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5</p><p><b>text</b>: Participant Information</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.1</p><p><b>text</b>: Patient ID</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.2</p><p><b>text</b>: Age</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.3</p><p><b>text</b>: Birth Sex</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.4</p><p><b>text</b>: Weight</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.5</p><p><b>text</b>: Height</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.6</p><p><b>text</b>: Ethnicity</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.7</p><p><b>text</b>: Race</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.8</p><p><b>text</b>: Which Arm/Cohort/treatment group was the participant assigned to (if known)?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.9</p><p><b>text</b>: Participant dosed or received study agent</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.11</p><p><b>text</b>: Were there any Protocol Deviations/Violations/Exceptions for this participant?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6</p><p><b>text</b>: Adverse Medical Event Information</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.1</p><p><b>text</b>: Submission Type</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.2</p><p><b>text</b>: Start Date</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.3</p><p><b>text</b>: Reported Date</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.4</p><p><b>text</b>: Recorded Date</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.5a</p><p><b>text</b>: Narrative of the Adverse Event:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.5b</p><p><b>text</b>: Medical Description of Adverse Event</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.6</p><p><b>text</b>: Is the Adverse Medical event still ongoing?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.7</p><p><b>text</b>: Stop Date</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.8</p><p><b>text</b>: Was the event expected?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.9</p><p><b>text</b>: Severity</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.10</p><p><b>text</b>: Is the Adverse Medical Event Serious?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.11</p><p><b>text</b>: Seriousness</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.12</p><p><b>text</b>: What is the date Adverse Medical Event became serious?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.13</p><p><b>text</b>: Outcome of Adverse Medical Event</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.15</p><p><b>text</b>: Relationship of Adverse Medical Event to Study Intervention</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.16</p><p><b>text</b>: Rationale for relationship with study intervention</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.23</p><p><b>text</b>: Action Taken Regarding Study Intervention</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.24</p><p><b>text</b>: If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did AE diminish/abate?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.25</p><p><b>text</b>: If study intervention was restarted (rechallenge) did AE recur?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.26</p><p><b>text</b>: Did the participant receive any relevant concomitant medications in response to the SAE?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.27</p><p><b>text</b>: SAE Concomitant Medications</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.29</p><p><b>text</b>: Did the participant receive any treatments/procedures in response to the SAE?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae7</p><p><b>text</b>: Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?</p><h3>Answers</h3><table class="grid"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td><span title="{http://terminology.hl7.org/CodeSystem/v2-0532 Y}">Yes</span></td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae8</p><p><b>text</b>: SAE Laboratory or Diagnostic Tests</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae8.1</p><p><b>text</b>: Lab/Diagnostic Test</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae8.2</p><p><b>text</b>: Date</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae8.3</p><p><b>text</b>: Result</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae8.4</p><p><b>text</b>: Low Range</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae8.5</p><p><b>text</b>: High Range</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae8.6</p><p><b>text</b>: Comments</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN00</p><p><b>text</b>: Administrative Use Only</p><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN01</p><p><b>text</b>: Link ID prefix</p></blockquote></blockquote></div>
</text>
<questionnaire
value="http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire"/>
<status value="completed"/>
<authored value="2021-07-23T16:36:24.459Z"/>
<item>
<linkId value="mae1"/>
<text value="RESEARCH STUDY"/>
<item>
<linkId value="mae1.1"/>
<text value="Study Title"/>
<answer>
<valueString value="A study comparison of Treatment A and B"/>
</answer>
</item>
<item>
<linkId value="mae1.2"/>
<text value="IRB Protocol Number"/>
<answer>
<valueString value="PRO098765"/>
</answer>
</item>
<item>
<linkId value="mae1.3"/>
<text value="Study Type"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="INT"/>
<display value="Interventional"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae1.4"/>
<text value="Does this protocol require an FDA exemption?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae1.5"/>
<text value="Is an IND or IDE being used in this study?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="mae2"/>
<text value="Site Principal Investigator"/>
<item>
<linkId value="mae2.1"/>
<text value="First Name"/>
<answer>
<valueString value="Mike"/>
</answer>
</item>
<item>
<linkId value="mae2.2"/>
<text value="Last Name"/>
<answer>
<valueString value="Medical"/>
</answer>
</item>
<item>
<linkId value="mae2.6"/>
<text value="Degree(s)"/>
<answer>
<valueString value="MD"/>
</answer>
</item>
<item>
<linkId value="mae2.3"/>
<text value="Phone"/>
<answer>
<valueString value="111-555-1213"/>
</answer>
</item>
<item>
<linkId value="mae2.4"/>
<text value="Email"/>
<answer>
<valueString value="mike.medical.email2.citymedical.edu"/>
</answer>
</item>
</item>
<item>
<linkId value="mae3"/>
<text value="Primary Contact"/>
<item>
<linkId value="mae3.1"/>
<text value="First Name"/>
<answer>
<valueString value="Ben"/>
</answer>
</item>
<item>
<linkId value="mae3.2"/>
<text value="Last Name"/>
<answer>
<valueString value="Coordinator"/>
</answer>
</item>
<item>
<linkId value="mae3.3"/>
<text value="Phone"/>
<answer>
<valueString value="111-555-1212"/>
</answer>
</item>
<item>
<linkId value="mae3.4"/>
<text value="Email"/>
<answer>
<valueString value="ben.coordinator@centralsamplehosp.org"/>
</answer>
</item>
</item>
<item>
<linkId value="mae4"/>
<text value="Site/Organization"/>
<item>
<linkId value="mae4.1"/>
<text value="Name of organization/site where the event occurred"/>
<answer>
<valueString value="Central Sample Hospital"/>
</answer>
</item>
<item>
<linkId value="mae4.2"/>
<text
value="Name of organization/site which is recording the Adverse Medical event"/>
<answer>
<valueString value="City Medical University"/>
</answer>
</item>
</item>
<item>
<linkId value="mae5"/>
<text value="Participant Information"/>
<item>
<linkId value="mae5.1"/>
<text value="Patient ID"/>
<answer>
<valueString value="12345"/>
</answer>
</item>
<item>
<linkId value="mae5.2"/>
<text value="Age"/>
<answer>
<valueString value="58"/>
</answer>
</item>
<item>
<linkId value="mae5.3"/>
<text value="Birth Sex"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0001"/>
<code value="M"/>
<display value="Male"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae5.4"/>
<text value="Weight"/>
<answer>
<valueQuantity>
<value value="245"/>
<unit value="[lb]"/>
</valueQuantity>
</answer>
</item>
<item>
<linkId value="mae5.5"/>
<text value="Height"/>
<answer>
<valueQuantity>
<value value="67"/>
<unit value="[in]"/>
</valueQuantity>
</answer>
</item>
<item>
<linkId value="mae5.6"/>
<text value="Ethnicity"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v3-Ethnicity"/>
<code value="2186-5"/>
<display value="Not Hispanic or Latino"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae5.7"/>
<text value="Race"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v3-Race"/>
<code value="2106-3"/>
<display value="White"/>
</valueCoding>
</answer>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v3-Race"/>
<code value="2054-5"/>
<display value="Black or African American"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae5.8"/>
<text
value="Which Arm/Cohort/treatment group was the participant assigned to (if known)?"/>
<answer>
<valueString value="unknown"/>
</answer>
</item>
<item>
<linkId value="mae5.9"/>
<text value="Participant dosed or received study agent"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="NI"/>
<display value="No Information"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae5.11"/>
<text
value="Were there any Protocol Deviations/Violations/Exceptions for this participant?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="mae6"/>
<text value="Adverse Medical Event Information"/>
<item>
<linkId value="mae6.1"/>
<text value="Submission Type"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="INITIAL"/>
<display value="Initial"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae6.2"/>
<text value="Start Date"/>
<answer>
<valueDate value="2021-01-05"/>
</answer>
</item>
<item>
<linkId value="mae6.3"/>
<text value="Reported Date"/>
<answer>
<valueDate value="2021-11-06"/>
</answer>
</item>
<item>
<linkId value="mae6.4"/>
<text value="Recorded Date"/>
<answer>
<valueDate value="2021-11-06"/>
</answer>
</item>
<item>
<linkId value="mae6.5a"/>
<text value="Narrative of the Adverse Event:"/>
<answer>
<valueString
value="Blood clot developed in right leg after several days of inactivity. Participant experienced swelling and pain."/>
</answer>
</item>
<item>
<linkId value="mae6.5b"/>
<text value="Medical Description of Adverse Event"/>
<answer>
<valueString value="Deep Vein Thrombosis"/>
</answer>
</item>
<item>
<linkId value="mae6.6"/>
<text value="Is the Adverse Medical event still ongoing?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae6.7"/>
<text value="Stop Date"/>
<answer>
<valueDate value="2021-01-05"/>
</answer>
</item>
<item>
<linkId value="mae6.8"/>
<text value="Was the event expected?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0239"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae6.9"/>
<text value="Severity"/>
<answer>
<valueCoding>
<system
value="http://terminology.hl7.org/CodeSystem/adverse-event-severity"/>
<code value="mild"/>
<display value="Mild"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae6.10"/>
<text value="Is the Adverse Medical Event Serious?"/>
<answer>
<valueCoding>
<system
value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
<code value="serious"/>
<display value="Serious"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae6.11"/>
<text value="Seriousness"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0240"/>
<code value="H"/>
<display value="Caused hospitalized"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae6.12"/>
<text value="What is the date Adverse Medical Event became serious?"/>
<answer>
<valueDate value="2021-01-05"/>
</answer>
</item>
<item>
<linkId value="mae6.13"/>
<text value="Outcome of Adverse Medical Event"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0241"/>
<code value="F"/>
<display value="Fully recovered"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae6.15"/>
<text value="Relationship of Adverse Medical Event to Study Intervention"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0250"/>
<code value="S"/>
<display value="Somewhat probable"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae6.16"/>
<text value="Rationale for relationship with study intervention"/>
<answer>
<valueString
value="Neither treatment A nor treatment B have known increased risks of blood clots. Patient was inactive for several days which might have been the cause."/>
</answer>
</item>
<item>
<linkId value="mae6.23"/>
<text value="Action Taken Regarding Study Intervention"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0251"/>
<code value="WT"/>
<display value="Product withdrawn temporarily"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae6.24"/>
<text
value="If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did AE diminish/abate?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae6.25"/>
<text
value="If study intervention was restarted (rechallenge) did AE recur?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae6.26"/>
<text
value="Did the participant receive any relevant concomitant medications in response to the SAE?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae6.27"/>
<text value="SAE Concomitant Medications"/>
<item>
<linkId value="mae6.28.1"/>
<text value="Medication Name"/>
<answer>
<valueString value="warfarin"/>
</answer>
</item>
<item>
<linkId value="mae6.28.2"/>
<text value="Indication"/>
<answer>
<valueString value="anticoagulant"/>
</answer>
</item>
<item>
<linkId value="mae6.28.3"/>
<text value="Start Date"/>
<answer>
<valueDate value="2021-01-05"/>
</answer>
</item>
<item>
<linkId value="mae6.28.4"/>
<text value="Stop Date"/>
<answer>
<valueDate value="2021-04-04"/>
</answer>
</item>
<item>
<linkId value="mae6.28.5"/>
<text value="Ongoing"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="mae6.29"/>
<text
value="Did the participant receive any treatments/procedures in response to the SAE?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="mae7"/>
<text
value="Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="mae8"/>
<text value="SAE Laboratory or Diagnostic Tests"/>
<item>
<linkId value="mae8.1"/>
<text value="Lab/Diagnostic Test"/>
<answer>
<valueString value="ultrasound"/>
</answer>
</item>
<item>
<linkId value="mae8.2"/>
<text value="Date"/>
<answer>
<valueDate value="2021-01-05"/>
</answer>
</item>
<item>
<linkId value="mae8.3"/>
<text value="Result"/>
<answer>
<valueString value="positive"/>
</answer>
</item>
<item>
<linkId value="mae8.4"/>
<text value="Low Range"/>
<answer>
<valueString value="-"/>
</answer>
</item>
<item>
<linkId value="mae8.5"/>
<text value="High Range"/>
<answer>
<valueString value="-"/>
</answer>
</item>
<item>
<linkId value="mae8.6"/>
<text value="Comments"/>
<answer>
<valueString value="blood clot noted"/>
</answer>
</item>
</item>
<item>
<linkId value="ADMIN00"/>
<text value="Administrative Use Only"/>
<item>
<linkId value="ADMIN01"/>
<text value="Link ID prefix"/>
<answer>
<valueString value="mae"/>
</answer>
</item>
</item>
</QuestionnaireResponse>
IG © 2020+ HL7 International - BR&R Work Group. Package hl7.fhir.us.sirb#0.1.0 based on FHIR 4.0.1. Generated 2021-08-10
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