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="RECRUIT-QR"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2021-07-25T19:47:31.011+00:00"/>
<source value="#OQBs1nylhLsbUd39"/>
</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-recruitment-materials-questionnaire">http://hl7.org/fhir/us/sirb/Questionnaire/sirb-recruitment-materials-questionnaire</a></p><p><b>status</b>: completed</p><p><b>authored</b>: Jul 23, 2021 3:45:38 PM</p><blockquote><p><b>item</b></p><p><b>linkId</b>: rm1</p><p><b>text</b>: Research Study</p><blockquote><p><b>item</b></p><p><b>linkId</b>: rm1.1</p><p><b>text</b>: Study Title</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm1.2</p><p><b>text</b>: IRB Protocol Number</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm2</p><p><b>text</b>: Study Institution for which Recruitment Materials are being provided</p><blockquote><p><b>item</b></p><p><b>linkId</b>: rm2.1</p><p><b>text</b>: Institution Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm2.2</p><p><b>text</b>: City</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm2.3</p><p><b>text</b>: State</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm2.4</p><p><b>text</b>: Country</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm2.5</p><p><b>text</b>: Is this institution the sIRB (Reviewing Site) or a Relying Site?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm3</p><p><b>text</b>: Site Principal Investigator for the Site for which Recruitment Materials are being submitted</p><blockquote><p><b>item</b></p><p><b>linkId</b>: rm3.1</p><p><b>text</b>: First Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm3.3</p><p><b>text</b>: Last Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm3.2</p><p><b>text</b>: Suffix</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm3.4</p><p><b>text</b>: Degree(s)</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm4</p><p><b>text</b>: Recruitment Materials</p><blockquote><p><b>item</b></p><p><b>linkId</b>: rm4.1</p><p><b>text</b>: Will Recruitment Materials be Utilized?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm4.2</p><p><b>text</b>: Will Broadcast Materials be Utilized?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm4.3</p><p><b>text</b>: Broadcast Communication</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm4.4</p><p><b>text</b>: Will Printed Materials be Utilized?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm4.5</p><p><b>text</b>: Printed Communication</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm4.6</p><p><b>text</b>: Will Electronic Materials be Utilized?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm4.7</p><p><b>text</b>: Electronic Communication</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm4.8</p><p><b>text</b>: Will Direct Communication Materials be Utilized?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm6</p><p><b>text</b>: Distribution List and Audience Identification</p><blockquote><p><b>item</b></p><p><b>linkId</b>: rm6.1</p><p><b>text</b>: If recruitment material is being mailed, emailed, texted or otherwise distributed, describe where/how the distribution list will be obtained.</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm6.2</p><p><b>text</b>: Describe methods that will be used to identify audiences for advertising messages (eg. web advertising will be displayed on web sites popular with a particular demographic)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm6.3</p><p><b>text</b>: Any necessary permission will be obtained for posting/airing these (for example, permission to post a flyer on a bulletin board).</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm7</p><p><b>text</b>: Response to Recruitment Materials</p><blockquote><p><b>item</b></p><p><b>linkId</b>: rm7.1</p><p><b>text</b>: When potential participants respond to recruitment material, describe the information that will be provided to them about the study.</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm7.2</p><p><b>text</b>: Describe the plan to respond to potential participants who respond to recruitment materials. Include how many times you will attempt to respond to call the participant back, leave a voice message, send a reply email or conduct other follow-up communication.</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: rm7.3</p><p><b>text</b>: Types of communication methods that will be used to reply to potential participants who respond to recruitment materials</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-recruitment-materials-questionnaire"/>
<status value="completed"/>
<authored value="2021-07-23T15:45:38.473Z"/>
<item>
<linkId value="rm1"/>
<text value="Research Study"/>
<item>
<linkId value="rm1.1"/>
<text value="Study Title"/>
<answer>
<valueString value="Testing a new arthritis medication"/>
</answer>
</item>
<item>
<linkId value="rm1.2"/>
<text value="IRB Protocol Number"/>
<answer>
<valueString value="SUMC-1234567"/>
</answer>
</item>
</item>
<item>
<linkId value="rm2"/>
<text
value="Study Institution for which Recruitment Materials are being provided"/>
<item>
<linkId value="rm2.1"/>
<text value="Institution Name"/>
<answer>
<valueString value="Sample University Medical Center"/>
</answer>
</item>
<item>
<linkId value="rm2.2"/>
<text value="City"/>
<answer>
<valueString value="Sample City"/>
</answer>
</item>
<item>
<linkId value="rm2.3"/>
<text value="State"/>
<answer>
<valueString value="NC"/>
</answer>
</item>
<item>
<linkId value="rm2.4"/>
<text value="Country"/>
<answer>
<valueString value="United States"/>
</answer>
</item>
<item>
<linkId value="rm2.5"/>
<text
value="Is this institution the sIRB (Reviewing Site) or a Relying Site?"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="sIRB"/>
<display value="sIRB (Reviewing Site)"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="rm3"/>
<text
value="Site Principal Investigator for the Site for which Recruitment Materials are being submitted"/>
<item>
<linkId value="rm3.1"/>
<text value="First Name"/>
<answer>
<valueString value="John"/>
</answer>
</item>
<item>
<linkId value="rm3.3"/>
<text value="Last Name"/>
<answer>
<valueString value="Doe"/>
</answer>
</item>
<item>
<linkId value="rm3.2"/>
<text value="Suffix"/>
<answer>
<valueString value="IV"/>
</answer>
</item>
<item>
<linkId value="rm3.4"/>
<text value="Degree(s)"/>
<answer>
<valueString value="567-123-1234"/>
</answer>
</item>
</item>
<item>
<linkId value="rm4"/>
<text value="Recruitment Materials"/>
<item>
<linkId value="rm4.1"/>
<text value="Will Recruitment Materials be Utilized?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="rm4.2"/>
<text value="Will Broadcast Materials be Utilized?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="rm4.3"/>
<text value="Broadcast Communication"/>
<item>
<linkId value="rm4.3.1"/>
<text value="Audio"/>
</item>
<item>
<linkId value="rm4.3.3"/>
<text value="Video"/>
</item>
<item>
<linkId value="rm4.3.7"/>
<text value="TV Spot"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="rm4.3.8"/>
<text value="TV Spot Description"/>
<answer>
<valueString
value="30 second TV ad airing once daily for 4 weeks during nightly news on TV news show with most viewers this year"/>
</answer>
</item>
</item>
<item>
<linkId value="rm4.4"/>
<text value="Will Printed Materials be Utilized?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="rm4.5"/>
<text value="Printed Communication"/>
<item>
<linkId value="rm4.5.1"/>
<text value="Billboard/Bus Ad"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="rm4.5.2"/>
<text value="Billboard/Bus Ad Description"/>
<answer>
<valueString
value="Billboard for 6 months on 3 interstate highways in NC once study opens for enrollment"/>
</answer>
</item>
<item>
<linkId value="rm4.5.13"/>
<text value="Postcard"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="rm4.5.14"/>
<text value="Postcard Description"/>
<answer>
<valueString
value="Postcard mailed to all patients in the Sample University Medical Center eHealth Portal with arthritis diagnosis codes during the month that the study opens for recruitment"/>
</answer>
</item>
</item>
<item>
<linkId value="rm4.6"/>
<text value="Will Electronic Materials be Utilized?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="rm4.7"/>
<text value="Electronic Communication"/>
<item>
<linkId value="rm4.7.11"/>
<text value="Web Page Advertising"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="rm4.7.12"/>
<text value="Web Page Ad Description"/>
<answer>
<valueString
value="Ads triggered by searches for "arthritis" running for 6 months"/>
</answer>
</item>
<item>
<linkId value="rm4.7.19"/>
<text value="eHealth Portal"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="rm4.7.20"/>
<text value="eHealthPortal Description"/>
<answer>
<valueString
value="eHealth Portal message to all patients in the Sample University Medical Center eHealth Portal with arthritis diagnosis codes"/>
</answer>
</item>
</item>
<item>
<linkId value="rm4.8"/>
<text value="Will Direct Communication Materials be Utilized?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="rm6"/>
<text value="Distribution List and Audience Identification"/>
<item>
<linkId value="rm6.1"/>
<text
value="If recruitment material is being mailed, emailed, texted or otherwise distributed, describe where/how the distribution list will be obtained."/>
<answer>
<valueString
value="all patients in the Sample University Medical Center eHealth Portal with arthritis diagnosis codes"/>
</answer>
</item>
<item>
<linkId value="rm6.2"/>
<text
value="Describe methods that will be used to identify audiences for advertising messages (eg. web advertising will be displayed on web sites popular with a particular demographic)"/>
<answer>
<valueString
value="TV broadcast ads are targeted at community news viewers as a whole. Web advertising is shown to search engine users who query for the keyword "arthritis""/>
</answer>
</item>
<item>
<linkId value="rm6.3"/>
<text
value="Any necessary permission will be obtained for posting/airing these (for example, permission to post a flyer on a bulletin board)."/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="rm7"/>
<text value="Response to Recruitment Materials"/>
<item>
<linkId value="rm7.1"/>
<text
value="When potential participants respond to recruitment material, describe the information that will be provided to them about the study."/>
<answer>
<valueString
value="Inclusion and exclusion criteria, study length, study goals, explanation of a double-blind study and enrollment process"/>
</answer>
</item>
<item>
<linkId value="rm7.2"/>
<text
value="Describe the plan to respond to potential participants who respond to recruitment materials. Include how many times you will attempt to respond to call the participant back, leave a voice message, send a reply email or conduct other follow-up communication."/>
<answer>
<valueString
value="If potential participant responds via email, then replies will be via email. If potential participant calls, then replies will be phone calls or voice messages. If potential participant responds via eHealth Portal, then replies will be via the eHealth Portal. If participants don't response, then one followup communication in the same media as the first will be one."/>
</answer>
</item>
<item>
<linkId value="rm7.3"/>
<text
value="Types of communication methods that will be used to reply to potential participants who respond to recruitment materials"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="VM"/>
<display value="Telephone and voice messages"/>
</valueCoding>
</answer>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="EHPRTL"/>
<display value="eHealth Portal messaging"/>
</valueCoding>
</answer>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="EMAIL"/>
<display value="Email"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="ADMIN00"/>
<text value="Administrative Use Only"/>
<item>
<linkId value="ADMIN01"/>
<text value="Link ID prefix"/>
<answer>
<valueString value="rm"/>
</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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