Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use United States of America flag

Single Institutional Review Board (sIRB) Implementation Guide, published by HL7 International - BR&R Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/fhir-sirb/ and changes regularly. See the Directory of published versions

Example QuestionnaireResponse: Example Recruitment Materials Questionnaire Response

LinkIdTextDefinitionAnswerdoco
.. recruitment-populate-exampleQRQuestionnaireResponse
... rm1Research Study
.... rm1.1Study TitleStudy of Drug A for arthritis
.... rm1.2IRB Protocol NumberPRO098765
... rm9Submission Type and Relying Site Selection (if applicable)
.... rm9.1Is this Recruitment Materials Form being submitted to request approval for the recruitment materials for the overall study?expandedYes-NoIndicator N: No
.... ExternalDataFor_rm9.2External Data For linkId rm9.2
.... rm9.2If this form and the associated recruitment materials are specific to a relying site, select the relying site in order to pre-populate the relying institution and relying site principal investigator details below.[not stated] : Central Campus Test University | | Maria Smith, PhD | Central, MI
... rm2Study Institution for which Recruitment Materials are being provided
.... rm2.1Institution NameCentral Campus Test University
.... rm2.2CityCentral
.... rm2.3StateMI
.... rm2.4CountryUnited States
... rm3Site Principal Investigator for the Site for which Recruitment Materials are being submitted
.... rm3.1First NameMaria
.... rm3.3Last NameSmith
.... rm3.4Degree(s)PhD
... rm4Recruitment Materials
.... rm4.1Will Recruitment Materials be Utilized?expandedYes-NoIndicator Y: Yes
.... rm4.2Will Broadcast Materials be Utilized?expandedYes-NoIndicator Y: Yes
.... rm4.3Broadcast Communication
..... rm4.3.7TV Spottrue
..... rm4.3.8TV Spot Description30 second TV ad airing once daily for 4 weeks during nightly news on TV news show with most viewers this year
.... rm4.4Will Printed Materials be Utilized?expandedYes-NoIndicator Y: Yes
.... rm4.5Printed Communication
..... rm4.5.1Billboard/Bus Adtrue
..... rm4.5.2Billboard/Bus Ad DescriptionBillboard for 6 months on 3 interstate highway locations in MI once study opens for enrollment
..... rm4.5.13Postcardtrue
..... rm4.5.14Postcard DescriptionPostcard mailed to all patients in the Central Campus Test University eHealth Portal with arthritis diagnosis codes during the month that the study opens for recruitment
.... rm4.6Will Electronic Materials be Utilized?expandedYes-NoIndicator Y: Yes
.... rm4.7Electronic Communication
..... rm4.7.11Web Page Advertisingtrue
..... rm4.7.12Web Page Ad DescriptionAds triggered by searches for "arthritis" running for 6 months
..... rm4.7.19eHealth Portaltrue
..... rm4.7.20eHealthPortal DescriptioneHealth Portal message to all patients in the Central Campus Test University eHealth Portal with arthritis diagnosis codes
.... rm4.8Will Direct Communication Materials be Utilized?expandedYes-NoIndicator N: No
.... rm4.10Will Group Communication Materials be Utilized?expandedYes-NoIndicator N: No
.... rm4.12Will Public Communication Materials be Utilized?expandedYes-NoIndicator N: No
.... rm4.33Attachments for Broadcast Communication Recruitment Materials
..... rm4.33.1Describe the file that is being attached (optional)TV Spot
..... rm4.33.2AttachmentNo display for Attachment
.... rm4.35Attachments for Printed Communication Recruitment Materials
..... rm4.35.1Describe the file that is being attached (optional)Billboard Ad
..... rm4.35.2AttachmentNo display for Attachment
.... rm4.35Attachments for Printed Communication Recruitment Materials
..... rm4.35.1Describe the file that is being attached (optional)Postcard
..... rm4.35.2AttachmentNo display for Attachment
.... rm4.37Attachments for Electronic Communication Recruitment Materials
..... rm4.37.1Describe the file that is being attached (optional)Web Page Advertising
..... rm4.37.2AttachmentNo display for Attachment
.... rm4.37Attachments for Electronic Communication Recruitment Materials
..... rm4.37.1Describe the file that is being attached (optional)eHealth Portal message
..... rm4.37.2AttachmentNo display for Attachment
... rm6Distribution List and Audience Identification
.... rm6.1If recruitment material is being mailed, emailed, texted or otherwise distributed, describe where/how the distribution list will be obtained.All patients in the Central Campus Test University eHealth Portal with arthritis diagnosis codes.
.... rm6.2Describe 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)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".
.... rm6.3Any necessary permission will be obtained for posting/airing these (for example, permission to post a flyer on a bulletin board).expandedYes-NoIndicator Y: Yes
... rm7Response to Recruitment Materials
.... rm7.1When potential participants respond to recruitment material, describe the information that will be provided to them about the study.Inclusion and exclusion criteria, study length, study goals, explanation of a double-blind study and enrollment process.
.... rm7.2Describe 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.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.
.... rm7.3Types of communication methods that will be used to reply to potential participants who respond to recruitment materials
.... rm7.4Attach the telephone call script for responding to potential participants
..... rm7.4.1Describe the file that is being attached (optional)Telephone call reply script
..... rm7.4.2AttachmentNo display for Attachment
.... rm7.5Attach the voice mail/telephone voice message script for responding to potential participants
..... rm7.5.1Describe the file that is being attached (optional)Voice mail/telephone voice message script
..... rm7.5.2AttachmentNo display for Attachment
.... rm7.7Attach the email script for responding to potential participants
..... rm7.7.1Describe the file that is being attached (optional)Email reply message
..... rm7.7.2AttachmentNo display for Attachment
.... rm7.9Attach the eHealth Portal messaging script for responding to potential participants
..... rm7.9.1Describe the file that is being attached (optional)eHealth Portal reply message
..... rm7.9.2AttachmentNo display for Attachment
... ADMIN00Administrative Use Only
.... ADMIN01Link ID prefixrm
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if anyinitiate-study-populate-exampleQR
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire ResponsesResearchStudyExample-sIRB

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