Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use

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

LinkId | Text | Definition | Answer
--- | --- | --- | ---
recruitment-populate-exampleQR |  | QuestionnaireResponse |
rm1 | Research Study |  |
rm1.1 | Study Title |  | Study of Drug A for arthritis
rm1.2 | IRB Protocol Number |  | PRO098765
rm9 | Submission Type and Relying Site Selection (if applicable) |  |
rm9.1 | Is this Recruitment Materials Form being submitted to request approval for the recruitment materials for the overall study? |  | expandedYes-NoIndicator N: No
ExternalDataFor_rm9.2 | External Data For linkId rm9.2 |  |
rm9.2 | If 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
rm2 | Study Institution for which Recruitment Materials are being provided |  |
rm2.1 | Institution Name |  | Central Campus Test University
rm2.2 | City |  | Central
rm2.3 | State |  | MI
rm2.4 | Country |  | United States
rm3 | Site Principal Investigator for the Site for which Recruitment Materials are being submitted |  |
rm3.1 | First Name |  | Maria
rm3.3 | Last Name |  | Smith
rm3.4 | Degree(s) |  | PhD
rm4 | Recruitment Materials |  |
rm4.1 | Will Recruitment Materials be Utilized? |  | expandedYes-NoIndicator Y: Yes
rm4.2 | Will Broadcast Materials be Utilized? |  | expandedYes-NoIndicator Y: Yes
rm4.3 | Broadcast Communication |  |
rm4.3.7 | TV Spot |  | true
rm4.3.8 | TV Spot Description |  | 30 second TV ad airing once daily for 4 weeks during nightly news on TV news show with most viewers this year
rm4.4 | Will Printed Materials be Utilized? |  | expandedYes-NoIndicator Y: Yes
rm4.5 | Printed Communication |  |
rm4.5.1 | Billboard/Bus Ad |  | true
rm4.5.2 | Billboard/Bus Ad Description |  | Billboard for 6 months on 3 interstate highway locations in MI once study opens for enrollment
rm4.5.13 | Postcard |  | true
rm4.5.14 | Postcard Description |  | Postcard 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
rm4.6 | Will Electronic Materials be Utilized? |  | expandedYes-NoIndicator Y: Yes
rm4.7 | Electronic Communication |  |
rm4.7.11 | Web Page Advertising |  | true
rm4.7.12 | Web Page Ad Description |  | Ads triggered by searches for "arthritis" running for 6 months
rm4.7.19 | eHealth Portal |  | true
rm4.7.20 | eHealthPortal Description |  | eHealth Portal message to all patients in the Central Campus Test University eHealth Portal with arthritis diagnosis codes
rm4.8 | Will Direct Communication Materials be Utilized? |  | expandedYes-NoIndicator N: No
rm4.10 | Will Group Communication Materials be Utilized? |  | expandedYes-NoIndicator N: No
rm4.12 | Will Public Communication Materials be Utilized? |  | expandedYes-NoIndicator N: No
rm4.33 | Attachments for Broadcast Communication Recruitment Materials |  |
rm4.33.1 | Describe the file that is being attached (optional) |  | TV Spot
rm4.33.2 | Attachment |  | No display for Attachment
rm4.35 | Attachments for Printed Communication Recruitment Materials |  |
rm4.35.1 | Describe the file that is being attached (optional) |  | Billboard Ad
rm4.35.2 | Attachment |  | No display for Attachment
rm4.35 | Attachments for Printed Communication Recruitment Materials |  |
rm4.35.1 | Describe the file that is being attached (optional) |  | Postcard
rm4.35.2 | Attachment |  | No display for Attachment
rm4.37 | Attachments for Electronic Communication Recruitment Materials |  |
rm4.37.1 | Describe the file that is being attached (optional) |  | Web Page Advertising
rm4.37.2 | Attachment |  | No display for Attachment
rm4.37 | Attachments for Electronic Communication Recruitment Materials |  |
rm4.37.1 | Describe the file that is being attached (optional) |  | eHealth Portal message
rm4.37.2 | Attachment |  | No display for Attachment
rm6 | Distribution List and Audience Identification |  |
rm6.1 | If 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.
rm6.2 | 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) |  | 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".
rm6.3 | Any necessary permission will be obtained for posting/airing these (for example, permission to post a flyer on a bulletin board). |  | expandedYes-NoIndicator Y: Yes
rm7 | Response to Recruitment Materials |  |
rm7.1 | When 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.
rm7.2 | 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. |  | 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.
rm7.3 | Types of communication methods that will be used to reply to potential participants who respond to recruitment materials |  |
rm7.4 | Attach the telephone call script for responding to potential participants |  |
rm7.4.1 | Describe the file that is being attached (optional) |  | Telephone call reply script
rm7.4.2 | Attachment |  | No display for Attachment
rm7.5 | Attach the voice mail/telephone voice message script for responding to potential participants |  |
rm7.5.1 | Describe the file that is being attached (optional) |  | Voice mail/telephone voice message script
rm7.5.2 | Attachment |  | No display for Attachment
rm7.7 | Attach the email script for responding to potential participants |  |
rm7.7.1 | Describe the file that is being attached (optional) |  | Email reply message
rm7.7.2 | Attachment |  | No display for Attachment
rm7.9 | Attach the eHealth Portal messaging script for responding to potential participants |  |
rm7.9.1 | Describe the file that is being attached (optional) |  | eHealth Portal reply message
rm7.9.2 | Attachment |  | No display for Attachment
ADMIN00 | Administrative Use Only |  |
ADMIN01 | Link ID prefix |  | rm
ADMIN02 | Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any |  | initiate-study-populate-exampleQR
ADMIN03 | ID of the Research Study FHIR Resource associated with the study Questionnaire Responses |  | ResearchStudyExample-sIRB
Documentation for this format