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
Submission Type and Relying Site Selection (if applicable)
Is this Recruitment Materials Form being submitted to request approval for the recruitment materials for the overall study?
Sample University Medical Center | | Jane Doe, MD | Sample City, NC
Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA
Central Campus Test University | | Maria Smith, PhD | Central, MI
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.
Study Institution for which Recruitment Materials are being provided
Site Principal Investigator for the Site for which Recruitment Materials are being submitted
30 second TV ad airing once daily for 4 weeks during nightly news on TV news show with most viewers this year
Billboard for 6 months on 3 interstate highway locations in MI once study opens for enrollment
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
Ads triggered by searches for "arthritis" running for 6 months
eHealth Portal message to all patients in the Central Campus Test University eHealth Portal with arthritis diagnosis codes
Will Direct Communication Materials be Utilized?
Will Group Communication Materials be Utilized?
Will Public Communication Materials be Utilized?
Attachments for Broadcast Communication Recruitment Materials
Describe the file that is being attached (optional)
Attachments for Printed Communication Recruitment Materials
Attachments for Electronic Communication Recruitment Materials
Distribution List and Audience Identification
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.
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".
Any necessary permission will be obtained for posting/airing these (for example, permission to post a flyer on a bulletin board).
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.
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.
Types of communication methods that will be used to reply to potential participants who respond to recruitment materials
Attach the telephone call script for responding to potential participants
Attach the voice mail/telephone voice message script for responding to potential participants
Voice mail/telephone voice message script
Attach the email script for responding to potential participants
Attach the eHealth Portal messaging script for responding to potential participants
Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
ID of the Research Study FHIR Resource associated with the study Questionnaire Responses