consent-form-populate-exampleQR
type: QuestionnaireResponse
node role: treeRoot
id:
  v: consent-form-populate-exampleQR
meta:
  version id:
    v: 4
  last updated:
    v: 2022-06-20T02:33:03.598+00:00
text:
  status:
    v: generated
  div: LinkId Text Definition Answer<img src="[binary]" alt="doco" style="background-color: inherit"/> consent-form-populate-exampleQR QuestionnaireResponse c1 Research Study c1.1 Study Title Study of Drug A for arthritis c1.2 IRB Protocol Number PRO098765 c38 Study Site ExternalDataFor_c38.1 External Data For linkId c38.1 c38.1 Select the relying site that this consent form pertains to, in order to pre-populate the relying institution and relying site principal investigator details below. [not stated] : Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA c38.2 Is this relying site also functioning as the lead site for the overall study with the lead PI for the overall study as the site PI? expandedYes-NoIndicator N: No c40 Study Site Principal Investigator and Study Site c40.1 Multi-site statement This research study is part of a multi-site research study. There are other institutions with participants this study. Later in this consent form, more details about the number of participants and sites will be discussed. c40.3 Statement for Consent Form at Relying Site (not Lead PI Site) This consent form describes your involvement in research at the study site listed below. The site principal investigator (PI) is responsible for the conduct of the study at this site. c40.5 Principal Investigator at Study Site c40.5.2 First Name Xi-Yang c40.5.1 Last Name Lee c40.5.6 Suffix Jr. c40.5.3 Degree(s) MD, PhD c40.5.4 Associated Institution Test Example University c40.5.8 Contact Information c40.5.8.20 Phone 6781233456 c40.5.8.21 Email XiYangLee@teu.med.edu c40.9 Study Site Institution c40.9.1 Institution Name Test Example University c40.9.2 Address c40.9.2.10 Street Address 200 Test Example Circle c40.9.2.11 City Example c40.9.2.12 State MA c40.9.2.13 Zip Code 67890 c40.9.2.14 Country United States c49 Lead Principal Investigator and Lead Principal Investigator Site c49.1 Statement about Lead PI and Lead PI Site for Consent Form at Relying Site In multi-site studies, t…
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/workflow-researchStudy
  value: Reference
    link: http://hl7.org/fhir/us/sirb/ResearchStudy/ResearchStudyExample-sIRB
    reference:
      v: ResearchStudy/ResearchStudyExample-sIRB
    display:
      v: ResearchStudyExample-sIRB
questionnaire:
  v: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire-populate
  link: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire-populate
status:
  v: completed
authored:
  v: 2022-06-20T02:32:56.919Z
item:
  link id:
    v: c1
  text:
    v: Research Study
  item:
    link id:
      v: c1.1
    text:
      v: Study Title
    answer:
      value:
        v: Study of Drug A for arthritis
  item:
    link id:
      v: c1.2
    text:
      v: IRB Protocol Number
    answer:
      value:
        v: PRO098765
item:
  link id:
    v: c38
  text:
    v: Study Site
  item:
    link id:
      v: ExternalDataFor_c38.1
    text:
      v: External Data For linkId c38.1
    answer:
      value:
        v: Sample University Medical Center | | Jane Doe, MD | Sample City, NC
    answer:
      value:
        v: Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA
    answer:
      value:
        v: Central Campus Test University | | Maria Smith, PhD | Central, MI
  item:
    link id:
      v: c38.1
    text:
      v: Select the relying site that this consent form pertains to, in order to pre-populate the relying institution and relying site principal investigator details below.
    answer:
      value: Coding
  item:
    link id:
      v: c38.2
    text:
      v: Is this relying site also functioning as the lead site for the overall study with the lead PI for the overall study as the site PI?
    answer:
      value: Coding
item:
  link id:
    v: c40
  text:
    v: Study Site Principal Investigator and Study Site
  item:
    link id:
      v: c40.1
    text:
      v: Multi-site statement
    answer:
      value:
        v: This research study is part of a multi-site research study. There are other institutions with participants this study. Later in this consent form, more details about the number of participants and sites will be discussed.
  item:
    link id:
      v: c40.3
    text:
      v: Statement for Consent Form at Relying Site (not Lead PI Site)
    answer:
      value:
        v: This consent form describes your involvement in research at the study site listed below. The site principal investigator (PI) is responsible for the conduct of the study at this site.
  item:
    link id:
      v: c40.5
    text:
      v: Principal Investigator at Study Site
    item:
      link id:
        v: c40.5.2
      text:
        v: First Name
    item:
      link id:
        v: c40.5.1
      text:
        v: Last Name
    item:
      link id:
        v: c40.5.6
      text:
        v: Suffix
    item:
      link id:
        v: c40.5.3
      text:
        v: Degree(s)
    item:
      link id:
        v: c40.5.4
      text:
        v: Associated Institution
    item:
      link id:
        v: c40.5.8
      text:
        v: Contact Information
  item:
    link id:
      v: c40.9
    text:
      v: Study Site Institution
    item:
      link id:
        v: c40.9.1
      text:
        v: Institution Name
    item:
      link id:
        v: c40.9.2
      text:
        v: Address
item:
  link id:
    v: c49
  text:
    v: Lead Principal Investigator and Lead Principal Investigator Site
  item:
    link id:
      v: c49.1
    text:
      v: Statement about Lead PI and Lead PI Site for Consent Form at Relying Site
    answer:
      value:
        v: In multi-site studies, there is a lead institution that is responsible for the overall coordination of the study. The lead institution has a lead Principal Investigator who is responsible for the overall conduct of the study. The lead site and lead Principal Investigator are listed here for your information.
  item:
    link id:
      v: c49.2
    text:
      v: Lead Principal Investigator
    item:
      link id:
        v: c49.2.2
      text:
        v: First Name
    item:
      link id:
        v: c49.2.1
      text:
        v: Last Name
    item:
      link id:
        v: c49.2.3
      text:
        v: Degree(s)
    item:
      link id:
        v: c49.2.5
      text:
        v: Contact Information
  item:
    link id:
      v: c49.5
    text:
      v: Lead Principal Investigator Institution
    item:
      link id:
        v: c49.5.1
      text:
        v: Name

v: Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA

v: N

v: No

v: Xi-Yang

v: Lee

v: Jr.

v: MD, PhD

v: Test Example University

v: c40.5.8.20

v: Phone

value:
  v: 6781233456

v: c40.5.8.21

v: Email

v: Test Example University

v: c40.9.2.10

v: Street Address

value:
  v: 200 Test Example Circle

v: c40.9.2.11

v: City

value:
  v: Example

v: c40.9.2.12

v: State

value:
  v: MA

v: c40.9.2.13

v: Zip Code

value:
  v: 67890

v: c40.9.2.14

v: Country

value:
  v: United States

v: Jane

v: Doe

v: MD

v: c49.2.5.20

v: Phone

value:
  v: 567-123-1234

v: c49.2.5.21

v: Email

v: Sample University Medical Center

link id:
  v: c49.5.2
text:
  v: Address
item:
  link id:
    v: c49.5.2.10
  text:
    v: Street Address
  answer:
    value:
      v: 105 Sample University Ct.
item:
  link id:
    v: c49.5.2.11
  text:
    v: City
  answer:
    value:
      v: Sample City
item:
  link id:
    v: c49.5.2.12
  text:
    v: State
  answer:
    value:
      v: NC
item:
  link id:
    v: c49.5.2.13
  text:
    v: Zip Code
  answer:
    value:
      v: 27612
item:
  link id:
    v: c49.5.2.14
  text:
    v: Country
  answer:
    value:
      v: United States

link id:
  v: c4
text:
  v: Sponsor or Funding Source
item:
  link id:
    v: ExternalDataFor_c4.1
  text:
    v: External Data For linkId c4.1
  answer:
    value:
      v: National Government Funder
  answer:
    value:
      v: Organization of Arthritis Patients Foundation
item:
  link id:
    v: c4.1
  text:
    v: Sponsor Name
  answer:
    value: Coding
      display:
        v: National Government Funder
  answer:
    value: Coding
      display:
        v: Organization of Arthritis Patients Foundation

link id:
  v: c6
text:
  v: Is this consent an eConsent?
answer:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No

link id:
  v: c7
text:
  v: Summary Text
item:
  link id:
    v: c7.1
  text:
    v: Summary Text Statement
  answer:
    value:
      v: This field should contain a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

link id:
  v: c8
text:
  v: Introduction and Statement of Research
item:
  link id:
    v: c8.1
  text:
    v: About Consent Form
  answer:
    value:
      v: This consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision. Please read this form carefully and ask questions about anything that is not clear before you agree to participate. We encourage you to discuss this research with family or friends before consenting to participate.

link id:
  v: c9
text:
  v: Purpose
item:
  link id:
    v: c9.1
  text:
    v: Reason for Research
  answer:
    value:
      v: This study is to determine the efficacy of Drug A for arthritis and whether it is more effective than the standard of care treatment.
item:
  link id:
    v: c9.2
  text:
    v: Interactions with others
  answer:
    value:
      v: Participants can expect to interact with the study coordinator during their visits, with some other personnel providing clinical services and procedures.
item:
  link id:
    v: c9.3
  text:
    v: Invited Participants
  answer:
    value:
      v: Candidates for this study include patients suffering from arthritis.
item:
  link id:
    v: c9.4
  text:
    v: Total expected study enrollment
  answer:
    value:
      v: 500
item:
  link id:
    v: c9.5
  text:
    v: Additional Enrollment Text
  answer:
    value:
      v: Additional Text can be inserted here.
item:
  link id:
    v: c9.6
  text:
    v: What is involved in the study?
  answer:
    value:
      v: This study will involve an initial visit for collection of health history and demographic data, a baseline clinical visit, a follow up visit and an end of study clinical visit.

link id:
  v: c10
text:
  v: Assessments
item:
  link id:
    v: c10.1
  text:
    v: Assessment List
  item:
    link id:
      v: c10.1.1
    text:
      v: Name of the Assessment
    answer:
      value:
        v: Initial health history and demographic data survey
  item:
    link id:
      v: c10.1.2
    text:
      v: Description of Assessment
    answer:
      value:
        v: Participants will be asked about health history and demographic background
item:
  link id:
    v: c10.1
  text:
    v: Assessment List
  item:
    link id:
      v: c10.1.1
    text:
      v: Name of the Assessment
    answer:
      value:
        v: Baseline Blood Draw
  item:
    link id:
      v: c10.1.2
    text:
      v: Description of Assessment
    answer:
      value:
        v: 4 tubes of blood will be drawn
item:
  link id:
    v: c10.1
  text:
    v: Assessment List
  item:
    link id:
      v: c10.1.1
    text:
      v: Name of the Assessment
    answer:
      value:
        v: Recurring monthly blood draws
  item:
    link id:
      v: c10.1.2
    text:
      v: Description of Assessment
    answer:
      value:
        v: 2 tubes of blood will be drawn
item:
  link id:
    v: c10.1
  text:
    v: Assessment List
  item:
    link id:
      v: c10.1.1
    text:
      v: Name of the Assessment
    answer:
      value:
        v: End of Study Blood Draw
  item:
    link id:
      v: c10.1.2
    text:
      v: Description of Assessment
    answer:
      value:
        v: 4 tubes of blood will be drawn
item:
  link id:
    v: c10.2
  text:
    v: Assessment Supplemental Text
  answer:
    value:
      v: Additional Text about the assessments can be included here.
item:
  link id:
    v: c10.3
  text:
    v: Do you want to upload the "Assessment List" table instead of typing the assessments directly into this questionnaire?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No

link id:
  v: c11
text:
  v: Visits and Procedures
item:
  link id:
    v: c11.1
  text:
    v: Visit Introductory Text
  answer:
    value:
      v: explain any additional detail or information about the visit schedule.
item:
  link id:
    v: c11.2
  text:
    v: Visit List
  item:
    link id:
      v: c11.2.1
    text:
      v: Visit Type
    answer:
      value:
        v: Initial visit
  item:
    link id:
      v: c11.2.2
    text:
      v: Visit Description
    answer:
      value:
        v: Collection of health history and demographic data
  item:
    link id:
      v: c11.2.3
    text:
      v: Visit Duration
    answer:
      value:
        v: 2
  item:
    link id:
      v: c11.2.4
    text:
      v: Visit Duration Units
    answer:
      value: Coding
  item:
    link id:
      v: c11.2.5
    text:
      v: Number of Visits
    answer:
      value:
        v: 1
item:
  link id:
    v: c11.2
  text:
    v: Visit List
  item:
    link id:
      v: c11.2.1
    text:
      v: Visit Type
    answer:
      value:
        v: Baseline Visit
  item:
    link id:
      v: c11.2.2
    text:
      v: Visit Description
    answer:
      value:
        v: Collection of baseline measures
  item:
    link id:
      v: c11.2.3
    text:
      v: Visit Duration
    answer:
      value:
        v: 1
  item:
    link id:
      v: c11.2.4
    text:
      v: Visit Duration Units
    answer:
      value: Coding
  item:
    link id:
      v: c11.2.5
    text:
      v: Number of Visits
    answer:
      value:
        v: 1
item:
  link id:
    v: c11.2
  text:
    v: Visit List
  item:
    link id:
      v: c11.2.1
    text:
      v: Visit Type
    answer:
      value:
        v: Follow up Visit
  item:
    link id:
      v: c11.2.2
    text:
      v: Visit Description
    answer:
      value:
        v: Recurring monthly visits for blood draw and weight check
  item:
    link id:
      v: c11.2.3
    text:
      v: Visit Duration
    answer:
      value:
        v: 30
  item:
    link id:
      v: c11.2.4
    text:
      v: Visit Duration Units
    answer:
      value: Coding
  item:
    link id:
      v: c11.2.5
    text:
      v: Number of Visits
    answer:
      value:
        v: 6
item:
  link id:
    v: c11.2
  text:
    v: Visit List
  item:
    link id:
      v: c11.2.1
    text:
      v: Visit Type
    answer:
      value:
        v: End of study visit
  item:
    link id:
      v: c11.2.2
    text:
      v: Visit Description
    answer:
      value:
        v: Collection of end of study measures
  item:
    link id:
      v: c11.2.3
    text:
      v: Visit Duration
    answer:
      value:
        v: 1
  item:
    link id:
      v: c11.2.4
    text:
      v: Visit Duration Units
    answer:
      value: Coding
  item:
    link id:
      v: c11.2.5
    text:
      v: Number of Visits
    answer:
      value:
        v: 1
item:
  link id:
    v: c11.6
  text:
    v: Do you want to upload the "Visit List" table instead of typing the visits directly into this questionnaire?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No

v: h

v: h

v: h

v: h

v: min

v: min

v: h

v: h

link id:
  v: c11.3
text:
  v: Procedure List
item:
  link id:
    v: c11.3.1
  text:
    v: Name of Procedure
  answer:
    value:
      v: Weight check
item:
  link id:
    v: c11.3.2
  text:
    v: Common Term of Procedure
  answer:
    value:
      v: Weight check
item:
  link id:
    v: c11.3.3
  text:
    v: Description of a Procedure
  answer:
    value:
      v: Participants will be weighed on a scale
item:
  link id:
    v: c11.3.4
  text:
    v: Experimental Procedure Indicator
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: c11.3.5
  text:
    v: Research Indicator
  answer:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: STDCR
      display:
        v: Standard of Care
item:
  link id:
    v: c11.3.6
  text:
    v: Frequency
  answer:
    value:
      v: At baseline visit, at end of study visit and at monthly follow up visits
item:
  link id:
    v: c11.3.9
  text:
    v: Procedure Duration (minutes)
  answer:
    value:
      v: 1

link id:
  v: c11.3
text:
  v: Procedure List
item:
  link id:
    v: c11.3.1
  text:
    v: Name of Procedure
  answer:
    value:
      v: Baseline visit and End of Study visit Venipuncture
item:
  link id:
    v: c11.3.2
  text:
    v: Common Term of Procedure
  answer:
    value:
      v: Blood Draw
item:
  link id:
    v: c11.3.3
  text:
    v: Description of a Procedure
  answer:
    value:
      v: Phelebotomist will draw 4 tubes of blood at Baseline visit and End of Study visit
item:
  link id:
    v: c11.3.4
  text:
    v: Experimental Procedure Indicator
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: c11.3.5
  text:
    v: Research Indicator
  answer:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: STDCR
      display:
        v: Standard of Care
item:
  link id:
    v: c11.3.6
  text:
    v: Frequency
  answer:
    value:
      v: At Baseline visit and End of Study visit
item:
  link id:
    v: c11.3.9
  text:
    v: Procedure Duration (minutes)
  answer:
    value:
      v: 20

link id:
  v: c11.3
text:
  v: Procedure List
item:
  link id:
    v: c11.3.1
  text:
    v: Name of Procedure
  answer:
    value:
      v: Recurring monthly Venipuncture
item:
  link id:
    v: c11.3.2
  text:
    v: Common Term of Procedure
  answer:
    value:
      v: Blood Draw
item:
  link id:
    v: c11.3.3
  text:
    v: Description of a Procedure
  answer:
    value:
      v: Phelebotomist will draw 2 tubes of blood monthly
item:
  link id:
    v: c11.3.4
  text:
    v: Experimental Procedure Indicator
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: c11.3.5
  text:
    v: Research Indicator
  answer:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: STDCR
      display:
        v: Standard of Care
item:
  link id:
    v: c11.3.6
  text:
    v: Frequency
  answer:
    value:
      v: monthly
item:
  link id:
    v: c11.3.9
  text:
    v: Procedure Duration (minutes)
  answer:
    value:
      v: 15

link id:
  v: c11.4
text:
  v: Procedure Supplemental Text
answer:
  value:
    v: Additional Text can be captured here

link id:
  v: c11.9
text:
  v: Do you want to upload the "Procedure List" table instead of typing the procedures directly into this questionnaire?
answer:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No

link id:
  v: c11.5
text:
  v: Total Duration of Study Participation
answer:
  value:
    v: 7 months

link id:
  v: c12
text:
  v: Risks
item:
  link id:
    v: c12.1
  text:
    v: Risk List
  item:
    link id:
      v: c12.1.1
    text:
      v: Name of the risk
    answer:
      value:
        v: Bruising
  item:
    link id:
      v: c12.1.2
    text:
      v: Description of Risk
    answer:
      value:
        v: Blood draw may cause some mild bruising
  item:
    link id:
      v: c12.1.3
    text:
      v: Risk Category
    answer:
      value: Coding
item:
  link id:
    v: c12.9
  text:
    v: Do you want to upload the "Risk List" table instead of typing the risks directly into this questionnaire?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: c12.2
  text:
    v: Risk Supplemental Text
  answer:
    value:
      v: Additional risk text can be included here
item:
  link id:
    v: c12.3
  text:
    v: Fetal Risks
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No

v: PHYS

v: Physical

link id:
  v: c13
text:
  v: Alternative Procedures
item:
  link id:
    v: c13.1
  text:
    v: Alternative Procedure Text
  answer:
    value:
      v: Participants are free to not participate at no additional risk.

link id:
  v: c14
text:
  v: Benefits
item:
  link id:
    v: c14.1
  text:
    v: Benefits List
  item:
    link id:
      v: c14.1.1
    text:
      v: Name of Benefit
    answer:
      value:
        v: Societal Benefit of additional knowledge
  item:
    link id:
      v: c14.1.2
    text:
      v: Description of Benefit
    answer:
      value:
        v: Societal Benefit
  item:
    link id:
      v: c14.1.3
    text:
      v: Benefit to you
    answer:
      value: Coding
  item:
    link id:
      v: c14.1.4
    text:
      v: Benefit to society
    answer:
      value: Coding
item:
  link id:
    v: c14.9
  text:
    v: Do you want to upload the "Benefits List" table instead of typing the benefits directly into this questionnaire?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No

v: N

v: No

v: Y

v: Yes

link id:
  v: c15
text:
  v: Compensation
item:
  link id:
    v: c15.1
  text:
    v: Will there be compensation for participation?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: c15.2
  text:
    v: Compensation Supplemental Text
  answer:
    value:
      v: Description of compensation can be included
item:
  link id:
    v: c15.3
  text:
    v: Compensation List
  item:
    link id:
      v: c15.3.1
    text:
      v: What types of visits or milestones will I be compensated for?
    answer:
      value:
        v: Baseline
  item:
    link id:
      v: c15.3.2
    text:
      v: How many visits or milestones of this type will there be compensation for?
    answer:
      value:
        v: 1
  item:
    link id:
      v: c15.3.3
    text:
      v: How much will be paid per that type of visit?
    answer:
      value:
        v: 100
item:
  link id:
    v: c15.3
  text:
    v: Compensation List
  item:
    link id:
      v: c15.3.1
    text:
      v: What types of visits or milestones will I be compensated for?
    answer:
      value:
        v: Followup
  item:
    link id:
      v: c15.3.2
    text:
      v: How many visits or milestones of this type will there be compensation for?
    answer:
      value:
        v: 6
  item:
    link id:
      v: c15.3.3
    text:
      v: How much will be paid per that type of visit?
    answer:
      value:
        v: 25
item:
  link id:
    v: c15.3
  text:
    v: Compensation List
  item:
    link id:
      v: c15.3.1
    text:
      v: What types of visits or milestones will I be compensated for?
    answer:
      value:
        v: End of Study visit
  item:
    link id:
      v: c15.3.2
    text:
      v: How many visits or milestones of this type will there be compensation for?
    answer:
      value:
        v: 1
  item:
    link id:
      v: c15.3.3
    text:
      v: How much will be paid per that type of visit?
    answer:
      value:
        v: 100
item:
  link id:
    v: c15.5
  text:
    v: Do you want to upload the "Compensation List" table instead of typing the risks directly into this questionnaire?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No

link id:
  v: c17
text:
  v: Participant Rights and whom to contact for answers
item:
  link id:
    v: c17.2
  text:
    v: Site IRB Contact Information
  item:
    link id:
      v: c17.2.8
    text:
      v: IRB Name
    answer:
      value:
        v: X Pharmaceutical Research IRB
  item:
    link id:
      v: c17.2.10
    text:
      v: Street Address
    answer:
      value:
        v: 210 Research Drive
  item:
    link id:
      v: c17.2.11
    text:
      v: City
    answer:
      value:
        v: Sample City
  item:
    link id:
      v: c17.2.12
    text:
      v: State
    answer:
      value:
        v: NC
  item:
    link id:
      v: c17.2.13
    text:
      v: Zip Code
    answer:
      value:
        v: 27612
  item:
    link id:
      v: c17.2.14
    text:
      v: Country
    answer:
      value:
        v: United States
item:
  link id:
    v: c17.3
  text:
    v: Study Coordinator Contact Information
  item:
    link id:
      v: c17.3.1
    text:
      v: Study Coordinator Name
    answer:
      value:
        v: [Study Coordinator Contact Information]
  item:
    link id:
      v: c17.3.8
    text:
      v: Study Coordinator Institution or Organization
    answer:
      value:
        v: [Study Coordinator Contact Information]
  item:
    link id:
      v: c17.3.9
    text:
      v: Department Name or Division
    answer:
      value:
        v: [Study Coordinator Contact Information]
  item:
    link id:
      v: c17.3.10
    text:
      v: Street Address
    answer:
      value:
        v: [Study Coordinator Contact Information]
  item:
    link id:
      v: c17.3.11
    text:
      v: City
    answer:
      value:
        v: [Study Coordinator Contact Information]
  item:
    link id:
      v: c17.3.12
    text:
      v: State
    answer:
      value:
        v: [Study Coordinator Contact Information]
  item:
    link id:
      v: c17.3.13
    text:
      v: Zip Code
    answer:
      value:
        v: [Study Coordinator Contact Information]
  item:
    link id:
      v: c17.3.14
    text:
      v: Country
    answer:
      value:
        v: [Study Coordinator Contact Information]
  item:
    link id:
      v: c17.3.20
    text:
      v: Phone
    answer:
      value:
        v: [Study Coordinator Contact Information]
  item:
    link id:
      v: c17.3.21
    text:
      v: Email
    answer:
      value:
        v: [Study Coordinator Contact Information]
item:
  link id:
    v: c17.4
  text:
    v: Site Principal Investigator Contact Information
  item:
    link id:
      v: c17.4.1
    text:
      v: Site Principal Investigator Name
    answer:
      value:
        v: Xi-Yang Lee, Jr., MD, PhD
  item:
    link id:
      v: c17.4.8
    text:
      v: Site Principal Investigator Institution
    answer:
      value:
        v: Test Example University
  item:
    link id:
      v: c17.4.10
    text:
      v: Street Address
    answer:
      value:
        v: 200 Test Example Circle
  item:
    link id:
      v: c17.4.11
    text:
      v: City
    answer:
      value:
        v: Example
  item:
    link id:
      v: c17.4.12
    text:
      v: State
    answer:
      value:
        v: MA
  item:
    link id:
      v: c17.4.13
    text:
      v: Zip Code
    answer:
      value:
        v: 67890
  item:
    link id:
      v: c17.4.14
    text:
      v: Country
    answer:
      value:
        v: United States

link id:
  v: c17.4.20
text:
  v: Phone
answer:
  value:
    v: 6781233456

link id:
  v: c17.4.21
text:
  v: Email

link id:
  v: c18
text:
  v: Participation
item:
  link id:
    v: c18.1
  text:
    v: Voluntary Permission Statement
  answer:
    value:
      v: Participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
item:
  link id:
    v: c18.2
  text:
    v: What are the anticipated circumstances under which participant's participation may be terminated by the investigator without regard to the participant's or the legally authorized representative's consent.
  answer:
    value:
      v: Participants can be removed from the study if their condition changes such that the study procedures are not advised for their existing conditions.

link id:
  v: c19
text:
  v: Early Withdrawal
item:
  link id:
    v: c19.1
  text:
    v: Are there consequences to participant for early withdrawal?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: c19.2
  text:
    v: Are there Emotional Consequences of Withdrawal
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: c19.3
  text:
    v: Are there Physical Consequences of Withdrawal
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: c19.4
  text:
    v: What are the consequences of withdrawal?
  answer:
    value:
      v: Consequences of withdrawal should be included here.

link id:
  v: c20
text:
  v: Confidentiality of Records
item:
  link id:
    v: c20.1
  text:
    v: Will HIPAA content be included within this document?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: c20.2
  text:
    v: Medical information and billing statement
  answer:
    value:
      v: Medical information and billing records are protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA). This type of information is called protected health information (PHI). PHI about you may be obtained from any hospital, doctor, and other health care provider involved in your care.
item:
  link id:
    v: c20.3
  text:
    v: Will confidentiality be protected?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: c20.5
  text:
    v: Are there data security or policies that need to be included in the consent, particularly around device use (optional)
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: c20.7
  text:
    v: Who can use or see participant information?
  item:
    link id:
      v: c20.7.1
    text:
      v: Role or group who will have access to data
    answer:
      value: Coding
  item:
    link id:
      v: c20.7.2
    text:
      v: Description of Information Disclosed
    answer:
      value:
        v: Deidentified demographic data
item:
  link id:
    v: c20.7
  text:
    v: Who can use or see participant information?
  item:
    link id:
      v: c20.7.1
    text:
      v: Role or group who will have access to data
    answer:
      value: Coding
  item:
    link id:
      v: c20.7.2
    text:
      v: Description of Information Disclosed
    answer:
      value:
        v: Deidentified demographic data
item:
  link id:
    v: c20.8
  text:
    v: Will the data be released for future use?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: c20.9
  text:
    v: Will the future use data be deidentified?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: c20.10
  text:
    v: Deidentification detail
  answer:
    value:
      v: Only demographic data will be shared
item:
  link id:
    v: c20.11
  text:
    v: Required text disclosure surrounding future use.
  answer:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: DEIDUSED
      display:
        v: Identifiers might be removed from private information or biospecimens, and this information could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent.

v: OTHINSTRES

v: Researchers at other institutions

v: THISINSTRES

v: Researchers outside the study team at this institution

link id:
  v: c21
text:
  v: Specimen Management
item:
  link id:
    v: c21.1
  text:
    v: Were specimens collected as part of this study?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: c21.2
  text:
    v: Is whole genome sequencing being conducted?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: c21.3
  text:
    v: Sharing or no Sharing of samples.
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: c21.4
  text:
    v: Conditions of sharing
  answer:
    value:
      v: Deidentified samples will be shared with other investigators at this institution.
item:
  link id:
    v: c21.5
  text:
    v: Will participant share in profit with commerical use?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: c21.6
  text:
    v: Description of Collection and Storage
  answer:
    value:
      v: Samples are stored with only a deidentified code. Only the study coordinator will retain this link, which will be destroyed at study conclusion.
item:
  link id:
    v: c21.7
  text:
    v: Can consent for sample use be revoked?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No

link id:
  v: c22
text:
  v: Will there be Broad Consent for Storage, maintenance and secondary research use?
answer:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No

link id:
  v: c23
text:
  v: Can the study team contact you for future research?
answer:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
    display:
      v: Yes
  item:
    link id:
      v: c23.1
    text:
      v: Conditions about contact for additional sample use, information not currently described or future research
    answer:
      value:
        v: Participants can be called for up to 1 year after conclusion of the study

link id:
  v: c24
text:
  v: Will participants share in commercial profit?
answer:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No

link id:
  v: c25
text:
  v: Will the study team contact you with new information that may affect your willingness to remain in the study
answer:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No

link id:
  v: c26
text:
  v: Will the study team disclose clinically relevant study results to you?
answer:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No

link id:
  v: c27
text:
  v: Clinical Trials.gov statement
answer:
  value:
    v: A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

link id:
  v: c28
text:
  v: Is this study covered under a Certificate of Confidentiality? (default Y in NIH)
answer:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No

link id:
  v: c30
text:
  v: Statement of PHI Authorization Revocation
answer:
  value:
    v: Participants have the ability to revoke their consent to share PHI at any time but that there are limitations on what restrictions can apply to data that has already been shared.

link id:
  v: c31
text:
  v: Signature
item:
  link id:
    v: c31.1
  text:
    v: Indicator to include Participant Signature and Date/Time
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: c31.2
  text:
    v: Indicator to include Assent Signature and Date/Time
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: c31.3
  text:
    v: Indicator to include Legally Authorized Representative Signature and Date/Time
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: c31.5
  text:
    v: Indicator to include a Witness Signature and Date/Time
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: c31.6
  text:
    v: Indicator to include Parent 1 Signature and Date/Time
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: c31.7
  text:
    v: Indicator to include Parent 2 Signature and Date/Time
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No

link id:
  v: c32
text:
  v: Consent Version
item:
  link id:
    v: c32.1
  text:
    v: Consent Version Number
  answer:
    value:
      v: 2
item:
  link id:
    v: c32.2
  text:
    v: sIRB Version Date of Consent
  answer:
    value:
      v: 2021-08-10
item:
  link id:
    v: c32.3
  text:
    v: Relying Site Version Date of Consent
  answer:
    value:
      v: 2021-08-10
item:
  link id:
    v: c32.6
  text:
    v: Expiration Date of Consent
  answer:
    value:
      v: 2024-08-01T03:59:59.846Z

link id:
  v: ADMIN00
text:
  v: Administrative Use Only
item:
  link id:
    v: ADMIN01
  text:
    v: Link ID prefix
  answer:
    value:
      v: c
item:
  link id:
    v: ADMIN02
  text:
    v: Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
  answer:
    value:
      v: initiate-study-populate-exampleQR
item:
  link id:
    v: ADMIN03
  text:
    v: ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any
  answer:
    value:
      v: ResearchStudyExample-sIRB