nme-populate-exampleQR
type: QuestionnaireResponse
node role: treeRoot
id:
  v: nme-populate-exampleQR
meta:
  version id:
    v: 1
  last updated:
    v: 2022-02-28T01:16:20.863+00:00
text:
  status:
    v: generated
  div: LinkId Text Definition Answer<img src="[binary]" alt="doco" style="background-color: inherit"/> nme-populate-exampleQR QuestionnaireResponse nme1 Research Study nme1.1 Study Title Study of Drug A for arthritis nme1.3 IRB Protocol Number PRO098765 nme1.4 Status Temporary Codes nochange: No change in research activities nme7 Organization/Site nme7.1 Where Adverse Non-Medical Event Occurred nme7.1.8 Did the Adverse Non-Medical Event occur at the lead principal investigator site? expandedYes-NoIndicator N: No nme7.1.11 Did the Adverse Non-Medical Event occur at one of the relying sites? expandedYes-NoIndicator Y: Yes ExternalDataFor_nme7.1.9 External Data For linkId nme7.1.9 nme7.1.9 If the Adverse Non-Medical Event occurred at one of the relying sites, 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 nme7.1.1 Name of organization/site where the Adverse Non-Medical Event occurred Central Campus Test University nme7.1.2 City Central nme7.1.3 State MI nme7.1.4 Country United States nme7.2 Responsibility for Adverse Non-Medical Event Reporting nme7.2.8 If the Adverse Non-Medical Event occurred at a relying site or at another organization (unrelated to the lead principal investigator organization/site or relying sites), will the lead principal investigator site be recording the Adverse Non-Medical Event? expandedYes-NoIndicator Y: Yes nme7.2.1 Name of organization/site which is recording the Adverse Non-Medical Event Sample University Medical Center nme7.2.2 City Sample City nme7.2.3 State NC nme7.2.4 Country United States nme8 Site Principal Investigator for the site where Adverse Non-Medical Event occurred nme8.1 First Name Maria nme8.4 Last Name Smith nme8.6 Degree(s) PhD nme8.2 Phone 8901231234 nme8.3 Email maria.smith@CCTU.med.edu nme3 Report nme3.1 Report Date 2022-02-27 nme3.2 Report Status Temporary Codes ini…
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-nonmedicalevent-questionnaire-populate
  link: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevent-questionnaire-populate
status:
  v: completed
authored:
  v: 2022-02-28T01:16:19.909Z
item:
  link id:
    v: nme1
  text:
    v: Research Study
  item:
    link id:
      v: nme1.1
    text:
      v: Study Title
    answer:
      value:
        v: Study of Drug A for arthritis
  item:
    link id:
      v: nme1.3
    text:
      v: IRB Protocol Number
    answer:
      value:
        v: PRO098765
  item:
    link id:
      v: nme1.4
    text:
      v: Status
    answer:
      value: Coding
item:
  link id:
    v: nme7
  text:
    v: Organization/Site
  item:
    link id:
      v: nme7.1
    text:
      v: Where Adverse Non-Medical Event Occurred
    item:
      link id:
        v: nme7.1.8
      text:
        v: Did the Adverse Non-Medical Event occur at the lead principal investigator site?
      answer:
        value: Coding
    item:
      link id:
        v: nme7.1.11
      text:
        v: Did the Adverse Non-Medical Event occur at one of the relying sites?
      answer:
        value: Coding
    item:
      link id:
        v: ExternalDataFor_nme7.1.9
      text:
        v: External Data For linkId nme7.1.9
    item:
      link id:
        v: nme7.1.9
      text:
        v: If the Adverse Non-Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the relying institution and relying site principal investigator details below.
      answer:
        value: Coding
    item:
      link id:
        v: nme7.1.1
      text:
        v: Name of organization/site where the Adverse Non-Medical Event occurred
    item:
      link id:
        v: nme7.1.2
      text:
        v: City
    item:
      link id:
        v: nme7.1.3
      text:
        v: State
    item:
      link id:
        v: nme7.1.4
      text:
        v: Country
  item:
    link id:
      v: nme7.2
    text:
      v: Responsibility for Adverse Non-Medical Event Reporting
    item:
      link id:
        v: nme7.2.8
      text:
        v: If the Adverse Non-Medical Event occurred at a relying site or at another organization (unrelated to the lead principal investigator organization/site or relying sites), will the lead principal investigator site be recording the Adverse Non-Medical Event?
      answer:
        value: Coding
    item:
      link id:
        v: nme7.2.1
      text:
        v: Name of organization/site which is recording the Adverse Non-Medical Event
    item:
      link id:
        v: nme7.2.2
      text:
        v: City
    item:
      link id:
        v: nme7.2.3
      text:
        v: State
    item:
      link id:
        v: nme7.2.4
      text:
        v: Country
item:
  link id:
    v: nme8
  text:
    v: Site Principal Investigator for the site where Adverse Non-Medical Event occurred
  item:
    link id:
      v: nme8.1
    text:
      v: First Name
    answer:
      value:
        v: Maria
  item:
    link id:
      v: nme8.4
    text:
      v: Last Name
    answer:
      value:
        v: Smith
  item:
    link id:
      v: nme8.6
    text:
      v: Degree(s)
    answer:
      value:
        v: PhD
  item:
    link id:
      v: nme8.2
    text:
      v: Phone
    answer:
      value:
        v: 8901231234
  item:
    link id:
      v: nme8.3
    text:
      v: Email
item:
  link id:
    v: nme3
  text:
    v: Report
  item:
    link id:
      v: nme3.1
    text:
      v: Report Date
    answer:
      value:
        v: 2022-02-27
  item:
    link id:
      v: nme3.2

v: nochange

v: No change in research activities

Coding
system:
  v: http://terminology.hl7.org/CodeSystem/v2-0532
code:
  v: N
display:
  v: No

Coding
system:
  v: http://terminology.hl7.org/CodeSystem/v2-0532
code:
  v: Y
display:
  v: Yes

v: Sample University Medical Center | | Jane Doe, MD | Sample City, NC

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

v: Central Campus Test University | | Maria Smith, PhD | Central, MI

Coding
display:
  v: Central Campus Test University | | Maria Smith, PhD | Central, MI

v: Central Campus Test University

v: Central

v: MI

v: United States

Coding
system:
  v: http://terminology.hl7.org/CodeSystem/v2-0532
code:
  v: Y
display:
  v: Yes

v: Sample University Medical Center

v: Sample City

v: NC

v: United States

v: Report Status

value: Coding
  system:
    v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
  code:
    v: init
  display:
    v: Initial

link id:
  v: nme3.3
text:
  v: Select at least one of the following criteria:
item:
  link id:
    v: nme3.3.4
  text:
    v: New information resulted in unexpected change in risks of the research
  answer:
    value:
      v: true
item:
  link id:
    v: nme3.3.5
  text:
    v: New or increased risk
  item:
    link id:
      v: nme3.3.5.1
    text:
      v: Date:
    answer:
      value:
        v: 2022-02-27
  item:
    link id:
      v: nme3.3.5.2
    text:
      v: Date discovered:
    answer:
      value:
        v: 2022-02-26
  item:
    link id:
      v: nme3.3.5.3
    text:
      v: Description:
    answer:
      value:
        v: [answer]
item:
  link id:
    v: nme3.3.6
  text:
    v: Unanticipated Problem Involving Risk to Participants or Others
  answer:
    value:
      v: true
item:
  link id:
    v: nme3.3.7
  text:
    v: Unanticipated Problem
  item:
    link id:
      v: nme3.3.7.1
    text:
      v: Event date:
    answer:
      value:
        v: 2022-02-26
  item:
    link id:
      v: nme3.3.7.2
    text:
      v: Date event became aware to study team:
    answer:
      value:
        v: 2022-02-27
  item:
    link id:
      v: nme3.3.7.3
    text:
      v: Event Summary:
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: nme3.3.7.4
    text:
      v: Was this event Unexpected?
    answer:
      value: Coding
  item:
    link id:
      v: nme3.3.7.5
    text:
      v: If yes, please explain:
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: nme3.3.7.6
    text:
      v: Was this event Related or Possibly Related to participation in the research?
    answer:
      value: Coding
  item:
    link id:
      v: nme3.3.7.7
    text:
      v: If yes, please explain:
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: nme3.3.7.8
    text:
      v: Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known?
    answer:
      value: Coding
  item:
    link id:
      v: nme3.3.7.9
    text:
      v: If yes, please explain:
    answer:
      value:
        v: [answer]
item:
  link id:
    v: nme3.3.10
  text:
    v: A breach of Confidentiality
  answer:
    value:
      v: false
item:
  link id:
    v: nme3.3.14
  text:
    v: Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team
  answer:
    value:
      v: true
item:
  link id:
    v: nme3.3.15
  text:
    v: Participant Complaint
  item:
    link id:
      v: nme3.3.15.1
    text:
      v: Complaint Date:
    answer:
      value:
        v: 2022-02-27
  item:
    link id:
      v: nme3.3.15.2
    text:
      v: Date received:
    answer:
      value:
        v: 2022-02-27
  item:
    link id:
      v: nme3.3.15.3
    text:
      v: Description:
    answer:
      value:
        v: [answer]

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

link id:
  v: nme4
text:
  v: Reporting
item:
  link id:
    v: nme4.1
  text:
    v: Was the Sponsor notified?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: nme4.2
  text:
    v: Notification date:
  answer:
    value:
      v: 2022-02-27
item:
  link id:
    v: nme4.3
  text:
    v: Was the IRB notified?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: nme4.4
  text:
    v: Notification date:
  answer:
    value:
      v: 2022-02-27
item:
  link id:
    v: nme4.5
  text:
    v: Were any Other Parties notified?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: nme4.6
  text:
    v: List other notified parties
  answer:
    value:
      v: [answer]

link id:
  v: nme5
text:
  v: Corrective and Preventative Action Plan
item:
  link id:
    v: nme5.1
  text:
    v: Was a Root Cause analysis performed?
  answer:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: pending
      display:
        v: Pending - Currently under development
item:
  link id:
    v: nme5.2b
  text:
    v: If pending, describe status and interim findings, if any:
  answer:
    value:
      v: [answer]
item:
  link id:
    v: nme5.3
  text:
    v: Was Corrective Action implemented?
  answer:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: pending
      display:
        v: Pending - Currently under development
item:
  link id:
    v: nme5.4
  text:
    v: If Corrective Action was implemented or is pending, provide a summary:
  answer:
    value:
      v: [answer]
item:
  link id:
    v: nme5.5
  text:
    v: Was Preventitive Action implemented?
  answer:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: completed
      display:
        v: Done, performed or completed
item:
  link id:
    v: nme5.6
  text:
    v: If Preventitive Action was implemented or is pending, provide a summary:
  answer:
    value:
      v: [answer]

link id:
  v: nme6
text:
  v: Study Protocol and Informed Consent
item:
  link id:
    v: nme6.1a
  text:
    v: Are changes required to the Study Protocol as a result of this report?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: nme6.3a
  text:
    v: Are changes required to the Informed Consent as a result of this report?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: nme6.5
  text:
    v: Are notifications or re-consenting of participants required as a result of changes in Study Protocol or Informed Consent?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: nme6.6
  text:
    v: If yes, detail how the notification and/or re-consent will occur:
  answer:
    value:
      v: [answer]

link id:
  v: nme11
text:
  v: Optional Attachments
item:
  link id:
    v: nme11.1
  text:
    v: Describe the file that is being attached (optional)
  answer:
    value:
      v: [answer]
item:
  link id:
    v: nme11.2
  text:
    v: Attachment
  answer:
    value: Attachment
      content type:
        v: application/vnd.openxmlformats-officedocument.wordprocessingml.document
      title:
        v: Example attachment.docx
      creation:
        v: 2022-02-27T22:24:16.963Z

link id:
  v: ADMIN00
text:
  v: Administrative Use Only
item:
  link id:
    v: ADMIN01
  text:
    v: Link ID prefix
  answer:
    value:
      v: nme
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
  answer:
    value:
      v: ResearchStudyExample-sIRB