medical-ae-populate-exampleQR
type: QuestionnaireResponse
node role: treeRoot
id:
  v: medical-ae-populate-exampleQR
meta:
  version id:
    v: 1
  last updated:
    v: 2022-03-12T01:53:26.773+00:00
text:
  status:
    v: generated
  div: LinkId Text Definition Answer<img src="[binary]" alt="doco" style="background-color: inherit"/> medical-ae-populate-exampleQR QuestionnaireResponse mae1 Research Study mae1.1 Study Title Study of Drug A for arthritis mae1.2 IRB Protocol Number PRO098765 mae1.3 Study Type Temporary Codes INT: Interventional mae1.4 Does this protocol require an FDA exemption? expandedYes-NoIndicator Y: Yes mae1.5 Is an IND or IDE being used in this study? expandedYes-NoIndicator Y: Yes mae4 Organization/Site mae4.1 Where Adverse Medical Event Occurred mae4.1.7 Did the Adverse Medical Event occur at the lead principal investigator site? expandedYes-NoIndicator N: No ExternalDataFor_mae4.1.1 External Data For linkId mae4.1.1 mae4.1.1 If the Adverse Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the the relying institution and relying site principal investigator details below. [not stated] : Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA mae4.1.2 Name of organization/site where the event occurred Test Example University mae4.7 Site Principal Investigator mae4.7.1 First Name Xi-Yang mae4.7.2 Last Name Lee mae4.7.5 Suffix Jr. mae4.7.6 Degree(s) MD, PhD mae4.7.3 Phone 6781233456 mae4.7.4 Email XiYangLee@teu.med.edu mae4.9 Responsibility for Adverse Medical Event Reporting mae4.9.1 If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be recording the Adverse Non-Medical Event? expandedYes-NoIndicator Y: Yes mae4.9.2 Name of organization/site which is recording the Adverse Medical event Sample University Medical Center mae3 Primary Contact mae3.1 First Name Jane mae3.2 Last Name Doe mae3.3 Phone 567-123-1234 mae3.4 Email drjanedoe@sampleuniversity.edu mae5 Participant Information mae5.1 Patient ID 12345 mae5.2 Age 58 mae5.3 Birth Sex administrativeSex M: Male mae5.4 Weight 245 [lb] mae5.5 Height 67 [in] mae5.6 Ethnicity Ethnicity 2186-5: Not Hispanic or Latino mae5.7 Race R…
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-adverse-event-questionnaire-populate
  link: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate
status:
  v: completed
authored:
  v: 2022-03-12T01:53:25.336Z
item:
  link id:
    v: mae1
  text:
    v: Research Study
  item:
    link id:
      v: mae1.1
    text:
      v: Study Title
    answer:
      value:
        v: Study of Drug A for arthritis
  item:
    link id:
      v: mae1.2
    text:
      v: IRB Protocol Number
    answer:
      value:
        v: PRO098765
  item:
    link id:
      v: mae1.3
    text:
      v: Study Type
    answer:
      value: Coding
  item:
    link id:
      v: mae1.4
    text:
      v: Does this protocol require an FDA exemption?
    answer:
      value: Coding
  item:
    link id:
      v: mae1.5
    text:
      v: Is an IND or IDE being used in this study?
    answer:
      value: Coding
item:
  link id:
    v: mae4
  text:
    v: Organization/Site
  item:
    link id:
      v: mae4.1
    text:
      v: Where Adverse Medical Event Occurred
    item:
      link id:
        v: mae4.1.7
      text:
        v: Did the Adverse Medical Event occur at the lead principal investigator site?
      answer:
        value: Coding
    item:
      link id:
        v: ExternalDataFor_mae4.1.1
      text:
        v: External Data For linkId mae4.1.1
    item:
      link id:
        v: mae4.1.1
      text:
        v: If the Adverse Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the the relying institution and relying site principal investigator details below.
      answer:
        value: Coding
    item:
      link id:
        v: mae4.1.2
      text:
        v: Name of organization/site where the event occurred
  item:
    link id:
      v: mae4.7
    text:
      v: Site Principal Investigator
    item:
      link id:
        v: mae4.7.1
      text:
        v: First Name
    item:
      link id:
        v: mae4.7.2
      text:
        v: Last Name
    item:
      link id:
        v: mae4.7.5
      text:
        v: Suffix
    item:
      link id:
        v: mae4.7.6
      text:
        v: Degree(s)
    item:
      link id:
        v: mae4.7.3
      text:
        v: Phone
    item:
      link id:
        v: mae4.7.4
      text:
        v: Email
  item:
    link id:
      v: mae4.9
    text:
      v: Responsibility for Adverse Medical Event Reporting
    item:
      link id:
        v: mae4.9.1
      text:
        v: If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be recording the Adverse Non-Medical Event?
      answer:
        value: Coding
    item:
      link id:
        v: mae4.9.2
      text:
        v: Name of organization/site which is recording the Adverse Medical event
item:
  link id:
    v: mae3
  text:
    v: Primary Contact
  item:
    link id:
      v: mae3.1
    text:
      v: First Name
    answer:
      value:
        v: Jane
  item:
    link id:
      v: mae3.2
    text:
      v: Last Name
    answer:
      value:
        v: Doe
  item:
    link id:
      v: mae3.3
    text:
      v: Phone
    answer:
      value:
        v: 567-123-1234
  item:
    link id:
      v: mae3.4
    text:
      v: Email
item:
  link id:
    v: mae5
  text:
    v: Participant Information
  item:
    link id:
      v: mae5.1
    text:
      v: Patient ID
    answer:
      value:
        v: 12345

v: INT

v: Interventional

v: Y

v: Yes

v: Y

v: Yes

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

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

v: Test Example University

v: Xi-Yang

v: Lee

v: Jr.

v: MD, PhD

v: 6781233456

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

v: Sample University Medical Center

link id:
  v: mae5.2
text:
  v: Age
answer:
  value:
    v: 58

link id:
  v: mae5.3
text:
  v: Birth Sex
answer:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0001
    code:
      v: M
    display:
      v: Male

link id:
  v: mae5.4
text:
  v: Weight
answer:
  value: Quantity
    value:
      v: 245
    unit:
      v: [lb]

link id:
  v: mae5.5
text:
  v: Height
answer:
  value: Quantity
    value:
      v: 67
    unit:
      v: [in]

link id:
  v: mae5.6
text:
  v: Ethnicity
answer:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v3-Ethnicity
    code:
      v: 2186-5
    display:
      v: Not Hispanic or Latino

link id:
  v: mae5.7
text:
  v: Race
answer:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v3-Race
    code:
      v: 2106-3
    display:
      v: White

link id:
  v: mae5.8
text:
  v: Which Arm/Cohort/treatment group was the participant assigned to (if known)?
answer:
  value:
    v: unknown

link id:
  v: mae5.9
text:
  v: Participant dosed or received study agent
answer:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: NI
    display:
      v: No Information

link id:
  v: mae5.11
text:
  v: Were there any Protocol Deviations/Violations/Exceptions for this participant?
answer:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No

link id:
  v: mae6
text:
  v: Adverse Medical Event Information
item:
  link id:
    v: mae6.1
  text:
    v: Submission Type
  answer:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: INITIAL
      display:
        v: Initial
item:
  link id:
    v: mae6.2
  text:
    v: Start Date
  answer:
    value:
      v: 2021-11-05
item:
  link id:
    v: mae6.3
  text:
    v: Reported Date
  answer:
    value:
      v: 2021-11-06
item:
  link id:
    v: mae6.4
  text:
    v: Recorded Date
  answer:
    value:
      v: 2021-11-06
item:
  link id:
    v: mae6.10
  text:
    v: Is the Adverse Medical Event Serious?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/adverse-event-seriousness
      code:
        v: serious
      display:
        v: Serious
item:
  link id:
    v: mae6.9
  text:
    v: Severity
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/adverse-event-severity
      code:
        v: mild
      display:
        v: Mild
item:
  link id:
    v: mae6.40
  text:
    v: Narrative of the Adverse Event:
  answer:
    value:
      v: Blood clot developed in right leg after several days of inactivity. Participant experienced swelling and pain.
item:
  link id:
    v: mae6.5
  text:
    v: Medical Description of Adverse Event
  answer:
    value:
      v: Deep Vein Thrombosis
item:
  link id:
    v: mae6.6
  text:
    v: Is the Adverse Medical event still ongoing?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: mae6.7
  text:
    v: Stop Date
  answer:
    value:
      v: 2021-11-05
item:
  link id:
    v: mae6.8
  text:
    v: Was the event expected?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0239
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: mae6.11
  text:
    v: Seriousness
  item:
    link id:
      v: mae6.11.1
    text:
      v: Seriousness
    answer:
      value: Coding
item:
  link id:
    v: mae6.12
  text:
    v: What is the date Adverse Medical Event became serious?
  answer:
    value:
      v: 2021-11-05
item:
  link id:
    v: mae6.13
  text:
    v: Outcome of Adverse Medical Event
  answer:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: RCVRED
      display:
        v: recovered/resolved
item:
  link id:
    v: mae6.15
  text:
    v: Relationship of Adverse Medical Event to Study Intervention
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess
      code:
        v: possible
      display:
        v: Possible
item:
  link id:
    v: mae6.16
  text:
    v: Rationale for relationship with study intervention
  answer:
    value:
      v: Patient was inactive for several days which might have been the cause.
item:
  link id:
    v: mae6.23
  text:
    v: Action Taken
  item:
    link id:
      v: mae6.23.1
    text:
      v: Action Taken Regarding Study Intervention
    answer:
      value: Coding
item:
  link id:
    v: mae6.24
  text:
    v: If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: mae6.25
  text:
    v: If study intervention was restarted (rechallenge) did AE recur?

v: ResultsInHospitalization

v: Requires or prolongs inpatient hospitalization

v: WT

v: Product withdrawn temporarily

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

link id:
  v: mae6.50
text:
  v: SAE Concomitant Medications, Treatments/Procedures and Tests
item:
  link id:
    v: mae6.50.26
  text:
    v: Did the participant receive any relevant concomitant medications in response to the SAE?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: mae6.50.28
  text:
    v: SAE Concomitant Medications
  item:
    link id:
      v: mae6.50.28.1
    text:
      v: Medication Name
    answer:
      value:
        v: warfarin
  item:
    link id:
      v: mae6.50.28.2
    text:
      v: Indication
    answer:
      value:
        v: anticoagulant
  item:
    link id:
      v: mae6.50.28.3
    text:
      v: Start Date
    answer:
      value:
        v: 2021-11-05
  item:
    link id:
      v: mae6.50.28.4
    text:
      v: Stop Date
    answer:
      value:
        v: 2022-02-04
  item:
    link id:
      v: mae6.50.28.5
    text:
      v: Ongoing
    answer:
      value: Coding
item:
  link id:
    v: mae6.50.29
  text:
    v: Did the participant receive any treatments/procedures in response to the SAE?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: mae6.50.37
  text:
    v: Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: mae6.50.38
  text:
    v: SAE Laboratory or Diagnostic Tests
  item:
    link id:
      v: mae6.50.38.1
    text:
      v: Lab/Diagnostic Test
    answer:
      value:
        v: ultrasound
  item:
    link id:
      v: mae6.50.38.2
    text:
      v: Date
    answer:
      value:
        v: 2021-11-05
  item:
    link id:
      v: mae6.50.38.3
    text:
      v: Result
    answer:
      value:
        v: positive
  item:
    link id:
      v: mae6.50.38.6
    text:
      v: Comments
    answer:
      value:
        v: blood clot noted

v: N

v: No

link id:
  v: mae11
text:
  v: Optional Attachments
item:
  link id:
    v: mae11.1
  text:
    v: Describe the file that is being attached (optional)
  answer:
    value:
      v: Treatment instructions received from sponsor regarding this AE.
item:
  link id:
    v: mae11.2
  text:
    v: Attachment
  answer:
    value: Attachment
      url:
        v: http://example.org/NationalGovernmentFunder/AE/NationalGovernmentFunderInstructions.pdf
      title:
        v: NationalGovernmentFunderInstructions.pdf

link id:
  v: ADMIN00
text:
  v: Administrative Use Only
item:
  link id:
    v: ADMIN01
  text:
    v: Link ID prefix
  answer:
    value:
      v: mae
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