FHIR IG analytics| Package | hl7.fhir.us.sirb |
| Resource Type | QuestionnaireResponse |
| Id | QuestionnaireResponse-medical-ae-populate-exampleQR.json |
| FHIR Version | R4 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
| LinkId | Text | Definition | Answer |
|---|---|---|---|
  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 | 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 | 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 | Race 2106-3: White | |
| mae5.8 | Which Arm/Cohort/treatment group was the participant assigned to (if known)? | unknown | |
| mae5.9 | Participant dosed or received study agent | expandedYes-NoIndicator NI: No Information | |
| mae5.11 | Were there any Protocol Deviations/Violations/Exceptions for this participant? | expandedYes-NoIndicator N: No | |
| mae6 | Adverse Medical Event Information | ||
| mae6.1 | Submission Type | Temporary Codes INITIAL: Initial | |
| mae6.2 | Start Date | 2021-11-05 | |
| mae6.3 | Reported Date | 2021-11-06 | |
| mae6.4 | Recorded Date | 2021-11-06 | |
| mae6.10 | Is the Adverse Medical Event Serious? | AdverseEventSeriousness serious: Serious | |
| mae6.9 | Severity | AdverseEventSeverity mild: Mild | |
| mae6.40 | Narrative of the Adverse Event: | Blood clot developed in right leg after several days of inactivity. Participant experienced swelling and pain. | |
| mae6.5 | Medical Description of Adverse Event | Deep Vein Thrombosis | |
| mae6.6 | Is the Adverse Medical event still ongoing? | expandedYes-NoIndicator N: No | |
| mae6.7 | Stop Date | 2021-11-05 | |
| mae6.8 | Was the event expected? | eventExpected N: No | |
| mae6.11 | Seriousness | ||
| mae6.11.1 | Seriousness | Temporary Codes ResultsInHospitalization: Requires or prolongs inpatient hospitalization | |
| mae6.12 | What is the date Adverse Medical Event became serious? | 2021-11-05 | |
| mae6.13 | Outcome of Adverse Medical Event | Temporary Codes RCVRED: recovered/resolved | |
| mae6.15 | Relationship of Adverse Medical Event to Study Intervention | AdverseEventCausalityAssessment possible: Possible | |
| mae6.16 | Rationale for relationship with study intervention | Patient was inactive for several days which might have been the cause. | |
| mae6.23 | Action Taken | ||
| mae6.23.1 | Action Taken Regarding Study Intervention | actionTakenInResponseToTheEvent WT: Product withdrawn temporarily | |
| mae6.24 | If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate? | expandedYes-NoIndicator Y: Yes | |
| mae6.25 | If study intervention was restarted (rechallenge) did AE recur? | expandedYes-NoIndicator N: No | |
| mae6.50 | SAE Concomitant Medications, Treatments/Procedures and Tests | ||
| mae6.50.26 | Did the participant receive any relevant concomitant medications in response to the SAE? | expandedYes-NoIndicator Y: Yes | |
| mae6.50.28 | SAE Concomitant Medications | ||
| mae6.50.28.1 | Medication Name | warfarin | |
| mae6.50.28.2 | Indication | anticoagulant | |
| mae6.50.28.3 | Start Date | 2021-11-05 | |
| mae6.50.28.4 | Stop Date | 2022-02-04 | |
| mae6.50.28.5 | Ongoing | expandedYes-NoIndicator N: No | |
| mae6.50.29 | Did the participant receive any treatments/procedures in response to the SAE? | expandedYes-NoIndicator N: No | |
| mae6.50.37 | Did the participant receive relevant laboratory or diagnostic tests in response to the SAE? | expandedYes-NoIndicator Y: Yes | |
| mae6.50.38 | SAE Laboratory or Diagnostic Tests | ||
| mae6.50.38.1 | Lab/Diagnostic Test | ultrasound | |
| mae6.50.38.2 | Date | 2021-11-05 | |
| mae6.50.38.3 | Result | positive | |
| mae6.50.38.6 | Comments | blood clot noted | |
| mae11 | Optional Attachments | ||
| mae11.1 | Describe the file that is being attached (optional) | Treatment instructions received from sponsor regarding this AE. | |
| mae11.2 | Attachment | No display for Attachment | |
| ADMIN00 | Administrative Use Only | ||
| ADMIN01 | Link ID prefix | mae | |
| 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 | |||
FHIR
FHIRsmith{
"resourceType": "QuestionnaireResponse",
"id": "medical-ae-populate-exampleQR",
"meta": {
"versionId": "1",
"lastUpdated": "2022-03-12T01:53:26.773+00:00"
},
"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/workflow-researchStudy",
"valueReference": {
"reference": "ResearchStudy/ResearchStudyExample-sIRB",
"display": "ResearchStudyExample-sIRB"
}
}
],
"questionnaire": "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate",
"status": "completed",
"authored": "2022-03-12T01:53:25.336Z",
"item": [
{
"linkId": "mae1",
"text": "Research Study",
"item": [
{
"linkId": "mae1.1",
"text": "Study Title",
"answer": [
{
"valueString": "Study of Drug A for arthritis"
}
]
},
{
"linkId": "mae1.2",
"text": "IRB Protocol Number",
"answer": [
{
"valueString": "PRO098765"
}
]
},
{
"linkId": "mae1.3",
"text": "Study Type",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "INT",
"display": "Interventional"
}
}
]
},
{
"linkId": "mae1.4",
"text": "Does this protocol require an FDA exemption?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "mae1.5",
"text": "Is an IND or IDE being used in this study?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
}
]
},
{
"linkId": "mae4",
"text": "Organization/Site",
"item": [
{
"linkId": "mae4.1",
"text": "Where Adverse Medical Event Occurred",
"item": [
{
"linkId": "mae4.1.7",
"text": "Did the Adverse Medical Event occur at the lead principal investigator site?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "N",
"display": "No"
}
}
]
},
{
"linkId": "ExternalDataFor_mae4.1.1",
"text": "External Data For linkId mae4.1.1",
"answer": [
{
"valueString": "Sample University Medical Center | | Jane Doe, MD | Sample City, NC"
},
{
"valueString": "Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA"
},
{
"valueString": "Central Campus Test University | | Maria Smith, PhD | Central, MI"
}
]
},
{
"linkId": "mae4.1.1",
"text": "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": [
{
"valueCoding": {
"display": "Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA"
}
}
]
},
{
"linkId": "mae4.1.2",
"text": "Name of organization/site where the event occurred",
"answer": [
{
"valueString": "Test Example University"
}
]
}
]
},
{
"linkId": "mae4.7",
"text": "Site Principal Investigator",
"item": [
{
"linkId": "mae4.7.1",
"text": "First Name",
"answer": [
{
"valueString": "Xi-Yang"
}
]
},
{
"linkId": "mae4.7.2",
"text": "Last Name",
"answer": [
{
"valueString": "Lee"
}
]
},
{
"linkId": "mae4.7.5",
"text": "Suffix",
"answer": [
{
"valueString": "Jr."
}
]
},
{
"linkId": "mae4.7.6",
"text": "Degree(s)",
"answer": [
{
"valueString": "MD, PhD"
}
]
},
{
"linkId": "mae4.7.3",
"text": "Phone",
"answer": [
{
"valueString": "6781233456"
}
]
},
{
"linkId": "mae4.7.4",
"text": "Email",
"answer": [
{
"valueString": "XiYangLee@teu.med.edu"
}
]
}
]
},
{
"linkId": "mae4.9",
"text": "Responsibility for Adverse Medical Event Reporting",
"item": [
{
"linkId": "mae4.9.1",
"text": "If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be recording the Adverse Non-Medical Event?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "mae4.9.2",
"text": "Name of organization/site which is recording the Adverse Medical event",
"answer": [
{
"valueString": "Sample University Medical Center"
}
]
}
]
}
]
},
{
"linkId": "mae3",
"text": "Primary Contact",
"item": [
{
"linkId": "mae3.1",
"text": "First Name",
"answer": [
{
"valueString": "Jane"
}
]
},
{
"linkId": "mae3.2",
"text": "Last Name",
"answer": [
{
"valueString": "Doe"
}
]
},
{
"linkId": "mae3.3",
"text": "Phone",
"answer": [
{
"valueString": "567-123-1234"
}
]
},
{
"linkId": "mae3.4",
"text": "Email",
"answer": [
{
"valueString": "drjanedoe@sampleuniversity.edu"
}
]
}
]
},
{
"linkId": "mae5",
"text": "Participant Information",
"item": [
{
"linkId": "mae5.1",
"text": "Patient ID",
"answer": [
{
"valueString": "12345"
}
]
},
{
"linkId": "mae5.2",
"text": "Age",
"answer": [
{
"valueString": "58"
}
]
},
{
"linkId": "mae5.3",
"text": "Birth Sex",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0001",
"code": "M",
"display": "Male"
}
}
]
},
{
"linkId": "mae5.4",
"text": "Weight",
"answer": [
{
"valueQuantity": {
"value": 245,
"unit": "[lb]"
}
}
]
},
{
"linkId": "mae5.5",
"text": "Height",
"answer": [
{
"valueQuantity": {
"value": 67,
"unit": "[in]"
}
}
]
},
{
"linkId": "mae5.6",
"text": "Ethnicity",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v3-Ethnicity",
"code": "2186-5",
"display": "Not Hispanic or Latino"
}
}
]
},
{
"linkId": "mae5.7",
"text": "Race",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v3-Race",
"code": "2106-3",
"display": "White"
}
}
]
},
{
"linkId": "mae5.8",
"text": "Which Arm/Cohort/treatment group was the participant assigned to (if known)?",
"answer": [
{
"valueString": "unknown"
}
]
},
{
"linkId": "mae5.9",
"text": "Participant dosed or received study agent",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "NI",
"display": "No Information"
}
}
]
},
{
"linkId": "mae5.11",
"text": "Were there any Protocol Deviations/Violations/Exceptions for this participant?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "N",
"display": "No"
}
}
]
}
]
},
{
"linkId": "mae6",
"text": "Adverse Medical Event Information",
"item": [
{
"linkId": "mae6.1",
"text": "Submission Type",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "INITIAL",
"display": "Initial"
}
}
]
},
{
"linkId": "mae6.2",
"text": "Start Date",
"answer": [
{
"valueDate": "2021-11-05"
}
]
},
{
"linkId": "mae6.3",
"text": "Reported Date",
"answer": [
{
"valueDate": "2021-11-06"
}
]
},
{
"linkId": "mae6.4",
"text": "Recorded Date",
"answer": [
{
"valueDate": "2021-11-06"
}
]
},
{
"linkId": "mae6.10",
"text": "Is the Adverse Medical Event Serious?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
"code": "serious",
"display": "Serious"
}
}
]
},
{
"linkId": "mae6.9",
"text": "Severity",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
"code": "mild",
"display": "Mild"
}
}
]
},
{
"linkId": "mae6.40",
"text": "Narrative of the Adverse Event:",
"answer": [
{
"valueString": "Blood clot developed in right leg after several days of inactivity. Participant experienced swelling and pain."
}
]
},
{
"linkId": "mae6.5",
"text": "Medical Description of Adverse Event",
"answer": [
{
"valueString": "Deep Vein Thrombosis"
}
]
},
{
"linkId": "mae6.6",
"text": "Is the Adverse Medical event still ongoing?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "N",
"display": "No"
}
}
]
},
{
"linkId": "mae6.7",
"text": "Stop Date",
"answer": [
{
"valueDate": "2021-11-05"
}
]
},
{
"linkId": "mae6.8",
"text": "Was the event expected?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0239",
"code": "N",
"display": "No"
}
}
]
},
{
"linkId": "mae6.11",
"text": "Seriousness",
"item": [
{
"linkId": "mae6.11.1",
"text": "Seriousness",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "ResultsInHospitalization",
"display": "Requires or prolongs inpatient hospitalization"
}
}
]
}
]
},
{
"linkId": "mae6.12",
"text": "What is the date Adverse Medical Event became serious?",
"answer": [
{
"valueDate": "2021-11-05"
}
]
},
{
"linkId": "mae6.13",
"text": "Outcome of Adverse Medical Event",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "RCVRED",
"display": "recovered/resolved"
}
}
]
},
{
"linkId": "mae6.15",
"text": "Relationship of Adverse Medical Event to Study Intervention",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
"code": "possible",
"display": "Possible"
}
}
]
},
{
"linkId": "mae6.16",
"text": "Rationale for relationship with study intervention",
"answer": [
{
"valueString": "Patient was inactive for several days which might have been the cause."
}
]
},
{
"linkId": "mae6.23",
"text": "Action Taken",
"item": [
{
"linkId": "mae6.23.1",
"text": "Action Taken Regarding Study Intervention",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0251",
"code": "WT",
"display": "Product withdrawn temporarily"
}
}
]
}
]
},
{
"linkId": "mae6.24",
"text": "If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "mae6.25",
"text": "If study intervention was restarted (rechallenge) did AE recur?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "N",
"display": "No"
}
}
]
},
{
"linkId": "mae6.50",
"text": "SAE Concomitant Medications, Treatments/Procedures and Tests",
"item": [
{
"linkId": "mae6.50.26",
"text": "Did the participant receive any relevant concomitant medications in response to the SAE?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "mae6.50.28",
"text": "SAE Concomitant Medications",
"item": [
{
"linkId": "mae6.50.28.1",
"text": "Medication Name",
"answer": [
{
"valueString": "warfarin"
}
]
},
{
"linkId": "mae6.50.28.2",
"text": "Indication",
"answer": [
{
"valueString": "anticoagulant"
}
]
},
{
"linkId": "mae6.50.28.3",
"text": "Start Date",
"answer": [
{
"valueDate": "2021-11-05"
}
]
},
{
"linkId": "mae6.50.28.4",
"text": "Stop Date",
"answer": [
{
"valueDate": "2022-02-04"
}
]
},
{
"linkId": "mae6.50.28.5",
"text": "Ongoing",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "N",
"display": "No"
}
}
]
}
]
},
{
"linkId": "mae6.50.29",
"text": "Did the participant receive any treatments/procedures in response to the SAE?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "N",
"display": "No"
}
}
]
},
{
"linkId": "mae6.50.37",
"text": "Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "mae6.50.38",
"text": "SAE Laboratory or Diagnostic Tests",
"item": [
{
"linkId": "mae6.50.38.1",
"text": "Lab/Diagnostic Test",
"answer": [
{
"valueString": "ultrasound"
}
]
},
{
"linkId": "mae6.50.38.2",
"text": "Date",
"answer": [
{
"valueDate": "2021-11-05"
}
]
},
{
"linkId": "mae6.50.38.3",
"text": "Result",
"answer": [
{
"valueString": "positive"
}
]
},
{
"linkId": "mae6.50.38.6",
"text": "Comments",
"answer": [
{
"valueString": "blood clot noted"
}
]
}
]
}
]
}
]
},
{
"linkId": "mae11",
"text": "Optional Attachments",
"item": [
{
"linkId": "mae11.1",
"text": "Describe the file that is being attached (optional)",
"answer": [
{
"valueString": "Treatment instructions received from sponsor regarding this AE."
}
]
},
{
"linkId": "mae11.2",
"text": "Attachment",
"answer": [
{
"valueAttachment": {
"url": "http://example.org/NationalGovernmentFunder/AE/NationalGovernmentFunderInstructions.pdf",
"title": "NationalGovernmentFunderInstructions.pdf"
}
}
]
}
]
},
{
"linkId": "ADMIN00",
"text": "Administrative Use Only",
"item": [
{
"linkId": "ADMIN01",
"text": "Link ID prefix",
"answer": [
{
"valueString": "mae"
}
]
},
{
"linkId": "ADMIN02",
"text": "Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any",
"answer": [
{
"valueString": "initiate-study-populate-exampleQR"
}
]
},
{
"linkId": "ADMIN03",
"text": "ID of the Research Study FHIR Resource associated with the study Questionnaire Responses",
"answer": [
{
"valueString": "ResearchStudyExample-sIRB"
}
]
}
]
}
]
}