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FHIR IG Statistics: Questionnaire/sirb-adverse-event-questionnaire-populate

Packagehl7.fhir.us.sirb
Resource TypeQuestionnaire
Idsirb-adverse-event-questionnaire-populate
FHIR VersionR4
Sourcehttp://hl7.org/fhir/us/sirb/https://build.fhir.org/ig/HL7/fhir-sirb/Questionnaire-sirb-adverse-event-questionnaire-populate.html
URLhttp://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate
Version1.0.0
Statusdraft
Date2023-04-24T20:03:27+00:00
NameAE_Questionnaire
TitleAdverse Medical Event Questionnaire
Realmus
Authorityhl7

Resources that use this resource

No resources found

Resources that this resource uses

No resources found

Narrative

Note: links and images are rebased to the (stated) source

Structure
LinkIdTextCardinalityTypeFlagsDescription & Constraintsdoco
.. AE_QuestionnaireQuestionnairehttp://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate#1.0.0
... mae1Research Study0..1group
.... mae1.1Study Title0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value
..... mae1.1_helpShort title of the study, the same title listed on the Informed Consent0..1display
.... mae1.2IRB Protocol Number0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value
..... mae1.2_helpNumber assigned by IRB; this number is the same as that on the Consent Form0..1display
.... mae1.3Study Type0..1choiceOptions: 2 options
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.4').answer.valueCoding
..... mae1.3_helpSelect the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)0..1display
.... mae1.4Does this protocol require an FDA exemption?0..1choiceOptions: 2 options
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.1').answer.valueCoding
..... mae1.4_helpIndicator for use of FDA regulated product0..1display
.... mae1.5Is an IND or IDE being used in this study?0..1choiceOptions: 2 options
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.2').answer.valueCoding
..... mae1.5_helpIs an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?0..1display
.... mae1.6Select whether Investigational New Drug (IND) or Investigational Device Exemption (IDE):0..1choiceEnable When: mae1.5 = Yes (expandedYes-NoIndicator#Y)
Options: 2 options
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.4').answer.valueCoding
.... mae1.7IND/IDE Number0..1stringEnable When: mae1.5 = Yes (expandedYes-NoIndicator#Y)
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value
... mae4Organization/Site0..1group
.... mae4.1Where Adverse Medical Event Occurred0..1group
..... mae4.1.7Did the Adverse Medical Event occur at the lead principal investigator site?1..1choiceOptions: 2 options
...... mae4.1.7_helpThis question and its answer will not print on the Adverse Medical Event Form but are necessary for the form logic. Select "Yes" if the Adverse Medical Event occurred at the lead principal investigator site, the study coordinating center or other administrative unit for the overall study.0..1display
..... ExternalDataFor_mae4.1.1External Data For linkId mae4.1.10..*open-choiceiconExpressions:
  • Initial Value: %lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value
..... mae4.1.1If 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.0..1choiceEnable When: mae4.1.7 = No (expandedYes-NoIndicator#N)
...... mae4.1.1_helpThis question and its answer will not print on the Adverse Medical Event Form but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details.0..1display
..... mae4.1.2Name of organization/site where the event occurred0..1stringEnable When: mae4.1.7 exists true
Expressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value)
..... mae4.1_helpLocation where Adverse Medical Event occurred. Adverse Medical Event is any untoward medical occurrence associated with a participant in research, whether or not associated with the participant's activities in the research.0..1display
.... mae4.7Site Principal Investigator0..1groupEnable When: mae4.1.7 exists true
..... mae4.7.1First Name0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value)
...... mae4.7.1_helpFirst or given name of the principal investigator at site where Adverse Medical Event occurred0..1display
..... mae4.7.2Last Name0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value)
...... mae4.7.2_helpSurname or family name0..1display
..... mae4.7.5Suffix0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value)
...... mae4.7.5_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.0..1display
..... mae4.7.6Degree(s)0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value)
...... mae4.7.6_helpProfessional and Academic degrees of the principal investigator at site where Adverse Medical Event occurred0..1display
..... mae4.7.3Phone0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value)
...... mae4.7.3_help10-digit phone number, including area code0..1display
..... mae4.7.4Email0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value)
..... mae4.7_helpPrincipal Investigator at site where Adverse Medical Event occurred0..1display
.... mae4.9Responsibility for Adverse Medical Event Reporting0..1groupEnable When: mae4.1.7 exists true
..... mae4.9.1If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be recording the Adverse Non-Medical Event?1..1choiceEnable When: mae4.1.7 = No (expandedYes-NoIndicator#N)
Options: 2 options
...... mae4.9.1_helpSelect "Yes" if the Adverse Medical Event is being recorded by the lead principal investigator site, the study coordinating center or other administrative unit for the overall study.0..1display
..... mae4.9.2Name of organization/site which is recording the Adverse Medical event0..1stringEnable When:
Expressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y' or %relyingSiteEventReportedByLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, iif(%relyingSiteEventReportedByLeadPISite = 'N', %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value) )
...... mae4.9.2_helpLocation where adverse event is recorded0..1display
... mae3Primary Contact0..1group
.... mae3_helpPersonnel completing the adverse medical event documentation at the lead or relying site0..1display
.... mae3.1First Name0..1string
..... mae3.1_helpFirst or given name0..1display
.... mae3.2Last Name0..1string
..... mae3.2_helpSurname or family name0..1display
.... mae3.3Phone0..1string
..... mae3.3_help10-digit phone number, including area code0..1display
.... mae3.4Email0..1string
... mae5Participant Information0..1group
.... mae5.1Patient ID0..1string
..... mae5.1_helpParticipant identifier from study case report form0..1display
.... mae5.2Age0..1string
.... mae5.3Birth Sex0..1choiceOptions: 4 options
.... mae5.4Weight0..1quantity
..... mae5.4_helpSelect pounds or kilograms0..1display
.... mae5.5Height0..1quantity
..... mae5.5_helpSelect inches, feet, centimeters, meters0..1display
.... mae5.6Ethnicity0..1choiceOptions: 2 options
.... mae5.7Race0..*choiceiconOptions: 5 options
.... mae5.8Which Arm/Cohort/treatment group was the participant assigned to (if known)?0..1string
..... mae5.8_helpPatient's treatment strategy assignment, if known.0..1display
.... mae5.9Participant dosed or received study agent0..1choiceOptions: 4 options
..... mae5.9_helpDid the participant receive the investigational agent? If answer is unknown due to blinding, select No Information.0..1display
.... mae5.10What study agent was received:0..1choiceEnable When:
  • mae5.9 = Yes (expandedYes-NoIndicator#Y)
  • mae5.9 = No Information (expandedYes-NoIndicator#NI)

Options: 3 options
..... mae5.10_helpinvestigational agent or placebo or blinded study0..1display
.... mae5.11Were there any Protocol Deviations/Violations/Exceptions for this participant?0..1choiceOptions: 2 options
..... mae5.11_helpIndicator if adverse medical event occurred with protocol deviation, violation, exception0..1display
.... mae5.12Describe the Protocol Deviations/Violations/Exceptions0..1textEnable When: mae5.11 = Yes (expandedYes-NoIndicator#Y)
..... mae5.12_helpDescription of protocol deviations, violations, or exceptions that occurred for this participant0..1display
... mae6Adverse Medical Event Information0..1group
.... mae6.1Submission Type0..1choiceOptions: 2 options
..... mae6.1_helpInitial: the first time that the adverse medical event is reported or Update: update on a previously reported adverse medical event0..1display
.... mae6.2Start Date0..1date
..... mae6.2_helpDate adverse event started0..1display
.... mae6.3Reported Date0..1date
..... mae6.3_helpDate of this report0..1display
.... mae6.4Recorded Date0..1date
..... mae6.4_helpDate this adverse event was first recorded0..1display
.... mae6.10Is the Adverse Medical Event Serious?0..1choiceOptions: 2 options
..... mae6.10_helpEvent is considered serious and reportable to the FDA in the following outcomes: death, life-threatening, hospitalization, disability or permanent damage, congenital anaomaly/birth defect, need for required intervention to prevent permanent impairment or damage. See FDA Guidance: https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event0..1display
.... mae6.9Severity0..1choiceOptions: 3 options
..... mae6.9_helpPhysician assessment using sponsor defined categories0..1display
.... mae6.40Narrative of the Adverse Event:0..1textEnable When: mae6.10 = Serious (AdverseEventSeriousness#serious)
..... mae6.40_helpDescription of the SAE including chronological clinical presentation and evolution of the SAE and associated signs/symptoms. Serious Medical Event criteria are defined in the protocol.0..1display
.... mae6.5Medical Description of Adverse Event0..1text
..... mae6.5_helpDiagnosis associated with adverse event. Any untoward medical occurrence associated with the use of a drug or device, whether or not considered related to the drug or device.0..1display
.... mae6.6Is the Adverse Medical event still ongoing?0..1choiceOptions: 2 options
..... mae6.6_helpIndicator if the adverse event is still continuing or has been resolved.0..1display
.... mae6.7Stop Date0..1dateEnable When: mae6.6 = No (expandedYes-NoIndicator#N)
..... mae6.7_helpDate that the event resolved0..1display
.... mae6.8Was the event expected?0..1choiceOptions: 2 options
..... mae6.8_helpIndicator that Adverse Medical Event was expected or not expected.0..1display
.... mae6.11Seriousness0..1groupEnable When: mae6.10 = Serious (AdverseEventSeriousness#serious)
..... mae6.11.1Seriousness0..1choiceEnable When: mae6.10 = Serious (AdverseEventSeriousness#serious)
Options: 7 options
...... mae6.11.1_helpAn adverse event is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. DFR Title 21, Part 312, Subpart B, Sec. 312.320..1display
..... mae6.11.2Other-specify0..1textEnable When: mae6.11.1 = Other (Temporary Codes#Other)
...... mae6.11.2_helpDescribe other serious consequences or other medically important condition0..1display
.... mae6.12What is the date Adverse Medical Event became serious?0..1dateEnable When: mae6.10 = Serious (AdverseEventSeriousness#serious)
..... mae6.12_helpDate adverse event was deemed as serious0..1display
.... mae6.13Outcome of Adverse Medical Event0..1choiceOptions: 6 options
..... mae6.13_helpParticipant's status after the adverse event0..1display
.... mae6.14Was autopsy performed?0..1choiceEnable When: mae6.13 = Fatal (Temporary Codes#FATAL)
Options: 3 options
..... mae6.14_helpIndicator if participant was autopsied0..1display
.... mae6.15Relationship of Adverse Medical Event to Study Intervention0..1choiceOptions: 6 options
.... mae6.16Rationale for relationship with study intervention0..1text
..... mae6.16_helpExplanation for relationship between study intervention and adverse event. You may also discuss why the AE appears to be unrelated or why it is not possible to determine the relationship.0..1display
.... mae6.17If applicable, what are possible alternate causes of the Adverse Medical Event?0..1choiceOptions: 6 options
..... mae6.17_helpReason for possible alternative serious adverse event causes0..1display
.... mae6.18Study Procedure-specify0..1textEnable When: mae6.17 = Study Procedure (Temporary Codes#STDYPRO)
..... mae6.18_helpStudy procedure associated with SAE0..1display
.... mae6.19Pre-existing condition-specify0..1textEnable When: mae6.17 = Pre-existing condition (Temporary Codes#PRE)
..... mae6.19_helpPre-existing condition associated with SAE0..1display
.... mae6.20Underlying disease-specify0..1textEnable When: mae6.17 = Underlying disease (Temporary Codes#UNDERLYINGDIS)
..... mae6.20_helpUnderlying disease associated with SAE0..1display
.... mae6.21Concomittant medication-specify0..1textEnable When: mae6.17 = Concomitant medication (Temporary Codes#CONCMITMED)
..... mae6.21_helpConcomitant medication associated with SAE0..1display
.... mae6.22Other known or suspected cause-specify0..1textEnable When: mae6.17 = Other known or suspected cause (Temporary Codes#OTHERCAUSE)
..... mae6.22_helpDescription of other causal reason associated with SAE0..1display
.... mae6.23Action Taken0..1group
..... mae6.23.1Action Taken Regarding Study Intervention0..1choiceOptions: 7 options
...... mae6.23.1_helpChanges to study intervention made after adverse event was detected0..1display
.... mae6.24If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate?0..1choiceOptions: 3 options
..... mae6.24_helpAdverse event diminished/abated after study intervention was discontinued, interrupted, or dose reduced (dechallenged)0..1display
.... mae6.25If study intervention was restarted (rechallenge) did AE recur?0..1choiceOptions: 3 options
..... mae6.25_helpAdverse event recurred when the study intervention was restarted0..1display
.... mae6.50SAE Concomitant Medications, Treatments/Procedures and Tests0..1groupEnable When: mae6.10 = Serious (AdverseEventSeriousness#serious)
..... mae6.50.26Did the participant receive any relevant concomitant medications in response to the SAE?0..1choiceEnable When: mae6.10 = Serious (AdverseEventSeriousness#serious)
Options: 2 options
..... mae6.50.28SAE Concomitant Medications0..*groupEnable When: mae6.50.26 = Yes (expandedYes-NoIndicator#Y)
...... mae6.50.28.1Medication Name0..1string
....... mae6.50.28.1_helpName of concomitant medication given to participant in response to SAE0..1display
...... mae6.50.28.2Indication0..1string
....... mae6.50.28.2_helpIndication for giving the concomitant medication to participant0..1display
...... mae6.50.28.3Start Date0..1date
....... mae6.50.28.3_helpStart date for the concomitant medication given to participant0..1display
...... mae6.50.28.4Stop Date0..1date
....... mae6.50.28.4_helpStop date for the concomitant medication given to the participant0..1display
...... mae6.50.28.5Ongoing0..1choiceOptions: 2 options
....... mae6.50.28.5_helpIs concomitant medication administration for participant ongoing?0..1display
...... mae6.50.28_helpConcomitant medication associated with SAE0..1display
..... mae6.50.29Did the participant receive any treatments/procedures in response to the SAE?0..1choiceEnable When: mae6.10 = Serious (AdverseEventSeriousness#serious)
Options: 2 options
...... mae6.50.29_helpTreatments/procedures administered in response to SAE0..1display
..... mae6.50.30SAE Treatments/Procedures0..*groupEnable When: mae6.50.29 = Yes (expandedYes-NoIndicator#Y)
...... mae6.50.30.1Treatment/Procedure0..1string
....... mae6.50.30.1_helpName of SAE treatment/procedure participant received0..1display
...... mae6.50.30.2Start Date0..1date
....... mae6.50.30.2_helpStart date for SAE treatment/procedure participant received0..1display
...... mae6.50.30.3Stop Date0..1date
....... mae6.50.30.3_helpStop date for SAE treatment/procedure participant received0..1display
...... mae6.50.30.4Ongoing0..1choiceOptions: 2 options
....... mae6.50.30.4_helpIs the SAE treatment/procedure for the participant ongoing0..1display
...... mae6.50.30_helpSAE treatment/procedure participant received0..1display
..... mae6.50.37Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?0..1choiceEnable When: mae6.10 = Serious (AdverseEventSeriousness#serious)
Options: 2 options
...... mae6.50.37_helpWere any laboratory or diagnostic tests administered to the participant in response to the SAE?0..1display
..... mae6.50.38SAE Laboratory or Diagnostic Tests0..*groupEnable When: mae6.50.37 = Yes (expandedYes-NoIndicator#Y)
...... mae6.50.38.1Lab/Diagnostic Test0..1string
...... mae6.50.38.2Date0..1date
...... mae6.50.38.3Result0..1string
...... mae6.50.38.4Low Range0..1string
...... mae6.50.38.5High Range0..1string
...... mae6.50.38.6Comments0..1string
...... mae6.50.38_helpLaboratory or diagnostic tests obtained in response to SAE0..1display
.... mae6_helpAn event that (1) is more likely than not related to study activities; and (2) represents a new risk; and (3) is unanticipated. In addition, an expected event that is occurring at a frequency or intensity greater than originally anticipated.0..1display
... mae11Optional Attachments0..*group
.... mae11.1Describe the file that is being attached (optional)0..1string
.... mae11.2Attachment0..1attachment
.... mae11_helpAttachments related to the Adverse Event Report can be included here.0..1display
... ADMIN00Administrative Use Only0..1groupicon
.... ADMIN01Link ID prefix0..1stringiconInitial Value: string = mae
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any0..1stringiconInitial Value: string = temporarily unavailable
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire Responses0..1stringiconInitial Value: string = temporarily unavailable
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value
.... ADMIN04Questionnaire Response ID of the local considerations Questionnaire Response, if any0..1stringicon

doco Documentation for this format

Option Sets

Answer options for mae1.3

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#INT ("Interventional")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#OBS ("Observational")

Answer options for mae1.4

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for mae1.5

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for mae1.6

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IND ("IND")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IDE ("IDE")

Answer options for mae4.1.7

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for mae4.9.1

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for mae5.3

  • http://terminology.hl7.org/CodeSystem/v2-0001#F ("Female")
  • http://terminology.hl7.org/CodeSystem/v2-0001#M ("Male")
  • http://terminology.hl7.org/CodeSystem/v2-0001#O ("Other")
  • http://terminology.hl7.org/CodeSystem/v2-0001#U ("Unknown")

Answer options for mae5.6

  • http://terminology.hl7.org/CodeSystem/v3-Ethnicity#2135-2 ("Hispanic or Latino")
  • http://terminology.hl7.org/CodeSystem/v3-Ethnicity#2186-5 ("Not Hispanic or Latino")

Answer options for mae5.7

  • http://terminology.hl7.org/CodeSystem/v3-Race#2028-9 ("Asian")
  • http://terminology.hl7.org/CodeSystem/v3-Race#1002-5 ("American Indian or Alaska Native")
  • http://terminology.hl7.org/CodeSystem/v3-Race#2054-5 ("Black or African American")
  • http://terminology.hl7.org/CodeSystem/v3-Race#2076-8 ("Native Hawaiian or Other Pacific Islander")
  • http://terminology.hl7.org/CodeSystem/v3-Race#2106-3 ("White")

Answer options for mae5.9

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
  • http://terminology.hl7.org/CodeSystem/v2-0532#NI ("No Information")
  • http://terminology.hl7.org/CodeSystem/v2-0532#NA ("not applicable")

Answer options for mae5.10

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#SA ("Study Agent")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PLACEBO ("Placebo")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#BSA ("Blinded Study Agent")

Answer options for mae5.11

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for mae6.1

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#INITIAL ("Initial")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#UPDATE ("Update")

Answer options for mae6.10

  • http://terminology.hl7.org/CodeSystem/adverse-event-seriousness#serious ("Serious")
  • http://terminology.hl7.org/CodeSystem/adverse-event-seriousness#non-serious ("Non-serious")

Answer options for mae6.9

  • http://terminology.hl7.org/CodeSystem/adverse-event-severity#mild ("Mild")
  • http://terminology.hl7.org/CodeSystem/adverse-event-severity#moderate ("Moderate")
  • http://terminology.hl7.org/CodeSystem/adverse-event-severity#severe ("Severe")

Answer options for mae6.6

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for mae6.8

  • http://terminology.hl7.org/CodeSystem/v2-0239#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0239#N ("No")

Answer options for mae6.11.1

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#ResultsInDeath ("Results in death")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IsLifeThreatening ("Is Life-threatening")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#ResultsInHospitalization ("Requires or prolongs inpatient hospitalization")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IsBirthDefect ("Is a congenital anomaly/birth defect")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#ResultsInDisability ("Results in persistent or significant disability/incapacity")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#RequiresPreventImpairment ("Requires intervention to prevent permanent impairment")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#Other ("Other")

Answer options for mae6.13

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#RCVRED ("recovered/resolved")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#RCVRING ("recovering/resolving")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#NRCVRED ("not recovered/not resolved/ongoing")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#SEQL ("recovered/resolved with sequelae")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#FATAL ("fatal")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#UNK ("unknown")

Answer options for mae6.14

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
  • http://terminology.hl7.org/CodeSystem/v2-0532#UNK ("Unknown")

Answer options for mae6.15

  • http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess#certain ("Certain")
  • http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess#probably-likely ("Probably/Likely")
  • http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess#possible ("Possible")
  • http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess#unlikely ("Unlikely")
  • http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess#conditional-classified ("Conditional/Classified")
  • http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess#unassessable-unclassifiable ("Unassessable/Unclassifiable")

Answer options for mae6.17

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PRMYDIS ("Primary disease")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#STDYPRO ("Study Procedure")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PRE ("Pre-existing condition")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#UNDERLYINGDIS ("Underlying disease")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#CONCMITMED ("Concomitant medication")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#OTHERCAUSE ("Other known or suspected cause")

Answer options for mae6.23.1

  • http://terminology.hl7.org/CodeSystem/v2-0251#WP ("Product withdrawn permanently")
  • http://terminology.hl7.org/CodeSystem/v2-0251#WT ("Product withdrawn temporarily")
  • http://terminology.hl7.org/CodeSystem/v2-0251#DR ("Product dose or frequency of use reduced")
  • http://terminology.hl7.org/CodeSystem/v2-0251#DI ("Product dose or frequency of use increased")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#NC ("Product dose or frequency of use not changed")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#UNK ("Unknown")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#NA ("Not applicable")

Answer options for mae6.24

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
  • http://terminology.hl7.org/CodeSystem/v2-0532#NA ("not applicable")

Answer options for mae6.25

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
  • http://terminology.hl7.org/CodeSystem/v2-0532#NA ("not applicable")

Answer options for mae6.50.26

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for mae6.50.28.5

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for mae6.50.29

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for mae6.50.30.4

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for mae6.50.37

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Source

{
  "resourceType": "Questionnaire",
  "id": "sirb-adverse-event-questionnaire-populate",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "extension": [
        {
          "url": "name",
          "valueCoding": {
            "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
            "code": "sourceQuestionnaireResponse",
            "display": "The content of the Questionnaire Response transferred to this Questionnaire during form launch"
          }
        },
        {
          "url": "type",
          "valueCode": "QuestionnaireResponse"
        },
        {
          "url": "description",
          "valueString": "The Initiate a Study Questionnaire Response content that will be used to pre-populate this Questionnaire"
        }
      ],
      "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-launchContext"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/variable",
      "valueExpression": {
        "description": "variable to store the incoming data from the launchContext extension for populate and other expressions",
        "name": "lookupInitiateStudy",
        "language": "text/fhirpath",
        "expression": "%sourceQuestionnaireResponse"
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/variable",
      "valueExpression": {
        "description": "event happened at the lead PI site/coordinating center",
        "name": "eventOccurredAtLeadPISite",
        "language": "text/fhirpath",
        "expression": "%resource.descendants().where(linkId = 'mae4.1.7').answer.valueCoding.code"
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/variable",
      "valueExpression": {
        "description": "relying site where AE occurred",
        "name": "relyingSiteForForm",
        "language": "text/fhirpath",
        "expression": "%resource.descendants().where(linkId = 'mae4.1.1').answer.value.display"
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/variable",
      "valueExpression": {
        "description": "being reported by lead PI site",
        "name": "relyingSiteEventReportedByLeadPISite",
        "language": "text/fhirpath",
        "expression": "%resource.descendants().where(linkId = 'mae4.9.1').answer.valueCoding.code"
      }
    }
  ],
  "url": "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate",
  "version": "1.0.0",
  "name": "AE_Questionnaire",
  "title": "Adverse Medical Event Questionnaire",
  "status": "draft",
  "subjectType": [
    "ResearchStudy"
  ],
  "date": "2023-04-24T20:03:27+00:00",
  "publisher": "HL7 International - BR&R Work Group",
  "contact": [
    {
      "name": "HL7 International - Biomedical Research and Regulation",
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org/Special/committees/rcrim"
        }
      ]
    }
  ],
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "urn:iso:std:iso:3166",
          "code": "US",
          "display": "United States of America"
        }
      ],
      "text": "United States of America"
    }
  ],
  "item": [
    {
      "linkId": "mae1",
      "text": "Research Study",
      "_text": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
            "valueString": "color:#274e90; font-size: 150%"
          }
        ]
      },
      "type": "group",
      "required": false,
      "item": [
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
              "valueExpression": {
                "language": "text/fhirpath",
                "expression": "%lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value"
              }
            }
          ],
          "linkId": "mae1.1",
          "text": "Study Title",
          "type": "string",
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae1.1_help",
              "text": "Short title of the study, the same title listed on the Informed Consent",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
              "valueExpression": {
                "language": "text/fhirpath",
                "expression": "%lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value"
              }
            }
          ],
          "linkId": "mae1.2",
          "text": "IRB Protocol Number",
          "type": "string",
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae1.2_help",
              "text": "Number assigned by IRB; this number is the same as that on the Consent Form",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            },
            {
              "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
              "valueExpression": {
                "language": "text/fhirpath",
                "expression": "%lookupInitiateStudy.descendants().where(linkId = 'in1.4').answer.valueCoding"
              }
            }
          ],
          "linkId": "mae1.3",
          "text": "Study Type",
          "type": "choice",
          "required": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "INT",
                "display": "Interventional"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "OBS",
                "display": "Observational"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae1.3_help",
              "text": "Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            },
            {
              "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
              "valueExpression": {
                "language": "text/fhirpath",
                "expression": "%lookupInitiateStudy.descendants().where(linkId = 'in9.1').answer.valueCoding"
              }
            }
          ],
          "linkId": "mae1.4",
          "text": "Does this protocol require an FDA exemption?",
          "type": "choice",
          "required": false,
          "repeats": false,
          "readOnly": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "Y",
                "display": "Yes"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "N",
                "display": "No"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae1.4_help",
              "text": "Indicator for use of FDA regulated product",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            },
            {
              "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
              "valueExpression": {
                "language": "text/fhirpath",
                "expression": "%lookupInitiateStudy.descendants().where(linkId = 'in9.2').answer.valueCoding"
              }
            }
          ],
          "linkId": "mae1.5",
          "text": "Is an IND or IDE being used in this study?",
          "type": "choice",
          "required": false,
          "repeats": false,
          "readOnly": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "Y",
                "display": "Yes"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "N",
                "display": "No"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae1.5_help",
              "text": "Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            },
            {
              "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
              "valueExpression": {
                "language": "text/fhirpath",
                "expression": "%lookupInitiateStudy.descendants().where(linkId = 'in9.4').answer.valueCoding"
              }
            }
          ],
          "linkId": "mae1.6",
          "text": "Select whether Investigational New Drug (IND) or Investigational Device Exemption (IDE):",
          "type": "choice",
          "enableWhen": [
            {
              "question": "mae1.5",
              "operator": "=",
              "answerCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "Y"
              }
            }
          ],
          "required": false,
          "repeats": false,
          "readOnly": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "IND",
                "display": "IND"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "IDE",
                "display": "IDE"
              }
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
              "valueExpression": {
                "language": "text/fhirpath",
                "expression": "%lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value"
              }
            }
          ],
          "linkId": "mae1.7",
          "text": "IND/IDE Number",
          "type": "string",
          "enableWhen": [
            {
              "question": "mae1.5",
              "operator": "=",
              "answerCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "Y"
              }
            }
          ],
          "required": false
        }
      ]
    },
    {
      "linkId": "mae4",
      "text": "Organization/Site",
      "_text": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
            "valueString": "color:#274e90; font-size: 150%"
          }
        ]
      },
      "type": "group",
      "required": false,
      "item": [
        {
          "linkId": "mae4.1",
          "text": "Where Adverse Medical Event Occurred",
          "_text": {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
                "valueString": "color:#2a623d;  font-size: 125%"
              }
            ]
          },
          "type": "group",
          "required": false,
          "repeats": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "drop-down",
                        "display": "Drop down"
                      }
                    ],
                    "text": "Drop down"
                  }
                }
              ],
              "linkId": "mae4.1.7",
              "text": "Did the Adverse Medical Event occur at the lead principal investigator site?",
              "type": "choice",
              "required": true,
              "answerOption": [
                {
                  "valueCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "Y",
                    "display": "Yes"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "N",
                    "display": "No"
                  }
                }
              ],
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae4.1.7_help",
                  "text": "This question and its answer will not print on the Adverse Medical Event Form but are necessary for the form logic. Select \"Yes\" if the Adverse Medical Event occurred at the lead principal investigator site, the study coordinating center or other administrative unit for the overall study.",
                  "type": "display"
                }
              ]
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
                  "valueExpression": {
                    "language": "text/fhirpath",
                    "expression": "%lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value"
                  }
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
                  "valueBoolean": true
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/designNote",
                  "valueMarkdown": "See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic.  Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression)."
                }
              ],
              "linkId": "ExternalDataFor_mae4.1.1",
              "text": "External Data For linkId mae4.1.1",
              "type": "open-choice",
              "required": false,
              "repeats": true
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "drop-down",
                        "display": "Drop down"
                      }
                    ],
                    "text": "Drop down"
                  }
                },
                {
                  "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-answerExpression",
                  "valueExpression": {
                    "language": "text/fhirpath",
                    "expression": "%resource.repeat(item).where(linkId = 'ExternalDataFor_mae4.1.1').answer.value"
                  }
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/designNote",
                  "valueMarkdown": "See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic.  Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression)."
                }
              ],
              "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.",
              "type": "choice",
              "enableWhen": [
                {
                  "question": "mae4.1.7",
                  "operator": "=",
                  "answerCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "N"
                  }
                }
              ],
              "required": false,
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae4.1.1_help",
                  "text": "This question and its answer will not print on the Adverse Medical Event Form but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details.",
                  "type": "display"
                }
              ]
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression": {
                    "language": "text/fhirpath",
                    "expression": "iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value)"
                  }
                }
              ],
              "linkId": "mae4.1.2",
              "text": "Name of organization/site where the event occurred",
              "type": "string",
              "enableWhen": [
                {
                  "question": "mae4.1.7",
                  "operator": "exists",
                  "answerBoolean": true
                }
              ],
              "required": false
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae4.1_help",
              "text": "Location where Adverse Medical Event occurred. Adverse Medical Event is any untoward medical occurrence associated with a participant in research, whether or not associated with the participant's activities in the research.",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae4.7",
          "text": "Site Principal Investigator",
          "_text": {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
                "valueString": "color:#2a623d;  font-size: 125%"
              }
            ]
          },
          "type": "group",
          "enableWhen": [
            {
              "question": "mae4.1.7",
              "operator": "exists",
              "answerBoolean": true
            }
          ],
          "required": false,
          "repeats": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression": {
                    "language": "text/fhirpath",
                    "expression": "iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value)"
                  }
                }
              ],
              "linkId": "mae4.7.1",
              "text": "First Name",
              "type": "string",
              "required": false,
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae4.7.1_help",
                  "text": "First or given name of the principal investigator at site where Adverse Medical Event occurred",
                  "type": "display"
                }
              ]
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression": {
                    "language": "text/fhirpath",
                    "expression": "iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value)"
                  }
                }
              ],
              "linkId": "mae4.7.2",
              "text": "Last Name",
              "type": "string",
              "required": false,
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae4.7.2_help",
                  "text": "Surname or family name",
                  "type": "display"
                }
              ]
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression": {
                    "language": "text/fhirpath",
                    "expression": "iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value)"
                  }
                }
              ],
              "linkId": "mae4.7.5",
              "text": "Suffix",
              "type": "string",
              "required": false,
              "repeats": false,
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae4.7.5_help",
                  "text": "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.",
                  "type": "display"
                }
              ]
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression": {
                    "language": "text/fhirpath",
                    "expression": "iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value)"
                  }
                }
              ],
              "linkId": "mae4.7.6",
              "text": "Degree(s)",
              "type": "string",
              "required": false,
              "repeats": false,
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae4.7.6_help",
                  "text": "Professional and Academic degrees of the principal investigator at site where Adverse Medical Event occurred",
                  "type": "display"
                }
              ]
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression": {
                    "language": "text/fhirpath",
                    "expression": "iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value)"
                  }
                }
              ],
              "linkId": "mae4.7.3",
              "text": "Phone",
              "type": "string",
              "required": false,
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae4.7.3_help",
                  "text": "10-digit phone number, including area code",
                  "type": "display"
                }
              ]
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression": {
                    "language": "text/fhirpath",
                    "expression": "iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value)"
                  }
                }
              ],
              "linkId": "mae4.7.4",
              "text": "Email",
              "type": "string",
              "required": false
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae4.7_help",
              "text": "Principal Investigator at site where Adverse Medical Event occurred",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae4.9",
          "text": "Responsibility for Adverse Medical Event Reporting",
          "_text": {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
                "valueString": "color:#2a623d;  font-size: 125%"
              }
            ]
          },
          "type": "group",
          "enableWhen": [
            {
              "question": "mae4.1.7",
              "operator": "exists",
              "answerBoolean": true
            }
          ],
          "required": false,
          "repeats": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "drop-down",
                        "display": "Drop down"
                      }
                    ],
                    "text": "Drop down"
                  }
                }
              ],
              "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?",
              "type": "choice",
              "enableWhen": [
                {
                  "question": "mae4.1.7",
                  "operator": "=",
                  "answerCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "N"
                  }
                }
              ],
              "required": true,
              "answerOption": [
                {
                  "valueCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "Y",
                    "display": "Yes"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "N",
                    "display": "No"
                  }
                }
              ],
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae4.9.1_help",
                  "text": "Select \"Yes\" if the Adverse Medical Event is being recorded by the lead principal investigator site, the study coordinating center or other administrative unit for the overall study.",
                  "type": "display"
                }
              ]
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression": {
                    "language": "text/fhirpath",
                    "expression": "iif(%eventOccurredAtLeadPISite = 'Y' or %relyingSiteEventReportedByLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, iif(%relyingSiteEventReportedByLeadPISite = 'N', %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value) )"
                  }
                }
              ],
              "linkId": "mae4.9.2",
              "text": "Name of organization/site which is recording the Adverse Medical event",
              "type": "string",
              "enableWhen": [
                {
                  "question": "mae4.1.7",
                  "operator": "=",
                  "answerCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "Y"
                  }
                },
                {
                  "question": "mae4.9.1",
                  "operator": "exists",
                  "answerBoolean": true
                }
              ],
              "enableBehavior": "any",
              "required": false,
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae4.9.2_help",
                  "text": "Location where adverse event is recorded",
                  "type": "display"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "linkId": "mae3",
      "text": "Primary Contact",
      "_text": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
            "valueString": "color:#274e90; font-size: 150%"
          }
        ]
      },
      "type": "group",
      "required": false,
      "item": [
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "help",
                    "display": "Help-Button"
                  }
                ],
                "text": "Help-Button"
              }
            }
          ],
          "linkId": "mae3_help",
          "text": "Personnel completing the adverse medical event documentation at the lead or relying site",
          "type": "display"
        },
        {
          "linkId": "mae3.1",
          "text": "First Name",
          "type": "string",
          "required": false,
          "repeats": false,
          "readOnly": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae3.1_help",
              "text": "First or given name",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae3.2",
          "text": "Last Name",
          "type": "string",
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae3.2_help",
              "text": "Surname or family name",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae3.3",
          "text": "Phone",
          "type": "string",
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae3.3_help",
              "text": "10-digit phone number, including area code",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae3.4",
          "text": "Email",
          "type": "string",
          "required": false
        }
      ]
    },
    {
      "linkId": "mae5",
      "text": "Participant Information",
      "_text": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
            "valueString": "color:#274e90; font-size: 150%"
          }
        ]
      },
      "type": "group",
      "required": false,
      "item": [
        {
          "linkId": "mae5.1",
          "text": "Patient ID",
          "type": "string",
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae5.1_help",
              "text": "Participant identifier from study case report form",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae5.2",
          "text": "Age",
          "type": "string",
          "required": false
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae5.3",
          "text": "Birth Sex",
          "type": "choice",
          "required": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0001",
                "code": "F",
                "display": "Female"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0001",
                "code": "M",
                "display": "Male"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0001",
                "code": "O",
                "display": "Other"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0001",
                "code": "U",
                "display": "Unknown"
              }
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption",
              "valueCoding": {
                "display": "[lb]"
              }
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption",
              "valueCoding": {
                "display": "[kg]"
              }
            }
          ],
          "linkId": "mae5.4",
          "text": "Weight",
          "type": "quantity",
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae5.4_help",
              "text": "Select pounds or kilograms",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption",
              "valueCoding": {
                "display": "[in]"
              }
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption",
              "valueCoding": {
                "display": "[ft]"
              }
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption",
              "valueCoding": {
                "display": "[cm]"
              }
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption",
              "valueCoding": {
                "display": "[m]"
              }
            }
          ],
          "linkId": "mae5.5",
          "text": "Height",
          "type": "quantity",
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae5.5_help",
              "text": "Select inches, feet, centimeters, meters",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae5.6",
          "text": "Ethnicity",
          "type": "choice",
          "required": false,
          "repeats": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v3-Ethnicity",
                "code": "2135-2",
                "display": "Hispanic or Latino"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v3-Ethnicity",
                "code": "2186-5",
                "display": "Not Hispanic or Latino"
              }
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "check-box",
                    "display": "Check-box"
                  }
                ],
                "text": "Check-box"
              }
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
              "valueCode": "vertical"
            }
          ],
          "linkId": "mae5.7",
          "text": "Race",
          "type": "choice",
          "required": false,
          "repeats": true,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v3-Race",
                "code": "2028-9",
                "display": "Asian"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v3-Race",
                "code": "1002-5",
                "display": "American Indian or Alaska Native"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v3-Race",
                "code": "2054-5",
                "display": "Black or African American"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v3-Race",
                "code": "2076-8",
                "display": "Native Hawaiian or Other Pacific Islander"
              }
            },
            {
              "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)?",
          "type": "string",
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae5.8_help",
              "text": "Patient's treatment strategy assignment, if known.",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae5.9",
          "text": "Participant dosed or received study agent",
          "type": "choice",
          "required": false,
          "repeats": false,
          "readOnly": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "Y",
                "display": "Yes"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "N",
                "display": "No"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "NI",
                "display": "No Information"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "NA",
                "display": "not applicable"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae5.9_help",
              "text": "Did the participant receive the investigational agent? If answer is unknown due to blinding, select No Information.",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae5.10",
          "text": "What study agent was received:",
          "type": "choice",
          "enableWhen": [
            {
              "question": "mae5.9",
              "operator": "=",
              "answerCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "Y"
              }
            },
            {
              "question": "mae5.9",
              "operator": "=",
              "answerCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "NI"
              }
            }
          ],
          "enableBehavior": "any",
          "required": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "SA",
                "display": "Study Agent"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "PLACEBO",
                "display": "Placebo"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "BSA",
                "display": "Blinded Study Agent"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae5.10_help",
              "text": "investigational agent or placebo or blinded study",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae5.11",
          "text": "Were there any Protocol Deviations/Violations/Exceptions for this participant?",
          "type": "choice",
          "required": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "Y",
                "display": "Yes"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "N",
                "display": "No"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae5.11_help",
              "text": "Indicator if adverse medical event occurred with protocol deviation, violation, exception",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae5.12",
          "text": "Describe the Protocol Deviations/Violations/Exceptions",
          "type": "text",
          "enableWhen": [
            {
              "question": "mae5.11",
              "operator": "=",
              "answerCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "Y"
              }
            }
          ],
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "flyover"
                      }
                    ]
                  }
                }
              ],
              "linkId": "mae5.12_help",
              "text": "Description of protocol deviations, violations, or exceptions that occurred for this participant",
              "type": "display"
            }
          ]
        }
      ]
    },
    {
      "linkId": "mae6",
      "text": "Adverse Medical Event Information",
      "_text": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
            "valueString": "color:#274e90; font-size: 150%"
          }
        ]
      },
      "type": "group",
      "required": false,
      "item": [
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae6.1",
          "text": "Submission Type",
          "type": "choice",
          "required": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "INITIAL",
                "display": "Initial"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "UPDATE",
                "display": "Update"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.1_help",
              "text": "Initial: the first time that the adverse medical event is reported \r\nor\r\nUpdate: update on a previously reported adverse medical event",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae6.2",
          "text": "Start Date",
          "type": "date",
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.2_help",
              "text": "Date adverse event started",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae6.3",
          "text": "Reported Date",
          "type": "date",
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.3_help",
              "text": "Date of this report",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae6.4",
          "text": "Recorded Date",
          "type": "date",
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.4_help",
              "text": "Date this adverse event was first recorded",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae6.10",
          "text": "Is the Adverse Medical Event Serious?",
          "type": "choice",
          "required": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
                "code": "serious",
                "display": "Serious"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
                "code": "non-serious",
                "display": "Non-serious"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.10_help",
              "text": "Event is considered serious and reportable to the FDA in the following outcomes: death, life-threatening, hospitalization, disability or permanent damage, congenital anaomaly/birth defect, need for required intervention to prevent permanent impairment or damage. See FDA Guidance: https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae6.9",
          "text": "Severity",
          "type": "choice",
          "required": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
                "code": "mild",
                "display": "Mild"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
                "code": "moderate",
                "display": "Moderate"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
                "code": "severe",
                "display": "Severe"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.9_help",
              "text": "Physician assessment using sponsor defined categories",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae6.40",
          "text": "Narrative of the Adverse Event:",
          "type": "text",
          "enableWhen": [
            {
              "question": "mae6.10",
              "operator": "=",
              "answerCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
                "code": "serious"
              }
            }
          ],
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.40_help",
              "text": "Description of the SAE including chronological clinical presentation and evolution of the SAE and associated signs/symptoms. Serious Medical Event criteria are defined in the protocol.",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae6.5",
          "text": "Medical Description of Adverse Event",
          "type": "text",
          "required": false,
          "repeats": false,
          "readOnly": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.5_help",
              "text": "Diagnosis associated with adverse event. Any untoward medical occurrence associated with the use of a drug or device, whether or not considered related to the drug or device.",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae6.6",
          "text": "Is the Adverse Medical event still ongoing?",
          "type": "choice",
          "required": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "Y",
                "display": "Yes"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "N",
                "display": "No"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.6_help",
              "text": "Indicator if the adverse event is still continuing or has been resolved.",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae6.7",
          "text": "Stop Date",
          "type": "date",
          "enableWhen": [
            {
              "question": "mae6.6",
              "operator": "=",
              "answerCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "N"
              }
            }
          ],
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.7_help",
              "text": "Date that the event resolved",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae6.8",
          "text": "Was the event expected?",
          "type": "choice",
          "required": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0239",
                "code": "Y",
                "display": "Yes"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0239",
                "code": "N",
                "display": "No"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.8_help",
              "text": "Indicator that Adverse Medical Event was expected or not expected.",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae6.11",
          "text": "Seriousness",
          "_text": {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
                "valueString": "color:#2a623d;  font-size: 125%"
              }
            ]
          },
          "type": "group",
          "enableWhen": [
            {
              "question": "mae6.10",
              "operator": "=",
              "answerCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
                "code": "serious"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "drop-down",
                        "display": "Drop down"
                      }
                    ],
                    "text": "Drop down"
                  }
                }
              ],
              "linkId": "mae6.11.1",
              "text": "Seriousness",
              "type": "choice",
              "enableWhen": [
                {
                  "question": "mae6.10",
                  "operator": "=",
                  "answerCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
                    "code": "serious"
                  }
                }
              ],
              "required": false,
              "answerOption": [
                {
                  "valueCoding": {
                    "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code": "ResultsInDeath",
                    "display": "Results in death"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code": "IsLifeThreatening",
                    "display": "Is Life-threatening"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code": "ResultsInHospitalization",
                    "display": "Requires or prolongs inpatient hospitalization"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code": "IsBirthDefect",
                    "display": "Is a congenital anomaly/birth defect"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code": "ResultsInDisability",
                    "display": "Results in persistent or significant disability/incapacity"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code": "RequiresPreventImpairment",
                    "display": "Requires intervention to prevent permanent impairment"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code": "Other",
                    "display": "Other"
                  }
                }
              ],
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae6.11.1_help",
                  "text": "An adverse event is considered \"serious\" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. DFR Title 21, Part 312, Subpart B, Sec. 312.32",
                  "type": "display"
                }
              ]
            },
            {
              "linkId": "mae6.11.2",
              "text": "Other-specify",
              "type": "text",
              "enableWhen": [
                {
                  "question": "mae6.11.1",
                  "operator": "=",
                  "answerCoding": {
                    "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code": "Other"
                  }
                }
              ],
              "required": false,
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae6.11.2_help",
                  "text": "Describe other serious consequences or other medically important condition",
                  "type": "display"
                }
              ]
            }
          ]
        },
        {
          "linkId": "mae6.12",
          "text": "What is the date Adverse Medical Event became serious?",
          "type": "date",
          "enableWhen": [
            {
              "question": "mae6.10",
              "operator": "=",
              "answerCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
                "code": "serious"
              }
            }
          ],
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.12_help",
              "text": "Date adverse event was deemed as serious",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae6.13",
          "text": "Outcome of Adverse Medical Event",
          "type": "choice",
          "required": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "RCVRED",
                "display": "recovered/resolved"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "RCVRING",
                "display": "recovering/resolving"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "NRCVRED",
                "display": "not recovered/not resolved/ongoing"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "SEQL",
                "display": "recovered/resolved with sequelae"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "FATAL",
                "display": "fatal"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "UNK",
                "display": "unknown"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.13_help",
              "text": "Participant's status after the adverse event",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae6.14",
          "text": "Was autopsy performed?",
          "type": "choice",
          "enableWhen": [
            {
              "question": "mae6.13",
              "operator": "=",
              "answerCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "FATAL"
              }
            }
          ],
          "required": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "Y",
                "display": "Yes"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "N",
                "display": "No"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "UNK",
                "display": "Unknown"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.14_help",
              "text": "Indicator if participant was autopsied",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae6.15",
          "text": "Relationship of Adverse Medical Event to Study Intervention",
          "type": "choice",
          "required": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
                "code": "certain",
                "display": "Certain"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
                "code": "probably-likely",
                "display": "Probably/Likely"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
                "code": "possible",
                "display": "Possible"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
                "code": "unlikely",
                "display": "Unlikely"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
                "code": "conditional-classified",
                "display": "Conditional/Classified"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
                "code": "unassessable-unclassifiable",
                "display": "Unassessable/Unclassifiable"
              }
            }
          ]
        },
        {
          "linkId": "mae6.16",
          "text": "Rationale for relationship with study intervention",
          "type": "text",
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.16_help",
              "text": "Explanation for relationship between study intervention and adverse event. You may also discuss why the AE appears to be unrelated or why it is not possible to determine the relationship.",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae6.17",
          "text": "If applicable, what are possible alternate causes of the Adverse Medical Event?",
          "type": "choice",
          "required": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "PRMYDIS",
                "display": "Primary disease"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "STDYPRO",
                "display": "Study Procedure"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "PRE",
                "display": "Pre-existing condition"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "UNDERLYINGDIS",
                "display": "Underlying disease"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "CONCMITMED",
                "display": "Concomitant medication"
              }
            },
            {
              "valueCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "OTHERCAUSE",
                "display": "Other known or suspected cause"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.17_help",
              "text": "Reason for possible alternative serious adverse event causes",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae6.18",
          "text": "Study Procedure-specify",
          "type": "text",
          "enableWhen": [
            {
              "question": "mae6.17",
              "operator": "=",
              "answerCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "STDYPRO"
              }
            }
          ],
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.18_help",
              "text": "Study procedure associated with SAE",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae6.19",
          "text": "Pre-existing condition-specify",
          "type": "text",
          "enableWhen": [
            {
              "question": "mae6.17",
              "operator": "=",
              "answerCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "PRE"
              }
            }
          ],
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.19_help",
              "text": "Pre-existing condition associated with SAE",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae6.20",
          "text": "Underlying disease-specify",
          "type": "text",
          "enableWhen": [
            {
              "question": "mae6.17",
              "operator": "=",
              "answerCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "UNDERLYINGDIS"
              }
            }
          ],
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.20_help",
              "text": "Underlying disease associated with SAE",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae6.21",
          "text": "Concomittant medication-specify",
          "type": "text",
          "enableWhen": [
            {
              "question": "mae6.17",
              "operator": "=",
              "answerCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "CONCMITMED"
              }
            }
          ],
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.21_help",
              "text": "Concomitant medication associated with SAE",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae6.22",
          "text": "Other known or suspected cause-specify",
          "type": "text",
          "enableWhen": [
            {
              "question": "mae6.17",
              "operator": "=",
              "answerCoding": {
                "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code": "OTHERCAUSE"
              }
            }
          ],
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.22_help",
              "text": "Description of other causal reason associated with SAE",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae6.23",
          "text": "Action Taken",
          "_text": {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
                "valueString": "color:#2a623d;  font-size: 125%"
              }
            ]
          },
          "type": "group",
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "drop-down",
                        "display": "Drop down"
                      }
                    ],
                    "text": "Drop down"
                  }
                }
              ],
              "linkId": "mae6.23.1",
              "text": "Action Taken Regarding Study Intervention",
              "type": "choice",
              "required": false,
              "answerOption": [
                {
                  "valueCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0251",
                    "code": "WP",
                    "display": "Product withdrawn permanently"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0251",
                    "code": "WT",
                    "display": "Product withdrawn temporarily"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0251",
                    "code": "DR",
                    "display": "Product dose or frequency of use reduced"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0251",
                    "code": "DI",
                    "display": "Product dose or frequency of use increased"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code": "NC",
                    "display": "Product dose or frequency of use not changed"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code": "UNK",
                    "display": "Unknown"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code": "NA",
                    "display": "Not applicable"
                  }
                }
              ],
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae6.23.1_help",
                  "text": "Changes to study intervention made after adverse event was detected",
                  "type": "display"
                }
              ]
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae6.24",
          "text": "If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate?",
          "type": "choice",
          "required": false,
          "repeats": false,
          "readOnly": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "Y",
                "display": "Yes"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "N",
                "display": "No"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "NA",
                "display": "not applicable"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.24_help",
              "text": "Adverse event diminished/abated after study intervention was discontinued, interrupted, or dose reduced (dechallenged)",
              "type": "display"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "drop-down",
                    "display": "Drop down"
                  }
                ],
                "text": "Drop down"
              }
            }
          ],
          "linkId": "mae6.25",
          "text": "If study intervention was restarted (rechallenge) did AE recur?",
          "type": "choice",
          "required": false,
          "repeats": false,
          "readOnly": false,
          "answerOption": [
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "Y",
                "display": "Yes"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "N",
                "display": "No"
              }
            },
            {
              "valueCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code": "NA",
                "display": "not applicable"
              }
            }
          ],
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "mae6.25_help",
              "text": "Adverse event recurred when the study intervention was restarted",
              "type": "display"
            }
          ]
        },
        {
          "linkId": "mae6.50",
          "text": "SAE Concomitant Medications, Treatments/Procedures and Tests",
          "_text": {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
                "valueString": "color:#2a623d;  font-size: 125%"
              }
            ]
          },
          "type": "group",
          "enableWhen": [
            {
              "question": "mae6.10",
              "operator": "=",
              "answerCoding": {
                "system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
                "code": "serious"
              }
            }
          ],
          "required": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "drop-down",
                        "display": "Drop down"
                      }
                    ],
                    "text": "Drop down"
                  }
                }
              ],
              "linkId": "mae6.50.26",
              "text": "Did the participant receive any relevant concomitant medications in response to the SAE?",
              "type": "choice",
              "enableWhen": [
                {
                  "question": "mae6.10",
                  "operator": "=",
                  "answerCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
                    "code": "serious"
                  }
                }
              ],
              "required": false,
              "answerOption": [
                {
                  "valueCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "Y",
                    "display": "Yes"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "N",
                    "display": "No"
                  }
                }
              ]
            },
            {
              "linkId": "mae6.50.28",
              "text": "SAE Concomitant Medications",
              "type": "group",
              "enableWhen": [
                {
                  "question": "mae6.50.26",
                  "operator": "=",
                  "answerCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "Y"
                  }
                }
              ],
              "required": false,
              "repeats": true,
              "item": [
                {
                  "linkId": "mae6.50.28.1",
                  "text": "Medication Name",
                  "type": "string",
                  "required": false,
                  "item": [
                    {
                      "extension": [
                        {
                          "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                          "valueCodeableConcept": {
                            "coding": [
                              {
                                "system": "http://hl7.org/fhir/questionnaire-item-control",
                                "code": "help",
                                "display": "Help-Button"
                              }
                            ],
                            "text": "Help-Button"
                          }
                        }
                      ],
                      "linkId": "mae6.50.28.1_help",
                      "text": "Name of concomitant medication given to participant in response to SAE",
                      "type": "display"
                    }
                  ]
                },
                {
                  "linkId": "mae6.50.28.2",
                  "text": "Indication",
                  "type": "string",
                  "required": false,
                  "item": [
                    {
                      "extension": [
                        {
                          "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                          "valueCodeableConcept": {
                            "coding": [
                              {
                                "system": "http://hl7.org/fhir/questionnaire-item-control",
                                "code": "help",
                                "display": "Help-Button"
                              }
                            ],
                            "text": "Help-Button"
                          }
                        }
                      ],
                      "linkId": "mae6.50.28.2_help",
                      "text": "Indication for giving the concomitant medication to participant",
                      "type": "display"
                    }
                  ]
                },
                {
                  "linkId": "mae6.50.28.3",
                  "text": "Start Date",
                  "type": "date",
                  "required": false,
                  "item": [
                    {
                      "extension": [
                        {
                          "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                          "valueCodeableConcept": {
                            "coding": [
                              {
                                "system": "http://hl7.org/fhir/questionnaire-item-control",
                                "code": "help",
                                "display": "Help-Button"
                              }
                            ],
                            "text": "Help-Button"
                          }
                        }
                      ],
                      "linkId": "mae6.50.28.3_help",
                      "text": "Start date for the concomitant medication given to participant",
                      "type": "display"
                    }
                  ]
                },
                {
                  "linkId": "mae6.50.28.4",
                  "text": "Stop Date",
                  "type": "date",
                  "required": false,
                  "item": [
                    {
                      "extension": [
                        {
                          "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                          "valueCodeableConcept": {
                            "coding": [
                              {
                                "system": "http://hl7.org/fhir/questionnaire-item-control",
                                "code": "help",
                                "display": "Help-Button"
                              }
                            ],
                            "text": "Help-Button"
                          }
                        }
                      ],
                      "linkId": "mae6.50.28.4_help",
                      "text": "Stop date for the concomitant medication given to the participant",
                      "type": "display"
                    }
                  ]
                },
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "gtable",
                            "display": "Group Table"
                          }
                        ],
                        "text": "Group Table"
                      }
                    }
                  ],
                  "linkId": "mae6.50.28.5",
                  "text": "Ongoing",
                  "type": "choice",
                  "required": false,
                  "answerOption": [
                    {
                      "valueCoding": {
                        "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                        "code": "Y",
                        "display": "Yes"
                      }
                    },
                    {
                      "valueCoding": {
                        "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                        "code": "N",
                        "display": "No"
                      }
                    }
                  ],
                  "item": [
                    {
                      "extension": [
                        {
                          "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                          "valueCodeableConcept": {
                            "coding": [
                              {
                                "system": "http://hl7.org/fhir/questionnaire-item-control",
                                "code": "help",
                                "display": "Help-Button"
                              }
                            ],
                            "text": "Help-Button"
                          }
                        }
                      ],
                      "linkId": "mae6.50.28.5_help",
                      "text": "Is concomitant medication administration for participant ongoing?",
                      "type": "display"
                    }
                  ]
                },
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae6.50.28_help",
                  "text": "Concomitant medication associated with SAE",
                  "type": "display"
                }
              ]
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "drop-down",
                        "display": "Drop down"
                      }
                    ],
                    "text": "Drop down"
                  }
                }
              ],
              "linkId": "mae6.50.29",
              "text": "Did the participant receive any treatments/procedures in response to the SAE?",
              "type": "choice",
              "enableWhen": [
                {
                  "question": "mae6.10",
                  "operator": "=",
                  "answerCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
                    "code": "serious"
                  }
                }
              ],
              "required": false,
              "answerOption": [
                {
                  "valueCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "Y",
                    "display": "Yes"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "N",
                    "display": "No"
                  }
                }
              ],
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae6.50.29_help",
                  "text": "Treatments/procedures administered in response to SAE",
                  "type": "display"
                }
              ]
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "gtable",
                        "display": "Group Table"
                      }
                    ],
                    "text": "Group Table"
                  }
                }
              ],
              "linkId": "mae6.50.30",
              "text": "SAE Treatments/Procedures",
              "type": "group",
              "enableWhen": [
                {
                  "question": "mae6.50.29",
                  "operator": "=",
                  "answerCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "Y"
                  }
                }
              ],
              "required": false,
              "repeats": true,
              "item": [
                {
                  "linkId": "mae6.50.30.1",
                  "text": "Treatment/Procedure",
                  "type": "string",
                  "required": false,
                  "item": [
                    {
                      "extension": [
                        {
                          "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                          "valueCodeableConcept": {
                            "coding": [
                              {
                                "system": "http://hl7.org/fhir/questionnaire-item-control",
                                "code": "help",
                                "display": "Help-Button"
                              }
                            ],
                            "text": "Help-Button"
                          }
                        }
                      ],
                      "linkId": "mae6.50.30.1_help",
                      "text": "Name of SAE treatment/procedure participant received",
                      "type": "display"
                    }
                  ]
                },
                {
                  "linkId": "mae6.50.30.2",
                  "text": "Start Date",
                  "type": "date",
                  "required": false,
                  "item": [
                    {
                      "extension": [
                        {
                          "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                          "valueCodeableConcept": {
                            "coding": [
                              {
                                "system": "http://hl7.org/fhir/questionnaire-item-control",
                                "code": "help",
                                "display": "Help-Button"
                              }
                            ],
                            "text": "Help-Button"
                          }
                        }
                      ],
                      "linkId": "mae6.50.30.2_help",
                      "text": "Start date for SAE treatment/procedure participant received",
                      "type": "display"
                    }
                  ]
                },
                {
                  "linkId": "mae6.50.30.3",
                  "text": "Stop Date",
                  "type": "date",
                  "required": false,
                  "item": [
                    {
                      "extension": [
                        {
                          "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                          "valueCodeableConcept": {
                            "coding": [
                              {
                                "system": "http://hl7.org/fhir/questionnaire-item-control",
                                "code": "help",
                                "display": "Help-Button"
                              }
                            ],
                            "text": "Help-Button"
                          }
                        }
                      ],
                      "linkId": "mae6.50.30.3_help",
                      "text": "Stop date for SAE treatment/procedure participant received",
                      "type": "display"
                    }
                  ]
                },
                {
                  "linkId": "mae6.50.30.4",
                  "text": "Ongoing",
                  "type": "choice",
                  "required": false,
                  "answerOption": [
                    {
                      "valueCoding": {
                        "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                        "code": "Y",
                        "display": "Yes"
                      }
                    },
                    {
                      "valueCoding": {
                        "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                        "code": "N",
                        "display": "No"
                      }
                    }
                  ],
                  "item": [
                    {
                      "extension": [
                        {
                          "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                          "valueCodeableConcept": {
                            "coding": [
                              {
                                "system": "http://hl7.org/fhir/questionnaire-item-control",
                                "code": "help",
                                "display": "Help-Button"
                              }
                            ],
                            "text": "Help-Button"
                          }
                        }
                      ],
                      "linkId": "mae6.50.30.4_help",
                      "text": "Is the SAE treatment/procedure for the participant ongoing",
                      "type": "display"
                    }
                  ]
                },
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae6.50.30_help",
                  "text": "SAE treatment/procedure participant received",
                  "type": "display"
                }
              ]
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "drop-down",
                        "display": "Drop down"
                      }
                    ],
                    "text": "Drop down"
                  }
                }
              ],
              "linkId": "mae6.50.37",
              "text": "Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?",
              "type": "choice",
              "enableWhen": [
                {
                  "question": "mae6.10",
                  "operator": "=",
                  "answerCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
                    "code": "serious"
                  }
                }
              ],
              "required": false,
              "answerOption": [
                {
                  "valueCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "Y",
                    "display": "Yes"
                  }
                },
                {
                  "valueCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "N",
                    "display": "No"
                  }
                }
              ],
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae6.50.37_help",
                  "text": "Were any laboratory or diagnostic tests administered to the participant in response to the SAE?",
                  "type": "display"
                }
              ]
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "gtable",
                        "display": "Group Table"
                      }
                    ],
                    "text": "Group Table"
                  }
                }
              ],
              "linkId": "mae6.50.38",
              "text": "SAE Laboratory or Diagnostic Tests",
              "type": "group",
              "enableWhen": [
                {
                  "question": "mae6.50.37",
                  "operator": "=",
                  "answerCoding": {
                    "system": "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code": "Y"
                  }
                }
              ],
              "required": false,
              "repeats": true,
              "item": [
                {
                  "linkId": "mae6.50.38.1",
                  "text": "Lab/Diagnostic Test",
                  "type": "string",
                  "required": false
                },
                {
                  "linkId": "mae6.50.38.2",
                  "text": "Date",
                  "type": "date",
                  "required": false
                },
                {
                  "linkId": "mae6.50.38.3",
                  "text": "Result",
                  "type": "string",
                  "required": false
                },
                {
                  "linkId": "mae6.50.38.4",
                  "text": "Low Range",
                  "type": "string",
                  "required": false
                },
                {
                  "linkId": "mae6.50.38.5",
                  "text": "High Range",
                  "type": "string",
                  "required": false
                },
                {
                  "linkId": "mae6.50.38.6",
                  "text": "Comments",
                  "type": "string",
                  "required": false
                },
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "mae6.50.38_help",
                  "text": "Laboratory or diagnostic tests obtained in response to SAE",
                  "type": "display"
                }
              ]
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "help",
                    "display": "Help-Button"
                  }
                ],
                "text": "Help-Button"
              }
            }
          ],
          "linkId": "mae6_help",
          "text": "An event that (1) is more likely than not related to study activities; and (2) represents a new risk; and (3) is unanticipated. In addition, an expected event that is occurring at a frequency or intensity greater than originally anticipated.",
          "type": "display"
        }
      ]
    },
    {
      "linkId": "mae11",
      "text": "Optional Attachments",
      "_text": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
            "valueString": "color:#274e90; font-size: 150%"
          }
        ]
      },
      "type": "group",
      "required": false,
      "repeats": true,
      "item": [
        {
          "linkId": "mae11.1",
          "text": "Describe the file that is being attached (optional)",
          "type": "string"
        },
        {
          "linkId": "mae11.2",
          "text": "Attachment",
          "type": "attachment"
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/questionnaire-item-control",
                    "code": "help",
                    "display": "Help-Button"
                  }
                ],
                "text": "Help-Button"
              }
            }
          ],
          "linkId": "mae11_help",
          "text": "Attachments related to the Adverse Event Report can be included here.",
          "type": "display"
        }
      ]
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
          "valueBoolean": true
        }
      ],
      "linkId": "ADMIN00",
      "text": "Administrative Use Only",
      "type": "group",
      "item": [
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean": true
            }
          ],
          "linkId": "ADMIN01",
          "text": "Link ID prefix",
          "type": "string",
          "required": false,
          "initial": [
            {
              "valueString": "mae"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean": true
            },
            {
              "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
              "valueExpression": {
                "language": "text/fhirpath",
                "expression": "%lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value"
              }
            }
          ],
          "linkId": "ADMIN02",
          "text": "Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any",
          "type": "string",
          "required": false,
          "initial": [
            {
              "valueString": "temporarily unavailable"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean": true
            },
            {
              "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
              "valueExpression": {
                "language": "text/fhirpath",
                "expression": "%lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value"
              }
            }
          ],
          "linkId": "ADMIN03",
          "text": "ID of the Research Study FHIR Resource associated with the study Questionnaire Responses",
          "type": "string",
          "required": false,
          "initial": [
            {
              "valueString": "temporarily unavailable"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean": true
            }
          ],
          "linkId": "ADMIN04",
          "text": "Questionnaire Response ID of the local considerations Questionnaire Response, if any",
          "type": "string",
          "required": false
        }
      ]
    }
  ]
}