Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use

Single Institutional Review Board (sIRB) Implementation Guide, published by HL7 International - BR&R Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/fhir-sirb/ and changes regularly. See the Directory of published versions

## Questionnaire: Adverse Medical Event Questionnaire

Official URL: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate | Version: 1.0.0
Draft as of 2023-04-24 | Computable Name: AE_Questionnaire

Structure

LinkId | Text | Cardinality | Type | Flags | Description & Constraints
--- | --- | --- | --- | --- | ---
AE_Questionnaire |  |  | Questionnaire |  | http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate#1.0.0
mae1 | Research Study | 0..1 | group |  |
mae1.1 | Study Title | 0..1 | string |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value`
mae1.1_help | Short title of the study, the same title listed on the Informed Consent | 0..1 | display |  |
mae1.2 | IRB Protocol Number | 0..1 | string |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value`
mae1.2_help | Number assigned by IRB; this number is the same as that on the Consent Form | 0..1 | display |  |
mae1.3 | Study Type | 0..1 | choice |  | Options: 2 options Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in1.4').answer.valueCoding`
mae1.3_help | Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional) | 0..1 | display |  |
mae1.4 | Does this protocol require an FDA exemption? | 0..1 | choice |  | Options: 2 options Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in9.1').answer.valueCoding`
mae1.4_help | Indicator for use of FDA regulated product | 0..1 | display |  |
mae1.5 | Is an IND or IDE being used in this study? | 0..1 | choice |  | Options: 2 options Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in9.2').answer.valueCoding`
mae1.5_help | Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used? | 0..1 | display |  |
mae1.6 | Select whether Investigational New Drug (IND) or Investigational Device Exemption (IDE): | 0..1 | choice |  | Enable When: mae1.5 = Yes (expandedYes-NoIndicator#Y) Options: 2 options Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in9.4').answer.valueCoding`
mae1.7 | IND/IDE Number | 0..1 | string |  | Enable When: mae1.5 = Yes (expandedYes-NoIndicator#Y) Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value`
mae4 | Organization/Site | 0..1 | group |  |
mae4.1 | Where Adverse Medical Event Occurred | 0..1 | group |  |
mae4.1.7 | Did the Adverse Medical Event occur at the lead principal investigator site? | 1..1 | choice |  | Options: 2 options
mae4.1.7_help | 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. | 0..1 | display |  |
ExternalDataFor_mae4.1.1 | External Data For linkId mae4.1.1 | 0..* | open-choice |  | Expressions: Initial Value: `%lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value`
mae4.1.1 | If the Adverse Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the the relying institution and relying site principal investigator details below. | 0..1 | choice |  | Enable When: mae4.1.7 = No (expandedYes-NoIndicator#N)
mae4.1.1_help | 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. | 0..1 | display |  |
mae4.1.2 | Name of organization/site where the event occurred | 0..1 | string |  | Enable 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_help | 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. | 0..1 | display |  |
mae4.7 | Site Principal Investigator | 0..1 | group |  | Enable When: mae4.1.7 exists true
mae4.7.1 | First Name | 0..1 | string |  | Expressions: 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_help | First or given name of the principal investigator at site where Adverse Medical Event occurred | 0..1 | display |  |
mae4.7.2 | Last Name | 0..1 | string |  | Expressions: 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_help | Surname or family name | 0..1 | display |  |
mae4.7.5 | Suffix | 0..1 | string |  | Expressions: 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_help | Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. | 0..1 | display |  |
mae4.7.6 | Degree(s) | 0..1 | string |  | Expressions: 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_help | Professional and Academic degrees of the principal investigator at site where Adverse Medical Event occurred | 0..1 | display |  |
mae4.7.3 | Phone | 0..1 | string |  | Expressions: 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_help | 10-digit phone number, including area code | 0..1 | display |  |
mae4.7.4 | Email | 0..1 | string |  | Expressions: 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_help | Principal Investigator at site where Adverse Medical Event occurred | 0..1 | display |  |
mae4.9 | Responsibility for Adverse Medical Event Reporting | 0..1 | group |  | Enable When: mae4.1.7 exists true
mae4.9.1 | If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be recording the Adverse Non-Medical Event? | 1..1 | choice |  | Enable When: mae4.1.7 = No (expandedYes-NoIndicator#N) Options: 2 options
mae4.9.1_help | 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. | 0..1 | display |  |
mae4.9.2 | Name of organization/site which is recording the Adverse Medical event | 0..1 | string |  | Enable When: mae4.1.7 = Yes (expandedYes-NoIndicator#Y) mae4.9.1 exists true 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_help | Location where adverse event is recorded | 0..1 | display |  |
mae3 | Primary Contact | 0..1 | group |  |
mae3_help | Personnel completing the adverse medical event documentation at the lead or relying site | 0..1 | display |  |
mae3.1 | First Name | 0..1 | string |  |
mae3.1_help | First or given name | 0..1 | display |  |
mae3.2 | Last Name | 0..1 | string |  |
mae3.2_help | Surname or family name | 0..1 | display |  |
mae3.3 | Phone | 0..1 | string |  |
mae3.3_help | 10-digit phone number, including area code | 0..1 | display |  |
mae3.4 | Email | 0..1 | string |  |
mae5 | Participant Information | 0..1 | group |  |
mae5.1 | Patient ID | 0..1 | string |  |
mae5.1_help | Participant identifier from study case report form | 0..1 | display |  |
mae5.2 | Age | 0..1 | string |  |
mae5.3 | Birth Sex | 0..1 | choice |  | Options: 4 options
mae5.4 | Weight | 0..1 | quantity |  |
mae5.4_help | Select pounds or kilograms | 0..1 | display |  |
mae5.5 | Height | 0..1 | quantity |  |
mae5.5_help | Select inches, feet, centimeters, meters | 0..1 | display |  |
mae5.6 | Ethnicity | 0..1 | choice |  | Options: 2 options
mae5.7 | Race | 0..* | choice |  | Options: 5 options
mae5.8 | Which Arm/Cohort/treatment group was the participant assigned to (if known)? | 0..1 | string |  |
mae5.8_help | Patient's treatment strategy assignment, if known. | 0..1 | display |  |
mae5.9 | Participant dosed or received study agent | 0..1 | choice |  | Options: 4 options
mae5.9_help | Did the participant receive the investigational agent? If answer is unknown due to blinding, select No Information. | 0..1 | display |  |
mae5.10 | What study agent was received: | 0..1 | choice |  | Enable When: mae5.9 = Yes (expandedYes-NoIndicator#Y) mae5.9 = No Information (expandedYes-NoIndicator#NI) Options: 3 options
mae5.10_help | investigational agent or placebo or blinded study | 0..1 | display |  |
mae5.11 | Were there any Protocol Deviations/Violations/Exceptions for this participant? | 0..1 | choice |  | Options: 2 options
mae5.11_help | Indicator if adverse medical event occurred with protocol deviation, violation, exception | 0..1 | display |  |
mae5.12 | Describe the Protocol Deviations/Violations/Exceptions | 0..1 | text |  | Enable When: mae5.11 = Yes (expandedYes-NoIndicator#Y)
mae5.12_help | Description of protocol deviations, violations, or exceptions that occurred for this participant | 0..1 | display |  |
mae6 | Adverse Medical Event Information | 0..1 | group |  |
mae6.1 | Submission Type | 0..1 | choice |  | Options: 2 options
mae6.1_help | Initial: the first time that the adverse medical event is reported or Update: update on a previously reported adverse medical event | 0..1 | display |  |
mae6.2 | Start Date | 0..1 | date |  |
mae6.2_help | Date adverse event started | 0..1 | display |  |
mae6.3 | Reported Date | 0..1 | date |  |
mae6.3_help | Date of this report | 0..1 | display |  |
mae6.4 | Recorded Date | 0..1 | date |  |
mae6.4_help | Date this adverse event was first recorded | 0..1 | display |  |
mae6.10 | Is the Adverse Medical Event Serious? | 0..1 | choice |  | Options: 2 options
mae6.10_help | 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 | 0..1 | display |  |
mae6.9 | Severity | 0..1 | choice |  | Options: 3 options
mae6.9_help | Physician assessment using sponsor defined categories | 0..1 | display |  |
mae6.40 | Narrative of the Adverse Event: | 0..1 | text |  | Enable When: mae6.10 = Serious (AdverseEventSeriousness#serious)
mae6.40_help | 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. | 0..1 | display |  |
mae6.5 | Medical Description of Adverse Event | 0..1 | text |  |
mae6.5_help | 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. | 0..1 | display |  |
mae6.6 | Is the Adverse Medical event still ongoing? | 0..1 | choice |  | Options: 2 options
mae6.6_help | Indicator if the adverse event is still continuing or has been resolved. | 0..1 | display |  |
mae6.7 | Stop Date | 0..1 | date |  | Enable When: mae6.6 = No (expandedYes-NoIndicator#N)
mae6.7_help | Date that the event resolved | 0..1 | display |  |
mae6.8 | Was the event expected? | 0..1 | choice |  | Options: 2 options
mae6.8_help | Indicator that Adverse Medical Event was expected or not expected. | 0..1 | display |  |
mae6.11 | Seriousness | 0..1 | group |  | Enable When: mae6.10 = Serious (AdverseEventSeriousness#serious)
mae6.11.1 | Seriousness | 0..1 | choice |  | Enable When: mae6.10 = Serious (AdverseEventSeriousness#serious) Options: 7 options
mae6.11.1_help | 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 | 0..1 | display |  |
mae6.11.2 | Other-specify | 0..1 | text |  | Enable When: mae6.11.1 = Other (Temporary Codes#Other)
mae6.11.2_help | Describe other serious consequences or other medically important condition | 0..1 | display |  |
mae6.12 | What is the date Adverse Medical Event became serious? | 0..1 | date |  | Enable When: mae6.10 = Serious (AdverseEventSeriousness#serious)
mae6.12_help | Date adverse event was deemed as serious | 0..1 | display |  |
mae6.13 | Outcome of Adverse Medical Event | 0..1 | choice |  | Options: 6 options
mae6.13_help | Participant's status after the adverse event | 0..1 | display |  |
mae6.14 | Was autopsy performed? | 0..1 | choice |  | Enable When: mae6.13 = Fatal (Temporary Codes#FATAL) Options: 3 options
mae6.14_help | Indicator if participant was autopsied | 0..1 | display |  |
mae6.15 | Relationship of Adverse Medical Event to Study Intervention | 0..1 | choice |  | Options: 6 options
mae6.16 | Rationale for relationship with study intervention | 0..1 | text |  |
mae6.16_help | 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. | 0..1 | display |  |
mae6.17 | If applicable, what are possible alternate causes of the Adverse Medical Event? | 0..1 | choice |  | Options: 6 options
mae6.17_help | Reason for possible alternative serious adverse event causes | 0..1 | display |  |
mae6.18 | Study Procedure-specify | 0..1 | text |  | Enable When: mae6.17 = Study Procedure (Temporary Codes#STDYPRO)
mae6.18_help | Study procedure associated with SAE | 0..1 | display |  |
mae6.19 | Pre-existing condition-specify | 0..1 | text |  | Enable When: mae6.17 = Pre-existing condition (Temporary Codes#PRE)
mae6.19_help | Pre-existing condition associated with SAE | 0..1 | display |  |
mae6.20 | Underlying disease-specify | 0..1 | text |  | Enable When: mae6.17 = Underlying disease (Temporary Codes#UNDERLYINGDIS)
mae6.20_help | Underlying disease associated with SAE | 0..1 | display |  |
mae6.21 | Concomittant medication-specify | 0..1 | text |  | Enable When: mae6.17 = Concomitant medication (Temporary Codes#CONCMITMED)
mae6.21_help | Concomitant medication associated with SAE | 0..1 | display |  |
mae6.22 | Other known or suspected cause-specify | 0..1 | text |  | Enable When: mae6.17 = Other known or suspected cause (Temporary Codes#OTHERCAUSE)
mae6.22_help | Description of other causal reason associated with SAE | 0..1 | display |  |
mae6.23 | Action Taken | 0..1 | group |  |
mae6.23.1 | Action Taken Regarding Study Intervention | 0..1 | choice |  | Options: 7 options
mae6.23.1_help | Changes to study intervention made after adverse event was detected | 0..1 | display |  |
mae6.24 | If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate? | 0..1 | choice |  | Options: 3 options
mae6.24_help | Adverse event diminished/abated after study intervention was discontinued, interrupted, or dose reduced (dechallenged) | 0..1 | display |  |
mae6.25 | If study intervention was restarted (rechallenge) did AE recur? | 0..1 | choice |  | Options: 3 options
mae6.25_help | Adverse event recurred when the study intervention was restarted | 0..1 | display |  |
mae6.50 | SAE Concomitant Medications, Treatments/Procedures and Tests | 0..1 | group |  | Enable When: mae6.10 = Serious (AdverseEventSeriousness#serious)
mae6.50.26 | Did the participant receive any relevant concomitant medications in response to the SAE? | 0..1 | choice |  | Enable When: mae6.10 = Serious (AdverseEventSeriousness#serious) Options: 2 options
mae6.50.28 | SAE Concomitant Medications | 0..* | group |  | Enable When: mae6.50.26 = Yes (expandedYes-NoIndicator#Y)
mae6.50.28.1 | Medication Name | 0..1 | string |  |
mae6.50.28.1_help | Name of concomitant medication given to participant in response to SAE | 0..1 | display |  |
mae6.50.28.2 | Indication | 0..1 | string |  |
mae6.50.28.2_help | Indication for giving the concomitant medication to participant | 0..1 | display |  |
mae6.50.28.3 | Start Date | 0..1 | date |  |
mae6.50.28.3_help | Start date for the concomitant medication given to participant | 0..1 | display |  |
mae6.50.28.4 | Stop Date | 0..1 | date |  |
mae6.50.28.4_help | Stop date for the concomitant medication given to the participant | 0..1 | display |  |
mae6.50.28.5 | Ongoing | 0..1 | choice |  | Options: 2 options
mae6.50.28.5_help | Is concomitant medication administration for participant ongoing? | 0..1 | display |  |
mae6.50.28_help | Concomitant medication associated with SAE | 0..1 | display |  |
mae6.50.29 | Did the participant receive any treatments/procedures in response to the SAE? | 0..1 | choice |  | Enable When: mae6.10 = Serious (AdverseEventSeriousness#serious) Options: 2 options
mae6.50.29_help | Treatments/procedures administered in response to SAE | 0..1 | display |  |
mae6.50.30 | SAE Treatments/Procedures | 0..* | group |  | Enable When: mae6.50.29 = Yes (expandedYes-NoIndicator#Y)
mae6.50.30.1 | Treatment/Procedure | 0..1 | string |  |
mae6.50.30.1_help | Name of SAE treatment/procedure participant received | 0..1 | display |  |
mae6.50.30.2 | Start Date | 0..1 | date |  |
mae6.50.30.2_help | Start date for SAE treatment/procedure participant received | 0..1 | display |  |
mae6.50.30.3 | Stop Date | 0..1 | date |  |
mae6.50.30.3_help | Stop date for SAE treatment/procedure participant received | 0..1 | display |  |
mae6.50.30.4 | Ongoing | 0..1 | choice |  | Options: 2 options
mae6.50.30.4_help | Is the SAE treatment/procedure for the participant ongoing | 0..1 | display |  |
mae6.50.30_help | SAE treatment/procedure participant received | 0..1 | display |  |
mae6.50.37 | Did the participant receive relevant laboratory or diagnostic tests in response to the SAE? | 0..1 | choice |  | Enable When: mae6.10 = Serious (AdverseEventSeriousness#serious) Options: 2 options
mae6.50.37_help | Were any laboratory or diagnostic tests administered to the participant in response to the SAE? | 0..1 | display |  |
mae6.50.38 | SAE Laboratory or Diagnostic Tests | 0..* | group |  | Enable When: mae6.50.37 = Yes (expandedYes-NoIndicator#Y)
mae6.50.38.1 | Lab/Diagnostic Test | 0..1 | string |  |
mae6.50.38.2 | Date | 0..1 | date |  |
mae6.50.38.3 | Result | 0..1 | string |  |
mae6.50.38.4 | Low Range | 0..1 | string |  |
mae6.50.38.5 | High Range | 0..1 | string |  |
mae6.50.38.6 | Comments | 0..1 | string |  |
mae6.50.38_help | Laboratory or diagnostic tests obtained in response to SAE | 0..1 | display |  |
mae6_help | 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. | 0..1 | display |  |
mae11 | Optional Attachments | 0..* | group |  |
mae11.1 | Describe the file that is being attached (optional) | 0..1 | string |  |
mae11.2 | Attachment | 0..1 | attachment |  |
mae11_help | Attachments related to the Adverse Event Report can be included here. | 0..1 | display |  |
ADMIN00 | Administrative Use Only | 0..1 | group |  |
ADMIN01 | Link ID prefix | 0..1 | string |  | Initial Value: string = mae
ADMIN02 | Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any | 0..1 | string |  | Initial Value: string = temporarily unavailable Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value`
ADMIN03 | ID of the Research Study FHIR Resource associated with the study Questionnaire Responses | 0..1 | string |  | Initial Value: string = temporarily unavailable Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value`
ADMIN04 | Questionnaire Response ID of the local considerations Questionnaire Response, if any | 0..1 | string |  |
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")