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")
The content of the Questionnaire Response transferred to this Questionnaire during form launch
The Initiate a Study Questionnaire Response content that will be used to pre-populate this Questionnaire
variable to store the incoming data from the launchContext extension for populate and other expressions
event happened at the lead PI site/coordinating center
%resource.descendants().where(linkId = 'mae4.1.7').answer.valueCoding.code
%resource.descendants().where(linkId = 'mae4.1.1').answer.value.display
%resource.descendants().where(linkId = 'mae4.9.1').answer.valueCoding.code
HL7 International - Biomedical Research and Regulation
%lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value
Short title of the study, the same title listed on the Informed Consent
%lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value
Number assigned by IRB; this number is the same as that on the Consent Form
%lookupInitiateStudy.descendants().where(linkId = 'in1.4').answer.valueCoding
Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)
%lookupInitiateStudy.descendants().where(linkId = 'in9.1').answer.valueCoding
Does this protocol require an FDA exemption?
Indicator for use of FDA regulated product
%lookupInitiateStudy.descendants().where(linkId = 'in9.2').answer.valueCoding
Is an IND or IDE being used in this study?
Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?
%lookupInitiateStudy.descendants().where(linkId = 'in9.4').answer.valueCoding
Select whether Investigational New Drug (IND) or Investigational Device Exemption (IDE):
%lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value
Did the Adverse Medical Event occur at the lead principal investigator site?
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.
%lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value
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).
%resource.repeat(item).where(linkId = 'ExternalDataFor_mae4.1.1').answer.value
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.
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.
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)
Name of organization/site where the event occurred
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.
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)
First or given name of the principal investigator at site where Adverse Medical Event occurred
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)
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)
Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
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)
Professional and Academic degrees of the principal investigator at site where Adverse Medical Event occurred
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)
10-digit phone number, including area code
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)
Principal Investigator at site where Adverse Medical Event occurred
Responsibility for Adverse Medical Event Reporting
If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be recording the Adverse Non-Medical Event?
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.
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) )
Name of organization/site which is recording the Adverse Medical event
Location where adverse event is recorded
Personnel completing the adverse medical event documentation at the lead or relying site
Participant identifier from study case report form
Select inches, feet, centimeters, meters
Native Hawaiian or Other Pacific Islander
Which Arm/Cohort/treatment group was the participant assigned to (if known)?
Patient's treatment strategy assignment, if known.
Participant dosed or received study agent
Did the participant receive the investigational agent? If answer is unknown due to blinding, select No Information.
investigational agent or placebo or blinded study
Were there any Protocol Deviations/Violations/Exceptions for this participant?
Indicator if adverse medical event occurred with protocol deviation, violation, exception
Describe the Protocol Deviations/Violations/Exceptions
Description of protocol deviations, violations, or exceptions that occurred for this participant
Initial: the first time that the adverse medical event is reported or Update: update on a previously reported adverse medical event
Date this adverse event was first recorded
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
Physician assessment using sponsor defined categories
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.
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.
Is the Adverse Medical event still ongoing?
Indicator if the adverse event is still continuing or has been resolved.
Indicator that Adverse Medical Event was expected or not expected.
Requires or prolongs inpatient hospitalization
Results in persistent or significant disability/incapacity
Requires intervention to prevent permanent impairment
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
Describe other serious consequences or other medically important condition
What is the date Adverse Medical Event became serious?
Date adverse event was deemed as serious
Participant's status after the adverse event
Relationship of Adverse Medical Event to Study Intervention
Rationale for relationship with study intervention
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.
If applicable, what are possible alternate causes of the Adverse Medical Event?
Reason for possible alternative serious adverse event causes
Pre-existing condition associated with SAE
Concomitant medication associated with SAE
Description of other causal reason associated with SAE
Action Taken Regarding Study Intervention
Product dose or frequency of use reduced
Product dose or frequency of use increased
Product dose or frequency of use not changed
Changes to study intervention made after adverse event was detected
If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate?
Adverse event diminished/abated after study intervention was discontinued, interrupted, or dose reduced (dechallenged)
If study intervention was restarted (rechallenge) did AE recur?
Adverse event recurred when the study intervention was restarted
SAE Concomitant Medications, Treatments/Procedures and Tests
Did the participant receive any relevant concomitant medications in response to the SAE?
Name of concomitant medication given to participant in response to SAE
Indication for giving the concomitant medication to participant
Start date for the concomitant medication given to participant
Stop date for the concomitant medication given to the participant
Is concomitant medication administration for participant ongoing?
Did the participant receive any treatments/procedures in response to the SAE?
Treatments/procedures administered in response to SAE
Name of SAE treatment/procedure participant received
Start date for SAE treatment/procedure participant received
Stop date for SAE treatment/procedure participant received
Is the SAE treatment/procedure for the participant ongoing
SAE treatment/procedure participant received
Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?
Were any laboratory or diagnostic tests administered to the participant in response to the SAE?
Laboratory or diagnostic tests obtained in response to SAE
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.
Describe the file that is being attached (optional)
Attachments related to the Adverse Event Report can be included here.
%lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value
Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
%lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value
ID of the Research Study FHIR Resource associated with the study Questionnaire Responses
Questionnaire Response ID of the local considerations Questionnaire Response, if any