Package | hl7.fhir.us.sirb |
Type | Questionnaire |
Id | Id |
FHIR Version | R4 |
Source | http://hl7.org/fhir/us/sirb/https://build.fhir.org/ig/HL7/fhir-sirb/Questionnaire-sirb-adverse-event-questionnaire-populate.html |
Url | http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate |
Version | 1.0.0 |
Status | draft |
Date | 2023-04-24T20:03:27+00:00 |
Name | AE_Questionnaire |
Title | Adverse Medical Event Questionnaire |
Experimental | False |
Realm | us |
Authority | hl7 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
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:
| |
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:
| |
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:
| |
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:
| |
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:
| |
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:
| |
mae1.7 | IND/IDE Number | 0..1 | string | Enable When: mae1.5 = Yes (expandedYes-NoIndicator#Y) Expressions:
| |
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:
| |
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:
| |
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:
| |
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:
| |
mae4.7.2_help | Surname or family name | 0..1 | display | ||
mae4.7.5 | Suffix | 0..1 | string | Expressions:
| |
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:
| |
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:
| |
mae4.7.3_help | 10-digit phone number, including area code | 0..1 | display | ||
mae4.7.4 | 0..1 | string | Expressions:
| ||
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: Expressions:
| |
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 | 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: 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 | |