Questionnaire-sirb-adverse-event-questionnaire-populate

Sourcehl7.fhir.us.sirb#current:Single Institutional Review Board (sIRB) Implementation Guide (v4.0.1)
resourceTypeQuestionnaire
idsirb-adverse-event-questionnaire-populate
canonicalhttp://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate
version1.0.0
statusdraft
publisherHL7 International - BR&R Work Group
nameAE_Questionnaire
titleAdverse Medical Event Questionnaire
date2023-03-29T06:17:19+00:00
jurisdictionsus
Usages(none)

Research Study

  • linkId: mae1

Study Title

  • linkId: mae1.1

Short title of the study, the same title listed on the Informed Consent

  • linkId: mae1.1_help

IRB Protocol Number

  • linkId: mae1.2

Number assigned by IRB; this number is the same as that on the Consent Form

  • linkId: mae1.2_help

Study Type

Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)

  • linkId: mae1.3_help

Does this protocol require an FDA exemption?

Indicator for use of FDA regulated product

  • linkId: mae1.4_help

Is an IND or IDE being used in this study?

Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?

  • linkId: mae1.5_help

Select whether Investigational New Drug (IND) or Investigational Device Exemption (IDE):

IND/IDE Number

  • linkId: mae1.7
  • Enable When: todo

Organization/Site

  • linkId: mae4

Where Adverse Medical Event Occurred

  • linkId: mae4.1

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.

  • linkId: mae4.1.7_help

External Data For linkId mae4.1.1

  • Flags: icon
  • linkId: ExternalDataFor_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.

  • linkId: mae4.1.1
  • Enable When: todo

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.

  • linkId: mae4.1.1_help

Name of organization/site where the event occurred

  • linkId: mae4.1.2
  • Enable When: todo

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.

  • linkId: mae4.1_help

Site Principal Investigator

  • linkId: mae4.7
  • Enable When: todo

First Name

  • linkId: mae4.7.1

First or given name of the principal investigator at site where Adverse Medical Event occurred

  • linkId: mae4.7.1_help

Last Name

  • linkId: mae4.7.2

Surname or family name

  • linkId: mae4.7.2_help

Suffix

  • linkId: mae4.7.5

Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.

  • linkId: mae4.7.5_help

Degree(s)

  • linkId: mae4.7.6

Professional and Academic degrees of the principal investigator at site where Adverse Medical Event occurred

  • linkId: mae4.7.6_help

Phone

  • linkId: mae4.7.3

10-digit phone number, including area code

  • linkId: mae4.7.3_help

Email

  • linkId: mae4.7.4

Principal Investigator at site where Adverse Medical Event occurred

  • linkId: mae4.7_help

Responsibility for Adverse Medical Event Reporting

  • linkId: mae4.9
  • Enable When: todo

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.

  • linkId: mae4.9.1_help

Name of organization/site which is recording the Adverse Medical event

  • linkId: mae4.9.2
  • Enable When: todo

Location where adverse event is recorded

  • linkId: mae4.9.2_help

Primary Contact

  • linkId: mae3

Personnel completing the adverse medical event documentation at the lead or relying site

  • linkId: mae3_help

First Name

  • linkId: mae3.1

First or given name

  • linkId: mae3.1_help

Last Name

  • linkId: mae3.2

Surname or family name

  • linkId: mae3.2_help

Phone

  • linkId: mae3.3

10-digit phone number, including area code

  • linkId: mae3.3_help

Email

  • linkId: mae3.4

Participant Information

  • linkId: mae5

Patient ID

  • linkId: mae5.1

Participant identifier from study case report form

  • linkId: mae5.1_help

Age

  • linkId: mae5.2

Birth Sex

Weight

  • linkId: mae5.4

Select pounds or kilograms

  • linkId: mae5.4_help

Height

  • linkId: mae5.5

Select inches, feet, centimeters, meters

  • linkId: mae5.5_help

Ethnicity

Race

Which Arm/Cohort/treatment group was the participant assigned to (if known)?

  • linkId: mae5.8

Patient's treatment strategy assignment, if known.

  • linkId: mae5.8_help

Participant dosed or received study agent

Did the participant receive the investigational agent? If answer is unknown due to blinding, select No Information.

  • linkId: mae5.9_help

What study agent was received:

investigational agent or placebo or blinded study

  • linkId: mae5.10_help

Were there any Protocol Deviations/Violations/Exceptions for this participant?

Indicator if adverse medical event occurred with protocol deviation, violation, exception

  • linkId: mae5.11_help

Describe the Protocol Deviations/Violations/Exceptions

  • linkId: mae5.12
  • Enable When: todo

Description of protocol deviations, violations, or exceptions that occurred for this participant

  • linkId: mae5.12_help

Adverse Medical Event Information

  • linkId: mae6

Submission Type

Initial: the first time that the adverse medical event is reported or Update: update on a previously reported adverse medical event

  • linkId: mae6.1_help

Start Date

  • linkId: mae6.2

Date adverse event started

  • linkId: mae6.2_help

Reported Date

  • linkId: mae6.3

Date of this report

  • linkId: mae6.3_help

Recorded Date

  • linkId: mae6.4

Date this adverse event was first recorded

  • linkId: mae6.4_help

Is the Adverse Medical Event Serious?

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

  • linkId: mae6.10_help

Severity

Physician assessment using sponsor defined categories

  • linkId: mae6.9_help

Narrative of the Adverse Event:

  • linkId: mae6.40
  • Enable When: todo

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.

  • linkId: mae6.40_help

Medical Description of Adverse Event

  • linkId: mae6.5

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.

  • linkId: mae6.5_help

Is the Adverse Medical event still ongoing?

Indicator if the adverse event is still continuing or has been resolved.

  • linkId: mae6.6_help

Stop Date

  • linkId: mae6.7
  • Enable When: todo

Date that the event resolved

  • linkId: mae6.7_help

Was the event expected?

Indicator that Adverse Medical Event was expected or not expected.

  • linkId: mae6.8_help

Seriousness

  • linkId: mae6.11
  • Enable When: todo

Seriousness

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

  • linkId: mae6.11.1_help

Other-specify

  • linkId: mae6.11.2
  • Enable When: todo

Describe other serious consequences or other medically important condition

  • linkId: mae6.11.2_help

What is the date Adverse Medical Event became serious?

  • linkId: mae6.12
  • Enable When: todo

Date adverse event was deemed as serious

  • linkId: mae6.12_help

Outcome of Adverse Medical Event

Participant's status after the adverse event

  • linkId: mae6.13_help

Was autopsy performed?

Indicator if participant was autopsied

  • linkId: mae6.14_help

Relationship of Adverse Medical Event to Study Intervention

Rationale for relationship with study intervention

  • linkId: mae6.16

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.

  • linkId: mae6.16_help

If applicable, what are possible alternate causes of the Adverse Medical Event?

Reason for possible alternative serious adverse event causes

  • linkId: mae6.17_help

Study Procedure-specify

  • linkId: mae6.18
  • Enable When: todo

Study procedure associated with SAE

  • linkId: mae6.18_help

Pre-existing condition-specify

  • linkId: mae6.19
  • Enable When: todo

Pre-existing condition associated with SAE

  • linkId: mae6.19_help

Underlying disease-specify

  • linkId: mae6.20
  • Enable When: todo

Underlying disease associated with SAE

  • linkId: mae6.20_help

Concomittant medication-specify

  • linkId: mae6.21
  • Enable When: todo

Concomitant medication associated with SAE

  • linkId: mae6.21_help

Other known or suspected cause-specify

  • linkId: mae6.22
  • Enable When: todo

Description of other causal reason associated with SAE

  • linkId: mae6.22_help

Action Taken

  • linkId: mae6.23

Action Taken Regarding Study Intervention

Changes to study intervention made after adverse event was detected

  • linkId: mae6.23.1_help

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)

  • linkId: mae6.24_help

If study intervention was restarted (rechallenge) did AE recur?

Adverse event recurred when the study intervention was restarted

  • linkId: mae6.25_help

SAE Concomitant Medications, Treatments/Procedures and Tests

  • linkId: mae6.50
  • Enable When: todo

Did the participant receive any relevant concomitant medications in response to the SAE?

SAE Concomitant Medications

  • linkId: mae6.50.28
  • Enable When: todo

Medication Name

  • linkId: mae6.50.28.1

Name of concomitant medication given to participant in response to SAE

  • linkId: mae6.50.28.1_help

Indication

  • linkId: mae6.50.28.2

Indication for giving the concomitant medication to participant

  • linkId: mae6.50.28.2_help

Start Date

  • linkId: mae6.50.28.3

Start date for the concomitant medication given to participant

  • linkId: mae6.50.28.3_help

Stop Date

  • linkId: mae6.50.28.4

Stop date for the concomitant medication given to the participant

  • linkId: mae6.50.28.4_help

Ongoing

Is concomitant medication administration for participant ongoing?

  • linkId: mae6.50.28.5_help

Concomitant medication associated with SAE

  • linkId: mae6.50.28_help

Did the participant receive any treatments/procedures in response to the SAE?

Treatments/procedures administered in response to SAE

  • linkId: mae6.50.29_help

SAE Treatments/Procedures

  • linkId: mae6.50.30
  • Enable When: todo

Treatment/Procedure

  • linkId: mae6.50.30.1

Name of SAE treatment/procedure participant received

  • linkId: mae6.50.30.1_help

Start Date

  • linkId: mae6.50.30.2

Start date for SAE treatment/procedure participant received

  • linkId: mae6.50.30.2_help

Stop Date

  • linkId: mae6.50.30.3

Stop date for SAE treatment/procedure participant received

  • linkId: mae6.50.30.3_help

Ongoing

Is the SAE treatment/procedure for the participant ongoing

  • linkId: mae6.50.30.4_help

SAE treatment/procedure participant received

  • linkId: mae6.50.30_help

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?

  • linkId: mae6.50.37_help

SAE Laboratory or Diagnostic Tests

  • linkId: mae6.50.38
  • Enable When: todo

Lab/Diagnostic Test

  • linkId: mae6.50.38.1

Date

  • linkId: mae6.50.38.2

Result

  • linkId: mae6.50.38.3

Low Range

  • linkId: mae6.50.38.4

High Range

  • linkId: mae6.50.38.5

Comments

  • linkId: mae6.50.38.6

Laboratory or diagnostic tests obtained in response to SAE

  • linkId: mae6.50.38_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.

  • linkId: mae6_help

Optional Attachments

  • linkId: mae11

Describe the file that is being attached (optional)

  • linkId: mae11.1

Attachment

  • linkId: mae11.2

Attachments related to the Adverse Event Report can be included here.

  • linkId: mae11_help

Administrative Use Only

  • Flags: icon
  • linkId: ADMIN00

Link ID prefix

  • Flags: icon
  • linkId: ADMIN01
  • Initial Values: mae

Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any

  • Flags: icon
  • linkId: ADMIN02
  • Initial Values: temporarily unavailable

ID of the Research Study FHIR Resource associated with the study Questionnaire Responses

  • Flags: icon
  • linkId: ADMIN03
  • Initial Values: temporarily unavailable

Questionnaire Response ID of the local considerations Questionnaire Response, if any

  • Flags: icon
  • linkId: ADMIN04

Produced 06 Apr 2023