Generated Narrative

questionnaire: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire

status: completed

authored: Jul 23, 2021 4:36:24 PM

item

linkId: mae1

text: RESEARCH STUDY

item

linkId: mae1.1

text: Study Title

item

linkId: mae1.2

text: IRB Protocol Number

item

linkId: mae1.3

text: Study Type

item

linkId: mae1.4

text: Does this protocol require an FDA exemption?

item

linkId: mae1.5

text: Is an IND or IDE being used in this study?

item

linkId: mae2

text: Site Principal Investigator

item

linkId: mae2.1

text: First Name

item

linkId: mae2.2

text: Last Name

item

linkId: mae2.6

text: Degree(s)

item

linkId: mae2.3

text: Phone

item

linkId: mae2.4

text: Email

item

linkId: mae3

text: Primary Contact

item

linkId: mae3.1

text: First Name

item

linkId: mae3.2

text: Last Name

item

linkId: mae3.3

text: Phone

item

linkId: mae3.4

text: Email

item

linkId: mae4

text: Site/Organization

item

linkId: mae4.1

text: Name of organization/site where the event occurred

item

linkId: mae4.2

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

item

linkId: mae5

text: Participant Information

item

linkId: mae5.1

text: Patient ID

item

linkId: mae5.2

text: Age

item

linkId: mae5.3

text: Birth Sex

item

linkId: mae5.4

text: Weight

item

linkId: mae5.5

text: Height

item

linkId: mae5.6

text: Ethnicity

item

linkId: mae5.7

text: Race

item

linkId: mae5.8

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

item

linkId: mae5.9

text: Participant dosed or received study agent

item

linkId: mae5.11

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

item

linkId: mae6

text: Adverse Medical Event Information

item

linkId: mae6.1

text: Submission Type

item

linkId: mae6.2

text: Start Date

item

linkId: mae6.3

text: Reported Date

item

linkId: mae6.4

text: Recorded Date

item

linkId: mae6.5a

text: Narrative of the Adverse Event:

item

linkId: mae6.5b

text: Medical Description of Adverse Event

item

linkId: mae6.6

text: Is the Adverse Medical event still ongoing?

item

linkId: mae6.7

text: Stop Date

item

linkId: mae6.8

text: Was the event expected?

item

linkId: mae6.9

text: Severity

item

linkId: mae6.10

text: Is the Adverse Medical Event Serious?

item

linkId: mae6.11

text: Seriousness

item

linkId: mae6.12

text: What is the date Adverse Medical Event became serious?

item

linkId: mae6.13

text: Outcome of Adverse Medical Event

item

linkId: mae6.15

text: Relationship of Adverse Medical Event to Study Intervention

item

linkId: mae6.16

text: Rationale for relationship with study intervention

item

linkId: mae6.23

text: Action Taken Regarding Study Intervention

item

linkId: mae6.24

text: If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did AE diminish/abate?

item

linkId: mae6.25

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

item

linkId: mae6.26

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

item

linkId: mae6.27

text: SAE Concomitant Medications

item

linkId: mae6.29

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

item

linkId: mae7

text: Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?

Answers

-	Value[x]
*	Yes

item

linkId: mae8

text: SAE Laboratory or Diagnostic Tests

item

linkId: mae8.1

text: Lab/Diagnostic Test

item

linkId: mae8.2

text: Date

item

linkId: mae8.3

text: Result

item

linkId: mae8.4

text: Low Range

item

linkId: mae8.5

text: High Range

item

linkId: mae8.6

text: Comments

item

linkId: ADMIN00

text: Administrative Use Only

item

linkId: ADMIN01

text: Link ID prefix