Generated Narrative

questionnaire: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire

status: completed

authored: Jul 27, 2021 3:22:08 PM

item

linkId: cr1

text: Research Study

item

linkId: cr1.1

text: Study Title

item

linkId: cr1.2

text: IRB Protocol Number

item

linkId: cr1.3

text: Enrollment Status:

item

linkId: cr1.4

text: Intervention Status:

item

linkId: cr1.5

text: Study Status:

item

linkId: cr1.6

text: Funding Source(check all that are applicable):

item

linkId: cr2

text: Site Principal Investigator

item

linkId: cr2.1

text: First Name

item

linkId: cr2.4

text: Last Name

item

linkId: cr2.6

text: Degree(s)

item

linkId: cr2.2

text: Phone

item

linkId: cr2.3

text: Email:

item

linkId: cr3a

text: Report Type

item

linkId: cr3a.1

text: Is this an initial report?

item

linkId: cr3

text: Accrual of Participants

item

linkId: cr3.1

text: Provide counts for the following:

item

linkId: cr3.2

text: Vulnerable Populations

item

linkId: cr4

text: Study Report

item

linkId: cr4.5

text: Since your last report (or since the study inception for an initial report):

item

linkId: cr5

text: Adverse Events

item

linkId: cr5.1

text: Have there been any internal or local adverse events in the research?

item

linkId: cr5.3

text: Have any protocol deviations or violations occurred in this study?

item

linkId: cr6

text: Conflict of Interest

item

linkId: cr6.1

text: Has there been a change in the financial disclosure status of the Principal Investigator or other members of the Research Staff that has not been reported to the IRB?

item

linkId: ADMIN00

text: Administrative Use Only

item

linkId: ADMIN01

text: Link ID prefix

item

linkId: ADMIN02

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

item

linkId: ADMIN03

text: ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any