Generated Narrative

questionnaire: https://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevents-questionnaire

status: completed

authored: Jul 23, 2021 2:37:12 AM

item

linkId: nme1

text: Research Study

item

linkId: nme1.1

text: Study Title:

item

linkId: nme1.3

text: IRB Protocol Number:

item

linkId: nme1.4

text: Status:

item

linkId: nme2a

text: Site/Organization

item

linkId: nme2a.1

text: Organization/site where the Adverse Non-Medical Event occurred

item

linkId: nme2a.2

text: Organization/site which is recording the Adverse Non-Medical Event

item

linkId: nme2b

text: Site Principal Investigator for the site where Adverse Non-Medical Event occurred

item

linkId: nme2b.1

text: First Name

item

linkId: nme2b.4

text: Last Name

item

linkId: nme2b.5

text: Suffix

item

linkId: nme2b.6

text: Degree(s)

item

linkId: nme2b.2

text: Phone:

item

linkId: nme2b.3

text: Email:

item

linkId: nme3

text: Report

item

linkId: nme3.1

text: Report Date:

item

linkId: nme3.2

text: Report Status

item

linkId: nme3.4

text: New information resulted in unexpected change in risks of the research.

item

linkId: nme3.5

text: New or increased risk

item

linkId: nme3.6

text: Unanticipated Problem Involving Risk to Participants or Others

item

linkId: nme3.7

text: Unanticipated Problem

item

linkId: nme3.8

text: Protocol Deviation (accidental or unintentional)

item

linkId: nme3.9

text: Protocol Deviation (Non-Compliance)

item

linkId: nme3.10

text: A breach of Confidentiality

item

linkId: nme3.11

text: Breach of Confidentiality

item

linkId: nme3.12

text: Incarceration of a participant in a protocol not approved to enroll prisoners

item

linkId: nme3.13

text: Incarceration

item

linkId: nme3.14

text: Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team.

item

linkId: nme3.15

text: Participant Complaint

item

linkId: nme3.16

text: Other Type of Adverse Non-Medical Event

item

linkId: nme3.17

text: Other Type

item

linkId: nme4

text: Reporting

item

linkId: nme4.1

text: Was the Sponsor notified?

item

linkId: nme4.2

text: Notification date:

item

linkId: nme4.3

text: Was the IRB notified?

item

linkId: nme4.4

text: Notification date:

item

linkId: nme4.5

text: Were any Other Parties notified?

item

linkId: nme4.6

text: Please list other notified parties

item

linkId: nme5

text: Corrective and Preventative Action Plan

item

linkId: nme5.1

text: Was a Root Cause analysis performed?

item

linkId: nme5.2a

text: If yes, provide determination:

item

linkId: nme5.3

text: Was Corrective Action implemented?

item

linkId: nme5.4

text: If Corrective Action was implemented or is pending, provide a summary:

item

linkId: nme5.5

text: Was Preventitive Action implemented?

item

linkId: nme5.6

text: If Preventitive Action was implemented or is pending, provide a summary:

item

linkId: nme6

text: Study Protocol and Informed Consent

item

linkId: nme6.1a

text: Are changes required to the Study Protocol as a result of this report?

item

linkId: nme6.3a

text: Are changes required to the Informed Consent as a result of this report?

item

linkId: nme6.5

text: Are notifications or re-consenting of participants required as a result of this change?

item

linkId: nme6.6

text: If yes, detail how the notification and/or re-consent will occur:

item

linkId: ADMIN00

text: Administrative Use Only

item

linkId: ADMIN01

text: Link ID prefix