INSTITUTIONAL REVIEW BOARD

UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS (UPIRSO) FORM

Use this form to report a single local/non-local event. Please answer each question as indicated, using language that can be understood by scientific and non-scientific members. If applicable, include supporting documentation with your submission.

If you have questions about how to answer any particular question, please refer to the GHS-IRB UPIRSO Reporting Guidelines in the IRB Standard Operating Procedures. This can be accessed via the Genesis Research website.

Helpful hint – Use the UP and DOWN arrow keys on your keyboard to navigate between the entry fields.

Criteria for Reporting to the GHS-IRB

A.UPIRSOs, Serious Adverse Events (SAEs), Unanticipated Adverse Device Effects

In order to be reportable, ALL of the following criteria must be YES: / YES / NO*
Unexpected in terms of nature, severity, or frequency
An event is unexpected if it is not consistent with the following:
a)The known or foreseeable risk of adverse events associated with the research as stated in the protocol, investigator’s brochure, current IRB-approved informed consent or other relevant sources of information; or
b)The expected natural progression of an underlying disease, disorder or condition of the subject experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse event.
Related or possibly related to participation in the research
The GHS-IRB defines possibly related as a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research.
Event suggests that the research places subjects or others at a greater risk of harmthan previously known or recognized
Including physical, psychological, economic, or social harm

*If you answered NOto anyof the above, the event is NOT reportable to the GHS-IRB.

Note –A summary of ALL adverse events should be reported to the IRB at the time of continuing review.

B.Protocol Deviations

In order to be reportable, ONE(1)of the following criteria must be YES: / YES / NO*
Deviation adversely affects the rights, safety or welfare of the subjects; or
Deviation significantly adversely impacts the integrity of the research data

*If you answered NOto both, the protocol deviation is NOT reportable to the GHS-IRB.

UPIRSOs that meet the definition of a serious adverse event (SAE) must be reported to the IRB within one (1) week of the Investigator’sknowledge of the event.

All other UPIRSOs (those that don’t meet the definition of anSAE) must be reported within two (2) weeks of the Investigator’sknowledge of the event.

Updated 11/3/16 sc/jl; rev. 12/28/16 jl; rev. 03/10/17 sc/jlPage 1 of 4

INSTITUTIONAL REVIEW BOARD

UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS (UPIRSO) FORM

1.Complete Project Title

Enter the complete project title here.

  1. Principal Investigator
  1. List the Purpose and Objectives of the Research as Stated in the Protocol

4.Event Type

Choose event type from drop down.

5.Location

Choose location from drop down.

  1. Report Type

Choose report type from drop down.

  1. Reporting Date
  1. Date of the Event or Action Letter
  1. Date of the Investigator's Knowledge of the Event

Note – ONLYthose non-local adverse events and unanticipated problems identified by the monitoring entity to meet the definition of an UPIRSO should be reported to the GHS-IRB. A DSMB (or similar) report should be included for these non-local events.

  1. Provide a detailed description of the adverse event, incident or experience, including interventions and outcomes.

11.Select the applicable underlined event below and complete the section in its entirety.

UPIRSO - Single Event - Refer to Section A of the application (page 1) for definitions of “unexpected” and “possibly related”

a)How is this single eventunexpected in terms of nature, severity or frequency?

Explain how this event is unexpected here.

b)This single event is: (select one)

Relatedto the research

If selected, you must explain how this event is related to the research here.

Possibly relatedto the research

If selected, you must explain how this event is possibly related to the research here.

c)How does this single event suggest that the research places subjects or others at a greater risk of harm?Including physical, psychological, economic, or social harm

Explain how this event suggests greater risk to subjects or others here.

UPIRSO - Compilation of Evidence(e.g., action letters examining evidence from multiple clinical trials)

a)List the evidencefor why the event meets the definition of an UPIRSO.

List the evidence or reasoning given in the action letter here.

Protocol Deviation(select all that apply)

Adversely affects the rights, safety or welfare of the subjects

If selected, you must explain how this deviation affects the rights, safety, or welfare of the subjects here.

Significantly adversely impacts the integrity of the research data

If selected, you must explain how this deviation adversely impacts the integrity of the research data here.

  1. What actions have you (or the sponsor) taken to protect study subjects or others?
  1. What actions do you (or the sponsor) recommend to protect study subjects or others in the future and to prevent a reoccurrence of this problem?
  1. Describe your plan to notify currently enrolled individuals of this event?
  1. This event has been reported to: (check all that apply)

Updated 11/3/16 sc/jl; rev. 12/28/16 jl; rev. 03/10/17 sc/jlPage 1 of 4

INSTITUTIONAL REVIEW BOARD

UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS (UPIRSO) FORM

Data Safety Monitoring Board

National Institutes of Health

Office for Human Research Protections

Sponsor

US Food and Drug Administration

Other - Explain other here.

Updated 11/3/16 sc/jl; rev. 12/28/16 jl; rev. 03/10/17 sc/jlPage 1 of 4

INSTITUTIONAL REVIEW BOARD

UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS (UPIRSO) FORM

Note - Any amendments to the protocol or informed consent form(s) must be submitted promptly to the GHS-IRB using the Amendment Application

Principal Investigator Assurance Statement

My electronic signature that will accompany the submission of this UPIRSO form and any supporting documentation to the Genesis Health System Institutional Review Board certifies that the details provided on this report form are a complete and accurate description of the problem/event.

Updated 11/3/16 sc/jl; rev. 12/28/16 jl; rev. 03/10/17 sc/jlPage 1 of 4