Institutional Review Board
Unanticipated Problem Report
PI Name:
IRB #:
Title of Protocol:
Definitions
Unanticipated problem - Any event or information that (1) was unforeseen and (2) indicates that the research
procedures may have caused harm to participants or others or indicates that participants or others are at increased risk
of harm. The harm does not have to be a direct harm to be reportable. The harm, as assessed by the PI or monitoring
agent, has presented increased risk (e.g., losing a laptop with subject data.) Additionally, the harm doesn't have to be the
harm to subjects it could involve risk to others (researchers, technicians, bystanders, the public, etc.)
Note: non-medical events (e.g., breach of confidentiality, emotional breakdown, loss of insurance, etc.) if unanticipated
or not specified in the approved protocol or consent – is also reportable to the IRB.
Unanticipated/Unexpected- An event is unanticipated or unexpected when its specificity or severity is not consistent with
the current investigator brochure, protocol, consent form, package insert or label; or unanticipated in its frequency,
severity, or specificity.*
Harm is anything that has negative effect on the welfare of subjects; the nature of the harm may be social,
behavioral, psychological, physical, economical, legal, and reputational.
Related – An event is related to a research procedures if in the opinion of the principal investigator, it was more likely
than not to be caused by the research procedures or if it is more likely that not that the event affects the rights and welfare
of current participants.
Adverse Event – Is any physical, psychological or social harm to subjects during the course of research.
*Note: If an anticipated event has changed in specificity or severity and is no longer consistent with the current protocol or consent form
it is now an UNANTICIPATED EVENT.
1. Study Status
Indicate where this study is taking
place
This is a follow-up report
This study is open to enrollment
Protocol Involves:
Multi-Site;
But event occurred here
Event occurred off-site
Princeton only
Yes; original report date was:
No; Date Event occurred:
Yes
No
Interview procedures
Investigator Initiated
Investigational Drug
Investigational Device
IND#
IDE#
Unanticipated Event Report 5-2013
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2. Type of Event
Any of the following must report to the IRB as soon as possible, but in all cases within 5 working days:
Adverse event which in the opinion of the principal investigator is both unexpected and related
An unanticipated event related to the research that exposes individuals other than the research
participants (e.g., investigators, research assistants, students, the public, etc.) to potential risk
Information that indicates a change to the risks or potential benefits of the research. For example:
• an interim analysis or safety monitoring report indicates that frequency or magnitude of harms or
benefits may be different than initially presented to the IRB
• a paper is published from another study that shows that the risks or potential benefits of your
A breach of confidentiality
Incarceration of a participant in a protocol not approved to enroll prisoners
Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a
research participant
Complaint of a participant when the complaint indicates unexpected risks or cannot be resolved by the
research team
Protocol violation (meaning an accidental or unintentional change to the IRB approved protocol) that
harmed participants or others or that indicates participants or others may be at increased risk of harm
Event that requires prompt reporting to the sponsor
Sponsor imposed suspension for risk
3. Event Information
Briefly describe the circumstances of this event
State whether the event was anticipated and
describe
Yes
No
Other; describe:
Date of the Event
Intensity
mild
Severe
Unknown
Was event study-related?
How long did the event last
Currently enrolled volunteers will be notified of this
event
Yes; describe method of notification:
No
Previously enrolled volunteers will be notified of this
event
Yes; describe method of notification:
No
P.I.’s statement of this Event in relation to the study
Event Information (Complete this section only if you are reporting an Anticipated (Expected) Event that has
changed and requires updating see Definition section above)
The risk of this event is currently outlined in the study’s
consent form
Yes
No
Unanticipated Problem Report 2013
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Yes
No
The risk of this event is currently outlined in the study’s
approved protocol
If you answered “yes” to either question above, explain
why you are reporting this event to the IRB
Explain any changes you will be making to the
protocol, consent or IRB application
Note: Any Changes MUST be submitted to the IRB on a Request for Amendment Form
4. Research Participant Information
For purposes of this form, the term “subjects” should be read to refer to all participants, patients, etc.
Yes
No
This event involved a healthy volunteer
Participant age ( if age is > 88, do not list age
just state ‘89 or above’)
Participant gender
Male
Female
Participant Status
Pre-screened
Enrolled
Yes
No:
This event involved a healthy participant
5. Attachments
This event has prompted a change to the Informed
Consent(s)/Assent(s):
This event has prompted a change to the Protocol
This event has prompted an update in the IRB application
Yes Attached version date is:
No
Yes Attached version date is:
No
Yes Attached version date is:
No
If you answered “no” to any of the question above, explain
why you are reporting this event to the IRB
Note: Any Changes MUST be submitted to the IRB on a Request for
Modification Request form
PI’s Signature
Date
Print Name
Signature
I ATTEST THAT THE INFORMATION CONTAINED HEREIN IS A TRUE AND ACCURATE
REPRESENTATION OF MY ONGOING STUDY AND THE EVENTS THAT OCCURRED.
(IRB Use Only)
Status
Acknowledged
Full Board
Reviewer
Review Date
Unanticipated Problem Report 2013
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