Institutional Review Board
Human Research Protection Program
1 Park Avenue | 6th Floor | New York, NY 10016
http://irb.med.nyu.edu
Reportable Event Form
When to Use this Form
This form should be used to submit a reportable event to the IRB. Reportable Events are defined as events
that are unanticipated and may cause risk of harm to the subject or others.
There are many types of events that can fall under this requirement. In fact the most commonly known event –
an adverse drug or device reaction – make up only a small portion of IRB reportable events.
An event can be an adverse drug or device reaction, a deviation from the protocol that caused harm to a
subject or a violation that was intended to eliminate apparent or immediate harm to the subject. However, there
are other events that the IRB needs to know about. Other types of events that should be reported to the IRB:
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Incarceration of an enrolled subject when your study was not approved to include prisoners,
An unresolved subject complaint that indicates a potential increase or unexpected risk
New information that presents a change to the risks or potential benefits.
A deviation or violation from the IRB approved protocol
Submission Instructions
Our website provides full instructions on submitting applications to the IRB: http://irb.med.nyu.edu/esubmission
Please contact the IRB office at 212 263-4110 with any questions.
Definitions
Unanticipated
An event is unanticipated y 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*.
*Note: If an anticipated event has changed in specificity or severity and is no longer consistent with the current investigator’s brochure,
protocol or consent form it is now an UNANTICIPATED EVENT.
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.
Harmful
Caused harm to participants or others, or placed them 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, imprisonment etc.). if unanticipated would also be reportable to the IRB.
Ad verse Event
Any physical, psychological or social harm to subjects during the course of research.
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Reportable Event Form
NYU School of Medicine IRB HRPP
Is this Event Reportable?
Note that all sections of this form may not be applicable to your event. It is important that you carefully read through the
section titled Type of Event.
Reportable Events
Is the event you would like to report
RELATED, UNANTICIPATED OR
HARMFUL?
Adverse Events
Is this adverse event, in the opinion of the
principal investigator, RELATED,
UNANTICIPATED AND HARMFUL?
Yes; Complete this form
No; Continue to answer below – if you check any one of the boxes
below, you need to complete this form
event is a deviation or violation of your IRB approved Protocol and
the event is serious, harmful or serious and continued non
compliance
event is a subject complaint that cannot be resolved
event is an incarceration of a subject and your study is not IRB
approved to include prisoners
Yes; Continue filling out this form
No; Stop. You do not need to complete this form
Administrative Information
Study#
Study Title
Department
Role
Date of Submission
Division
Name
Email
Phone
Fax
Principal Investigator
Contact Person
Indicate where this study is
taking place
This is a follow-up report
This study is open to
enrollment at NYU
Protocol Involves
Multi-Site;
event occurred here
event occurred off-site
NYU SoM/MC only
Yes; original report date was:
No; Date Event occurred:
Yes
No
Investigational Drug; IND#
Investigational Device; IDE#
Investigator Initiated
Type of Event
Unanticipated Problem
check all that apply
event has changed in severity or specificity than was originally anticipated
COMPLETE SECTIONS III, IV, V and VI
not in the consent form
investigator brochure
protocol
package insert
labeling
unanticipated in its frequency, severity, or specificity
related to the research procedures
harmful - caused harm to participants or others (e.g., investigators, research
assistants, students, the public, etc.), or placed them at increased risk of harm
COMPLETE SECTIONS III, V and VI
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Reportable Event Form
New Information
NYU School of Medicine IRB HRPP
new information indicating a change to the risks or potential benefits of the research,
in terms of severity or frequency.
IE: 1) 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 2) a paper is published from another
study that shows that the risks or potential benefits of your research
there are one or more attached reports from:
COMPLETE SECTIONS III, V and VI
e.g. Analysis indicates lower-than-expected response rate; other research finds arm of study has no
therapeutic value; FDA labeling change or withdrawal from market.
Confidentiality
Deviation or Violation
check all that apply
Complaint
Protocol Violation
Other Event
Sponsor-imposed
Incarceration
Unanticipated adverse device
effect
a breach of confidentiality
intended to eliminate apparent immediate hazard to a research participant,
harmful (caused harm to participants or others, or placed them at increased risk of
harm,
possible serious or continued noncompliance
COMPLETE SECTIONS III, V and VI
unresolved by the research team, or that indicates increased or unexpected risks;
Briefly Explain
COMPLETE SECTIONS III, V and VI
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
In the opinion of the PI it is in the best interest of the participant to remain on the
study
In the opinion of the PI the subject can be withdrawn from the study at this time and
will not be harmed due to this withdrawal
COMPLETE SECTIONS III, V and VI
New information about the effect on health or safety
Life-threatening problem or death caused by, or associated with, a device, (the
problem or death was not previously identified in nature, severity, or degree of
incidence, or any other unanticipated serious problem associated with a device that
relates to the rights, safety, or welfare of subjects.)
COMPLETE SECTIONS III, V and VI
III. Event Information
Date of the Event
Briefly describe the
circumstances of this Event
Describe this Event
Intensity
Was event study-related?
How long did the event last
Currently enrolled volunteers
will be notified of this event
Previously enrolled
volunteers will be notified of
this event
P.I.’s statement of this Event
in relation to the study
occurring at NYU
Anticipated Event - Already in Protocol
Other; describe:
Mild
Moderate
Severe
Unknown
Yes; describe method of notification:
No
Yes; describe method of notification:
No
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Reportable Event Form
NYU School of Medicine IRB HRPP
IV. Anticipated (Expected) Event
Complete this section only if you are reporting an Anticipated (Expected) Event that has changed and requires
updating; see Definitions section, above.
The risk of this event is
currently outlined in the
study’s consent form
The risk of this event is
currently outlined in the
study’s Investigator’s
Brochure (IB)
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 IB
Yes
No
Yes
No
V. Subject Information
For purposes of this form, the term “subjects” should be read to refer to all participants, patients, etc.
Subject age
if age is > 88, do not list age
just state “89 or above”
Subject gender
Subject Status
This event involved a subject
who was enrolled as a
healthy volunteer
Male
Female
00-Pre Screening
Yes
No: select from list
VI. Attachments
This event has prompted a
change to the Informed
Consent(s)/Assent(s):
This event has prompted a
change to the Protocol
Yes Attached version date is:
No
Yes Attached version date is:
No
This event has prompted a
Yes Attached version date is:
updated in the study’s
No
Investigator’s Brochure (IB)
If you answered “no” to any of
the questions above, explain
why you are reporting this
event to the IRB
Note: Any changes to your protocol, consent forms (etc.) must be submitted to the IRB on an Application for Amendment 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
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Reportable Event Form
NYU School of Medicine IRB HRPP
(For IRB Use Only)
Status
Noted
Full Board
Reviewer
Review Date
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