ADVERSE EVENT REPORTING GUIDE
Jacksonville – IRB-03
This questionnaire should be used to help the Principal Investigator to determine how,
when, and where to report adverse events. This form is a guide to assist investigators
and should not be submitted to IRB-03.
DEFINITIONS FOR ADVERSE EVENT REPORTING:
A serious adverse event is any adverse event that results in any of the following outcomes:
 death,
 a life-threatening adverse event,
 inpatient hospitalization or prolonging existing hospitalization,
 a persistent or significant disability/incapacity or a congenital anomaly/birth defect.
Important medical events that may not result in death, be life-threatening, or require
hospitalization may be considered a serious adverse event when, based upon appropriate
medical judgment, the event may jeopardize the patient or subject and/or may require
medical or surgical intervention to prevent one of the outcomes listed in the definition above.
An unexpected adverse event is any adverse event that is:
not consistent with the current investigator brochure, protocol, and/or consent form
not part of the normal disease progression
known adverse events occurring more frequently than expected
IRB-03 considers all deaths to be Serious and Unexpected, even if it is a possible outcome
of disease progression. All deaths on any Expedited or Full Board study must be reported
within five working days, even if the PI considers the death to be unrelated to the study.
A local adverse event is an adverse event that occurs in a subject enrolled in a protocol
that is under the supervision of a University of Florida Institutional Review Board-approved
Principal Investigator. It does not matter where the subject experiences the adverse
experience or where the subject may be treated for that adverse experience, the adverse event
is still considered “local.”
CAUSAL RELATIONSHIP OF ADVERSE EVENTS TO STUDY INTERVENTIONS:
A “related” causal relationship between a study intervention and an adverse event exists when
the reaction follows within a reasonable time after the administration of the study drug or
intervention, follows a known response pattern to the suspected study intervention, and is
confirmed by improvement when the study intervention has stopped and the reaction reappears
when the intervention is re-administered, or the patient has documented toxic concentrations of
the study drug or evidence of the intervention in the blood or other fluid. A “related” causal
relationship exists for drug overdoses in a patient with consistent symptoms, exhibits
documented toxic concentrations in blood or other fluids, or responds to a specific antidote.
Adverse Event Reporting Guide
IRB version date: 11/24/09
Page 1 of 3
A “cannot be ruled out” causal relationship exists when the reaction follows a known response
pattern to the study intervention and is confirmed by improvement when the intervention is
stopped, cannot be reasonably explained by the known characteristics of the condition being
treated or, when the reaction follows within a reasonable time after the administration of the
study drug or intervention, follows a known response pattern to the suspected intervention but
could have been caused by the condition being treated or by other interventions.
1. Did this event occur to a subject enrolled (who signed an Informed Consent and/or
underwent any study interventions, including tests to determine eligibility), either at UF or at
another site, on the protocol that has been approved by IRB-03?

Yes, this event occurred to a subject who participated in the same exact study that
has been approved by IRB-03. Go to question #2.

No, this event occurred to a subject enrolled on a different protocol at a different
site. IRB-03 does not require you to submit these events. If the study sponsor
requires you to submit this event to IRB-03 (e.g. perhaps the IND # is the same),
please use our “Adverse Event Report – Non-reportable Event” form available on the
IRB-03 website. Do not list this event in your project’s Cumulative AER Table. Do
not proceed further on this form.
2. Is the adverse event Serious and Unexpected according to IRB definitions? IRB-03
considers all deaths to be Serious and Unexpected. Please see the first page of this Guide to
see what IRB-03 considers serious and unexpected.
 Yes; Report this event to IRB-03 within 5 working days of when you learned about it
using the “Serious and Unexpected Adverse Event & Safety Report Form” available
on the IRB-03 website. Do not proceed further on this form.
 No; This event is not both Serious and Unexpected. Go to question #3.
3. Is the adverse event either Serious or Unexpected according to the IRB definitions?

No, go to question #4.

Yes; answer question #3.a.
a.Did this event occur to a subject enrolled locally?

Yes, the event occurred to a subject enrolled locally. Please report this event to
IRB-03 at Continuing Review on the Cumulative Adverse Event Summary Table.
Do not proceed further on this form.

No, the event occurred to a subject enrolled at another site. Answer b.
b.Does this study have a DSMB or Sponsor oversight committee?

No, there is no DSMB/Sponsor oversight. Report this event to IRB-03 on the
Cumulative Adverse Event Summary Table. Do not proceed further on this form.

Yes, there is a DSMB/Sponsor oversight. IRB-03 does not require you to report
this event. Do not list this event in your project’s Cumulative Adverse Event
Adverse Event Reporting Guide
IRB version date: 11/24/09
Page 2 of 3
Summary Table. However, if your sponsor requires you to report this event to
IRB-03, please use our Adverse Event Report – Non-Reportable Event form.
Do not proceed further on this form.
4. Is the adverse event both Expected and Not Serious?

No, you do not consider the event to be both Expected and Not Serious. Please reevaluate your classification of the adverse event. All adverse events will fall into one
of three categories listed above: (1) Unexpected and Serious, (2) either Unexpected
or Serious, or (3) Expected and Not Serious.

Yes, this event is both Expected and Not Serious. Answer a.
a. Did the event occur to a subject enrolled locally?

Yes, the event occurred to a subject enrolled locally. Please report this event to
IRB-03 at Continuing Review on the Cumulative Adverse Event Summary Table.
Do not proceed further on this form.

No, the event occurred to a subject enrolled at another site. IRB-03 does not
require you to report this event. Do not list this event in your project’s Cumulative
Adverse Event Summary Table. However, if your study sponsor requires you to
report this event to IRB-03, please use our Adverse Event Report – NonReportable Event form.
Adverse Event Reporting Guide
IRB version date: 11/24/09
Page 3 of 3