Institutional Review Board
Adverse Event Reporting Form
Adverse Event Reporting Guidelines:
Since the IRB is responsible for the continued assessment of the risks versus benefits of research
involving human subjects, investigators are required to notify the IRB of adverse events (AEs) that
have been designated serious and unexpected.
An Adverse Event is defined as any unfavorable and unintended sign (including abnormal laboratory
finding), symptom, or disease temporally associated with the use of a medical treatment or procedure,
regardless of whether it is considered related to the medical treatment or procedure.
Serious Adverse Events (SAEs) are any adverse experiences occurring that result in any of the
following outcomes: death, a life-threatening adverse experience, inpatient hospitalization or
prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital
anomaly/birth defect. Death is never expected.
An Unexpected Adverse Event (UAE) means any adverse experience that is not identified in nature,
severity or frequency in the current investigator brochure, study protocol, or consent form. (CFR
312.32 (a)).
Two types of SAEs are identified:
Internal Adverse Event if the event is serious and unexpected and has occurred to a subject enrolled
at AUB/AUBMC, and/or other research site under the jurisdiction of AUB and is associated with the
research intervention. The PI is required to report the event directly to the IRB and to the Sponsor
within 10 days of the PI’s knowledge of the event.
External Adverse Event if the event is serious and unexpected and has occurred at an external site
and is reported to the IRB or to the PI by external sponsors of multicenter studies and is associated
with the research intervention. The PI typically receives notification of these events from the sponsor.
The definition of an SAE may vary depending on whether the research involves a drug, investigational
device or research-related invasive procedure.
An investigator shall promptly report to the sponsor any adverse effect that may reasonably be
regarded as caused by, or probably caused, by the drug. If the adverse effect is alarming, the
investigator shall report the adverse effect immediately (CFR 312.65 (b), for drug related SAE).
An investigator shall submit to the sponsor and to the IRB a report of any unanticipated adverse device
effect occurring during an investigation as soon as possible, but not later than 10 working days after
the investigator first learns of the effect (CFR 812.150 (a), for device related SAE).
The IRB will review all serious adverse event reports to reevaluate the risks ad benefits of the
research, need for changes, etc. Principal investigators will be notified of any action taken.
Institutional Review Board
Version #1, December 2005
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Please Complete the following information:
Date of the report:
Principal Investigator:
Department:
Protocol Number:
Protocol Title:
Patient Number:
(if applicable)
Patient Initial:
Subject’s Age:
Gender:
Date of the Event:
Is the Event continuing: — Yes
*If No: Date of Event Termination:
Is this a new Report? — Yes
* If No, Date of the First Report:
Phone #:
Case Number at
AUBMC:
(if applicable)
— No*
— No* (it is a follow up report)
Description of the Adverse Event:
Briefly describe the adverse event. Include patient’s demographics and pertinent medical information
(e.g., diagnosis, physical exam, lab values, concomitant medications, etc.), treatment the subject
received before and after the event (if applicable), subject’s prognosis, and final outcome, including
whether the subject remains on study.
NB: If the event occurred to a subject at another site, the PI can attach the form provided by the
sponsor in place of the description.
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Version #1, December 2005
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Treatment provided to the subject:


Date of Treatment:
Describe the treatment provided to the subject:

Describe the outcome of treatment:
The Event/problem was:
—
—
—
—
—
—
Mild (transient or mild discomfort (< 48 hours); no medical intervention/therapy required)
Moderate (mild to moderate limitation in activity; minimal medical intervention required)
Severe (Marked limitation in activity; medical intervention/therapy required)
Resulted in hospitalization or prolonged hospitalization
Resulted in permanent disability
Resulted in Death (Date of Death:
)
Relationship to Research intervention:
— Highly probable (the AE has a timely relationship to the study procedures and follows a known
pattern of response for which no alternative cause is present)
— Probably related (the AE has a timely relationship to the study procedures and follows a known
pattern of response for which a potential alternative cause may be present)
— Possibly related (a causal relationship can not be eliminated)
— Unlikely (there is a low probability that the research intervention caused the AE) or (another
causative alternative exists to account for the AE)
— Assessment not provided.
Describe the suspected cause of the Adverse Event:
— Underlying disease:
— Concomitant medication/drug:
— Disease progression:
— Procedure:
— Other. Specify:
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Version #1, December 2005
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Protocol Data:






Is this a:
— Therapeutic protocol
— Non-Therapeutic protocol
Is this AE (Adverse Event) listed in the investigator brochure? — Yes
Is this AE listed in the protocol?
— Yes
Is this AE listed in the informed consent form?
— Yes
Has this AE previously occurred on this protocol?
— Yes*
*If yes, how many times?
Has the sponsor provided any data on the frequency of this AE? — Yes*
*If yes, please attach to this report.
— No
— No
— No
— No
— No
Changes necessitated by AE:


Are any changes required in the informed consent/assent document(s) to better inform and protect
the rights and welfare of subjects?
— Yes*
— No (why? :
).
*If yes, please attach a revised consent/assent form with changes highlighted.
Is it necessary to inform subjects/legally authorized representatives who have already consented to
participation in the study of the event or problem?
— Yes. It will be done and documented (if a change has been made in the consent form, the new
form must be signed)
— No (why? :
).
Signature:
Principal Investigator’s Signature
Date
IRB Comments
— The IRB took note of the AE and did not request any action
— The IRB requests modifications as follows:
Chairman’s Name and Signature
Institutional Review Board
Version #1, December 2005
Date
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