Title
Reporting Adverse Events and
Unanticipated
Problems to the IRB
November
18, 2016
Flow Chart 1
What type of study did the event occur
during?
Food and Drug Administration (FDA) regulated
studies involve a test article (i.e., investigational drug,
device, biologic, vaccine) and one or more human
participants, and either meets requirements for prior
submission to FDA under 505(i) or 520(g), or does not
meet these requirements, but results are intended to be
submitted to, or held for inspection by, the FDA as part of
an application for a research or marketing permit.
Office of Human Research Protection (OHRP) regulated studies
are a systematic investigation, including research development, testing
and evaluation, designed to develop or contribute to generalizable
knowledge. Activities which meet this definition and involve "a living
individual about whom an investigator conducting research obtains
data through intervention or interaction with the individual, or
identifiable private information".
A study regulated by
both the FDA and OHRP
Go to CHART 2
if a drug,
biologic or
vaccine is
being used;
Go to CHART 3
if a device is
being used
Go to CHART 4
Page 1
FDA Regulated Study: Drug, Biologic or Vaccine Adverse Event or Experiences Reporting
Flowchart 2
INTERNAL EVENT
EXTERNAL EVENT
Report to the IRB during Continuing Review using the
AE & UP Summary Log or when closing study on the
Study Close-Out form.
Anticipated
(i.e. disease
progression)
Did a death occur?
Yes
No
Unanticipated
No
Did the event occur during
the conduct of the study?
(i.e. still reporting data)
Is this possibly,
probably, or
definitely related to
the study?
Notify the IRB within 24 hours of knowledge. Submit
Internal Adverse Event and Unanticipated Problem form to
IRB within 5 business days. Updates may need to be
submitted, such as cause of death, attribution, etc.
Yes
Do Not Report to the IRB unless specified by
sponsor or protocol (does not meet SJMHS AE
reporting requirements).
No
Was the event reported to the PI in an
Action Letter or other communication that
requires a change to the informed consent,
protocol, or investigator brochure, due to a
new risk or a change in the risk/benefit
ratio?
YES
NO
Yes
Did a serious adverse
event occur? *
Yes
Is event unanticipated
and/or
unexpected in terms of
nature, severity, or
frequency?
No
Yes
No
Is the adverse event
related (possibly,
probably, definitely)
to study drug,
device, or
intervention?
No
Yes
Do Not Report to the IRB unless specified by
sponsor/protocol (does not meet SJMHS AE &
UP reporting requirements).
Report to the IRB within 5
days of knowledge by
submitting the action letter and
any supporting documentation
available, i.e. updated
protocol, consent, IB.
Submission to the IRB not
required. If sponsor requires,
submit in summary format
during Continuing Review.
Report to the IRB during
continuing review or study
closure using the AE & UP
Summary Log
Report to the IRB
within 3 working days
of knowledge. Use
Internal Adverse Event
Form.
For additional information, see SJMHS IRB policy: Unanticipated Problem and Adverse Event Reporting
*Serious in that the event was life-threatening, unplanned hospitalization required initially or prolonged, persistent or significant disability, resulted in a congenial birth defect, requires treatment or intervention to
preclude permanent impairment or damage, or an other important medical event.
6/2016
FDA Regulated DEVICE Study: Unanticipated Adverse Device Effect Reporting
Flowchart 3
INTERNAL EVENT
EXTERNAL EVENT
Report to the IRB during Continuing Review using the
AE & UP Summary Log or when closing study on the Study CloseOut form.
Anticipated
(i.e. disease
progression)
Did a death occur?
Unanticipated
No
No
Was the event reported to the PI in an
Action Letter or other communication that
requires a change to the informed consent,
protocol, or investigator brochure, due to a
new risk or a change in the risk/benefit
ratio?
Yes
Is this associated
with the device?
Yes
Notify the IRB within 24 hours of knowledge. Submit Internal
Adverse Event and Unanticipated Problem form to IRB within 5
business days. Updates may need to be submitted, such as
cause of death, attribution, etc.
If the hospital is a Device User Facility, see IRB UP and AE
Reporting policy for further reporting requirements.
Yes
Did the event occur during the conduct of the study?
(i.e. still reporting or collecting data)
No
Do Not Report to the IRB unless specified by sponsor or protocol
(does not meet SJMHS UADE reporting requirements).
Yes
Did a serious problem or effect
occur?*
Yes
Is event unanticipated and/or
unexpected in terms of nature, severity, or
frequency?
Yes
Report to the IRB within 5
days of knowledge by
submitting the action letter
and any supporting
documentation available, i.e.
updated protocol, consent, IB.
No
Is the effect
associated with
the device?
No
Report to the IRB during
continuing review or study closure
using the AE & UP Summary Log
No
Yes
Do Not Report to the IRB (does not meet
SJMHS UADE reporting requirements),
unless specified by sponsor or protocol.
NO
Individual external events are
not required to be submitted
to the IRB. If sponsor
requires, submit in summary
format during Continuing
Review.
Report to the IRB AND to the sponsor as soon as
possible, within 10 business days of knowledge. Use
Internal Adverse Event and Unexpected Problem Form.
If the hospital is a Device User Facility, see IRB UP and
AE Reporting policy for further reporting requirements.
For additional information, see SJMHS IRB policy: Unanticipated Problem and Adverse Event Reporting
If the hospital is a Device User Facility, see IRB UP and AE Reporting policy for further reporting requirements.
Medical device - any item that is used for the diagnosis, treatment, or prevention of a disease, injury, or other condition and is not a drug or biologic.
*Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature,
severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to
the rights, safety, or welfare of participants [21 CFR 812.3(s)].
6/28/2016
OHRP Regulated Study: Unanticipated Problem Reporting
Flowchart 4
INTERNAL EVENT
Anticipated
Did a death
occur?
No
Yes
No
EXTERNAL EVENT
Report to the IRB during Continuing Review
using the AE & UP Summary Log or when closing
study on the Study Close-Out form.
Unanticipated*
Is this related or
possibly related to the
study?
Yes
Was the event reported to the PI in an
Action Letter or other communication
that requires a change to the informed
consent, protocol, or investigator
brochure, due to a new risk or a
change in the risk/benefit ratio?
Notify the IRB within 24 hours of knowledge.
Submit Internal Adverse Event and
Unanticipated Problem form to IRB within 5
business days. Updates may need to be
submitted, such as cause of death,
attribution, etc.
Yes
Did the event occur during the
conduct of the study?
No
Do Not Report to the IRB unless specified by sponsor or protocol
(does not meet SJMHS AE & UP reporting requirements).
Yes
Does the research place
participants or others at a
greater risk of harm
(including physical,
psychological, economic,
or social harm) than
previously known or
recognized OR is this
considered serious*?
Is event unanticipated and/or
unexpected in terms of nature,
severity, or frequency?**
No
Yes
Yes
Is event possibly related or
related to the research?
Individual external events
are not required to be
submitted to the IRB. If
sponsor requires, submit
in summary format during
Continuing Review.
No
Yes
No
Report to the IRB
during continuing
review or study closure
using the AE & UP
Summary Log
Report to the IRB within 5
days of knowledge by
submitting the action letter
and any supporting
documentation available,
i.e. updated protocol,
consent, IB.
No
Do Not Report to the IRB
(does not meet SJMHS AE & UP reporting
requirements), unless specified by sponsor or
protocol.
Report to the IRB
within 3 working days
of knowledge. Use
Internal AE & UP
Form.
For additional information, see SJMHS IRB policy: Unanticipated Problem and Adverse Event Reporting
*Serious in that the event was life-threatening, unplanned hospitalization required initially or prolonged, persistent or significant disability, resulted in a congenial birth defect, requires treatment or intervention
to preclude permanent impairment or damage, or an other important medical event?
**Unexpected (in terms of nature, severity, or frequency) given: (1) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed
consent document; and (2) the characteristics of the participant population being studied.
6/28/2016