Reporting Events to the IRB

Investigators are to notify the IRB of any internal unanticipated problems or adverse events involving risks to participants or others that occur in
research conducted under the purview of the SJMHS IRB according to the schedule below. See IRB Policy: Unanticipated Events and Adverse Events
Reporting on the IRB website for more details: http://www.stjoesannarbor.org/irb-policies-procedures

What When How

Adverse event or unanticipated problem that is:
 Internal and
 Unexpected in nature, severity or frequency and
 Possibly, probably, or definitely related to the study,
and either:
 Serious (for FDA regulated study) or
 Suggests greater risk of harm than known or serious
(for OHRP regulated study)
Adverse event or unanticipated problem that is:
 External and results in a change to the informed
consent, protocol, or investigator brochure, and
 Unexpected in nature, severity or frequency and
 Possibly/probably/definitely related to the study,
and either:
 Serious (for FDA regulated study) or
suggests greater risk of harm than known or
serious (for OHRP regulated study).
Participant death that is:
 Internal and
 unanticipated and
 possibly, probably or definitely related to the study
Participant death that is:
 Internal and
 anticipated or
 due to disease progression or
 not related or unlikely related or
not a greater risk of harm than was previously known
(if OHRP-regulated)
SJMHS Research Compliance Department 8/2016
1) Must be reported within 3 business
days of the knowledge of the event or
as dictated by the protocol.
2) Must be included, again, as a
summary, at continuing review or
closure, whichever occurs next.
1) Report these external events to the IRB
within 5 business days of knowledge.
2) Must be reported to the IRB within 24
hours of the knowledge of the death
either by email, phone or fax.
3) A signed Adverse Event form must be
received by the IRB within 5 business
days of knowledge of the event.
3) Must be included, again, in summary,
at continuing review or closure,
whichever occurs next.
Report to the IRB at continuing review or
closure, whichever occurs first.
SJMHS IRB Internal Adverse Event and
Unanticipated Problem form
SJMHS IRB Continuing Review or Closure
form
SJMHS IRB
Request for Revision form plus the Action
Letter or other communication that required
the changes.
SJMHS IRB Internal Adverse Event and
Unanticipated Problem form
Log the incident in the SJMHS VOICE
system or other SJMHS system
SJMHS IRB Continuing Review or Closure
form
SJMHS IRB Continuing Review or Closure
form
Do not report via an Internal Adverse Event
and Unanticipated Problem form
 Event that is: Report to the IRB at continuing review or SJMHS IRB Continuing Review or Closure
 Anticipated or closure, whichever occurs first. form
 External or
 Unlikely to be related or not serious or Do not report via an Internal Adverse Event
not a greater risk of harm than was previously and Unanticipated Problem form
known (if OHRP-regulated)

Device Studies Only

What
For device studies, PI report of a
Unanticipated Adverse Device Effect
(UADE) that is:
 unanticipated
 serious problem or affect
 associated with a device
to the:
• sponsor and
• SJMHS IRB
For device studies where the hospital
(which is not a physician’s office) is a
Device User Facility, the PI or hospital
must report:
participant deaths that are
SJMHS Research Compliance Department 8/2016
When How
1) Deaths- notify IRB within 24 hours of knowledge of death and submit SJMHS IRB Internal
Internal Adverse Event and Unanticipated Problem form to IRB within 5 Adverse Event and
business days. Updates may need to be submitted, such as cause of Unanticipated Problem
death, attribution, etc. form
2) UADEs that were not fatal: report as soon as possible, but in no event
later than 10 business days after the investigator first learns of the event May need to report to
[21 CFR 812.150(a) (1)] SJMHS VOICE system or
3) Per the FDA, Sponsors must immediately conduct an evaluation of a other SJMHS system
UADE and must report the results of the evaluation to FDA, all reviewing
IRBs, and participating investigators within 10 business days after the
sponsor first receives notice of the effect [21 CFR 812.46(b), 21 CFR Letter from the sponsor to
812.150(b)(1)]. the PI and forward it to the
4) Sponsors that determine that an unanticipated adverse device effect IRB.
presents an unreasonable risk to participants will terminate all
investigations or parts of investigations presenting that risk as soon as
possible. Termination must occur no later than 5 working days after the
sponsor makes the determination and no later than 15 working days after
the sponsor first received notice of the effect [21 CFR 812.46(b(2)].
Terminated studies require FDA and IRB approval to resume [see 21 CFR
812 for more details].
5) Must be included, again, in summary at continuing review or closure, SJMHS IRB Continuing
whichever occurs next. Review or Closure form
Per 21 CFR 803.30:
1) Report participant death within 10 business days of becoming aware of Form FDA 3500A
information, from any source, that reasonably suggests* that a device has
or may have caused or contributed to a participant death at this facility to: See FDA Guidance
• FDA document: Medical Device
• manufacture of the device Reporting for User
  suspected to be medical device-
related*
participant serious injuries that are
 suspected to be medical device-
related*
* You are not required to evaluate or
investigate the event by obtaining or
evaluating information that you do not
reasonably know.
2) Report participant serious injury within 10 business days of becoming Facilities at:
aware to the: http://www.fda.gov/downlo
• Manufacturer (or to FDA if manufacturer is unknown). ads/MedicalDevices/Devic
eRegulationandGuidance/
GuidanceDocuments/UCM
095266.pdf
3) Annual summary of death & serious injury reports sent to the FDA by Form FDA 3419
January 1 for the preceding year.

SJMHS Research Compliance Department 8/2016