Transcript Reportable Events - Emory Institutional Review Board

Reportable Events
Emory IRB
9/11/2014
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What will be covered in this webinar?
 Reportable Events and the VA
 Definitions
 Protocol Deviations
 Unanticipated Problems
 SUSARs and SAEs
 Non-compliance
 Sponsor requirements
 Cases
 How to report to the IRB
 IRB resources
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Reportable events and the VA
Before reporting any event to us, make sure you have followed
the Atlanta VA reporting requirements. This may include
reporting to them first using a VA specific form. Reference this
link for more information:
http://www.atlanta.va.gov/services/research/investigators.asp
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Definitions
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Definitions
 Serious Adverse Event (SAE): An event resulting in death, a
life-threatening experience, inpatient hospitalization or
prolongation of existing hospitalization, a persistent or
significant disability/incapacity, or a congenital
anomaly/birth defect
 Internal event: event that occurred in participants enrolled
at Emory or in a site under Emory IRB’s oversight
 External event: events that occurred in participants who
were not enrolled at Emory or at sites under Emory IRB’s
oversight
 Promptly reportable: reportable within 10 business days
from when the study team learned about it
 Periodically reportable: reportable at continuing review
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Noncompliance
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Noncompliance
 Failure to follow the
regulations, Emory P&Ps, or
Emory IRB determinations
 Please consult with IRB QA
and Education Team
 Root cause analysis
 CAPA plans
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Protocol Deviations
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Protocol Deviations
 What to report? Not all protocol
deviations
 Substantive and negatively affecting:
 Rights, safety or welfare
 Willingness to continue with study
participation
 Integrity of research data
 When to report: Promptly
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Unanticipated Problems
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Unanticipated Problem
 What to report? Event that is:
 Related to study participation
 Unanticipated (not described or
unknown before)
 Poses an increased risk for
participants or others
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Unanticipated Problems
 Examples of UPs:
 New SAE in a subject (or subjects) that was unknown
and that will be added to the ICF.
 SAE previously described in the ICF but that is
occurring in a higher frequency, severity or duration
 An event that it is not an SAE but that increases risk.
E.g., a stolen laptop containing subjects’ PHI
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UPs: SUSARs and SAEs
 SUSARs: sponsor’s reports of Suspected Unexpected
Serious Adverse Reactions. Probably reportable to the IRB
unless PI assessment indicates otherwise
 SAEs: Not promptly reportable unless they are also UPs OR
if they are a related, internal death
 When to report SAEs that are not UPs:
 At continuing review: If event is anticipated, internal, and
related (expected SAE)
 Never: If event is unrelated, but not a death. If event is a
related internal death, even if anticipated: report promptly
 External events: not reportable, unless they represent UPs
(even if it is a death)
 Except: If external site is participating in an Emory sponsorinvestigator study, it should be treated as if it was internal
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Sponsor Reporting Requirements
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Sponsor Reporting Requirements
 In general, sponsors want to receive reports of protocol
deviations and SAEs, even if not reportable to IRB
 Keep logs to report and trend data
 Sometimes sponsors wants you to report an event to the
IRB, even if it is not reportable
 What to do? Check your protocol and contract. If required,
you have to report
 What would the IRB do? We will review it and acknowledge
it for your records
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Cases
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Case #1
A medical student, who is not on the IRB-approved list of
study personnel, consents a subject for enrollment into a
clinical trial
 Noncompliance
 Report or consult with the IRB
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Case # 2
A subject comes late to a study visit at the infusion
center, and as a result, gets the study medication 2
hours late
 Protocol Deviation
 Go through reporting requirements to see if it
needs to be reported to the IRB
 Report to sponsor per their requirements
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Case # 3
You receive a Medwatch form that reports a death
from a car accident in a subject participating in your
trial in Texas. The PI in Texas calls it not related to the
study
 Go Through UP Questions
 See if you and the Emory PI agree it is not
related
 If not a UP, then it does not need to be reported
to the IRB
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Case # 4
You read a notice on the FDA website about a new, unexpected
side effect seen in your study drug
 Review UP Questions in guideline
 Report to the IRB if it is an UP
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Case # 5
The sponsor sends you a letter reporting a SAE. The SAE is
being reported as a UP, but the Emory PI disagrees with the
sponsor. What is the process to follow?
 Report the event as a UP to the IRB
 State that the Emory PI does not agree with this
assessment
 The FDA puts the responsibility of assessment on the
sponsor (IND or IDE holder)
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Case # 6
A subject receiving the study drug was hospitalized after
having a stroke. The subject has a history of diabetes,
and had a TIA in the past year. The PI does not think
this event is related to study participation but is very
concerned about the subject. Is this serious event
reportable to the IRB?
 The event is not related. As such, is not
reportable to the IRB
 Follow your protocol/contract for your sponsor
reporting requirements
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Case # 7
A subject had SAE. The SAE is described in the study docs
as a possible adverse event, but the subject is experiencing a
move severe SAE than anticipated. The PI thinks this is
possibly related
 If the event is not greater in severity, duration or
frequency= not a UP, not reportable
 Keep AE/SAE logs to evaluate for patterns indicating an
increase in severity, frequency or duration beyond what is
described in the protocol
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How to report to IRB
 Protocol deviations: eIRB RE form.
Indicate if event was reported because a
third party required it (e.g., Sponsor)
 UPs: also eIRB RE form. Indicate if event
happened at Emory or at an external site
 Events a CR: summary of events. Do not
use eIRB form for it
 Noncompliance: eIRB RE form. Report it
using the protocol deviation option
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How to report to IRB
For PD and NC
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How to report to IRB
To report complaints by
subjects
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How to report to IRB
Internal events
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How to report to IRB
External events
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How to report to IRB
Do not use.
Summarize
events and
submit with CR
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How to report to IRB
When
submitting
reports that
indicate an
increase in risk
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IRB resources
 Find resources in our website at
http://www.irb.emory.edu/forms/reportable.html
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IRB Resources
Also call the QA and Education team
 Maria G. Davila
(404)712-0724 or [email protected]
 Shara Karlebach
(404)712-0727 or [email protected]
 Kevin Wack
(404)712-5220 or [email protected]
 Sean Kiskel
(404)712-0766 or [email protected]
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Questions?
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