1. Reportable Events
Emory IRB
9/11/2014

2. 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

3. 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:

4. Definitions

5. 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

6. Noncompliance

7. 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

8. Protocol Deviations

9. 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

10. Unanticipated Problems

11. 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

12. 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

13. 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 sponsor- investigator study, it should be treated as if it was internal

15. Sponsor Reporting Requirements

16. 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

17. Cases

18. 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

19. 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

20. 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

21. 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

22. 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)

23. 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

24. 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

25. 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

26. How to report to IRB
For PD and NC

27. How to report to IRB
To report complaints by subjects

28. How to report to IRB
Internal events

29. How to report to IRB
External events

30. How to report to IRB
Do not use. Summarize events and submit with CR

31. How to report to IRB
When submitting reports that indicate an increase in risk

32. IRB resources
Find resources in our website at

33. IRB Resources Also call the QA and Education team Maria G. Davila
(404) or
Shara Karlebach
(404) or
Kevin Wack
(404) or
Sean Kiskel
(404) or

35. Questions?