Reportable Events Emory IRB 9/11/2014

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

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

Definitions

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

Noncompliance

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

Protocol Deviations

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

Unanticipated Problems

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

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

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

Sponsor Reporting Requirements

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

Cases

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

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

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

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

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)

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

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

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

How to report to IRB For PD and NC

How to report to IRB To report complaints by subjects

How to report to IRB Internal events

How to report to IRB External events

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

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

IRB resources Find resources in our website at http://www.irb.emory.edu/forms/reportable.html

IRB Resources Also call the QA and Education team Maria G. Davila (404)712-0724 or maria.davila@emory.edu Shara Karlebach (404)712-0727 or shara.karlebach@emory.edu Kevin Wack (404)712-5220 or kwack@emory.edu Sean Kiskel (404)712-0766 or skiskel@emory.edu

Questions?