Serious Adverse Event
What is a serious and/or unexpected adverse event? A serious adverse event is any event that results in death, life threatening experiences, hospitalizations or prolongation of hospitalization, disability or incapacitation, overdose, congenital anomalies or other serious events that may jeopardize the participant or require medical or surgical intervention to prevent any of the outcomes listed in this definition.
- How do I file an SAE/UP report?
All SAE and unanticipated problems (UP) reports are filed in PRISM under the tab titled "Start a Protocol Violation/Serious Adverse Event Form". SAE/UPs can only be submitted in PRISM under te login credentials of the study's Principal Investigator. No other member of the research team can submit an SAE/UP report through PRISM.
For SAE/UPs, the process begins with the SAE/UP worksheet. The SAE/UP worksheet questions are designed to help you decide if an adverse event requires reporting to the NYSPI IRB based upon the nature of the event, your assessment of its importance and the NYSPI IRB's responsibility for oversight of the research.
If the worksheet indicates "do not submit" or "do not proceed", you are not required to submit anything (not even the worksheet).
- When does the NYSPI IRB have responsibility and when does it not?
If the CU or RFMH grants office funds research at the study site, we assume responsibility for the conduct of the study; therefore, all serious adverse events and unanticipated problems must be reported.
There are other circumstances where a NYSPI/CU investigator is assuming overall responsibility for a multi-site study, regardless of funding. Our responsibility is evidenced by the fact that the site is listed on the face page of the PSF, we approve enrollment at the off-site location, we require evidence of local IRB approval, and we approve their consent forms. If so, then all SAEs and unanticipated problems must be reported from the site. If a local IRB has reviewed and commented on the event, we ask that you include this information with your report. Supporting documents can be uploaded in PRISM with your SAE/UP report.
- Do I need to submit something to the IRB when the sponsor sends me adverse event reports?
No, the distribution of unanalyzed adverse event reports from event site to sponsor to investigator to the NYSPI IRB doesn't assist the IRB with its responsibility to protect research participants. The NYSPI IRB requires reporting of adverse events from sites not under its jurisdiction only when the NYSPI Principal Investigator has reviewed the report and determined: a)the event is related to the study intervention, b) the event could impact the risk/benefit analysis of the study taking place at NYSPI, and c) the event would require changes to the consent form language.
Example: You get many IND safety reports from the sponsor of your clinical trial since the drug is in widespread use in post-marketing studies. Those studies are usually unrelated to yours and your study population.
According to the worksheet, you must make a determination as to whether the event is related to your study intervention, if it impacts on your study's risk/benefit analysis, and if it requires changes to your consent form language. If the answer to all three is "yes", submit an SAE/UP report in PRISM. If the answer to any of the three is "no", do not submit a report.
Example: You are the local PI of a clinical trial employing a medication marketed for a different indication. A series of adverse event reports are forwarded to you by the sponsor describing new evidence, from other performance sites of the same study, that the medication appears to be associated with a lowering of white blood cell counts. This appears to be an unanticipated problem related to the study intervention that changes the risk/benefit analysis for your study and requires changes to the consent form. Complete an SAE/UP report in PRISM.
How much information do you want in response to the following question on the SAE/UP report: Have any unexpected events, similar to the one you are reporting, previously occurred in this study or in any related studies?
Please use your judgment here. Review the adverse event history of the study or intervention and carefully consider if the current adverse event has more, or less, significance in the context of previous occurrences. While a single event may mean little, a series of events might be of importance.
It is certainly not helpful to submit an extensive outline of all events similar to the one you are reporting unless you are of the opinion that, in aggregate, the events potentially represent an unanticipated problem. However, we do think a brief summary statement in the comments section can address this question. If warranted, the IRB will request further information.
- What happens in the IRB once I submit my SAE report?
All reports are reviewed by the IRB monitor, the IRB Chair or designee, or the Full Board, depending on the nature of the event and the perceived impact on study risks or benefits. The Full Board receives a periodic summary of all adverse event reports. This information is considered a central part of the continuing review process.
During initial review by the monitor or chairs, we will determine that:
You will be notified of all determinations and actions.
- no further action on your part is indicated,
- additional information or analysis is required before a determination can be made, or
- review of the event by convened meeting of the IRB is required.