FAQs: SAE form and reporting events
- What is the purpose of the IRB worksheet? Do I have to submit it every time I use it?
The SAE Worksheet helps you decide if an adverse event requires reporting to the NYSPI IRB. The nature of the information, your assessment of its importance, and the IRB's responsibilities for the site drive the algorithm.
We think the form will reduce workload by eliminating the unnecessary flow of reports when such reporting does not enhance human subjects protections. If the worksheet indicates "do not submit" or "do not proceed" you are not required to submit anything (not even the worksheet).
- I don't understand when the NYSPI IRB has responsibility and when it doesn't.
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 and unexpected adverse events must be reported.
There are other circumstances where a PI/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 serious and/or unanticipated AEs must be reported from the site. If a local IRB has reviewed and commented on the event, we ask that you share this information with us.
- Do I need to submit something to the IRB whenever the sponsor sends me an AE report?
No, the whole point of the revised policy is that the distribution of unanalyzed adverse event reports from event site to sponsor to investigator to IRB doesn't protect research subjects.
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. All of those studies are unrelated to yours and your study population.
According to the worksheet, you must make a determination as to whether the event is relevant to your study intervention, if it impacts on your study's risk/benefit analysis, or it requires changes to your consent form language (worksheet question 3). If yes, provide a summary of this info with your assessment and a modified protocol or consent for review. Do not complete our SAE form and please do not send unanalyzed IND safety reports.
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. The worksheet will lead you to item 4, and the answer here is Yes. Complete an SAE form.
- What happens in the IRB once I submit my AE report?
All reports are reviewed by the IRB monitor, the IRB Chair or Vice Chair, 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:
no further action on your part is indicated,
additional information or analysis is required before a determination can be made,
- review of the event by convened meeting of the IRB is required.
You will notified of all determinations and actions.
- Are there other reporting requirements?
IRB leadership routinely discuss serious adverse events with NSYPI administration and leadership in OMH and RFMH Central Office.
Certain unanticipated problems require the institution to provide a report to the Office of Human Subjects Research (OHRP), the funding agency (e.g. NIH), or the study sponsor. We will discuss this with you when necessary.
Principal investigators are responsible for familiarizing themselves with other requirements. For example:
Local incident and adverse event reporting requirements at the research site.
NYSPI has a separate incident reporting policy when Office of Mental Health Patients are participants. Contact the Office of Quality Management for information.
Requirements of the funding agency or study sponsor regarding adverse event reporting.
FDA reporting requirements for studies conducted under an IND or IDE.
- Radiation safety committee requirements regarding adverse events related to radioactive compounds.
- How much information is needed on the SAE Form Question 9?
We really need you to 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 report of all events similar to the one you are reporting. However, we do think a brief summary statement in the comments section can address the question. If warranted, the IRB will request further information.