Regulatory Update #1 –What SAEs are unanticipated problems and need to be reported to the IRB?
You may have used the new Reporting Form in notifying Liberty IRB of adverse events and/or protocol deviations. If you have not, this is the only form that should now be used. There is no separate form for protocol deviations as there used to be. It is located on our website www.libertyirb.com under Investigator and then Forms.
If you have used this form you may have been confused. We were at first! The form is the result of an attempt by the FDA and OHRP to require similar reporting and because in the years since the IRB and IND regulations were issued, changes in the conduct of trials (e.g., multi-center studies, international trials) have complicated reporting for adverse event information. The Reporting Form was approved for use by AAHRPP and discussed with our FDA representative during a recent audit. We will send several e-mails over the next few weeks in an attempt to explain it and how it should be filled out. Please read each of these and ask any questions. Understanding what is required will make both reporting on your end and review on ours easier.
You will note there is frequent use of the words "unanticipated problems." There are various things that could be unanticipated problems; some of them are also adverse events. In "Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs" that can be found on the FDA website, "...an AE observed during the conduct of a study should be considered an unanticipated problem involving risk to human subjects, and reported to the IRB, only if it were unexpected, serious, and would have implications for the conduct of the study (e.g., requiring a significant and usually safety-related, change in the protocol such as revising inclusion/exclusion criteria or including a new monitoring requirement, informed consent or investigator’s brochure). An individual AE occurrence ordinarily does not meet these criteria."
"In summary, FDA believes that only the following AEs should be considered as unanticipated problems that must be reported to the IRB:
"In comparison, prolonged neutropenia and opportunistic infections occurring in subjects administered an experimental chemotherapy regimen as part of an oncology trial would be examples of expected adverse events if the protocol described prolonged severe neutropenia and opportunistic infections as common risks for subjects." These events would not need to be reported to the IRB.
As stated, Liberty will be sending several regulatory update emails over the next few weeks. We hope you will find them helpful.
Please let us know if you have further questions about this!