FDA's guidance addresses adverse reporting of items
FDA's guidance addresses adverse reporting of items
Here's FDA advice in nutshell
In April, 2007, the Food and Drug Administration (FDA) issued its draft "Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting — Improving Human Subject Protection."
The guidance addresses IRB concerns about how investigators and sponsors interpret regulatory requirements about reporting unanticipated problems.
"IRBs note that they receive increasingly large volumes of individual adverse event reports — often lacking in context and detail — that are inhibiting their ability to assure the protection of human subjects," the draft guidance states.
"IRBs reported difficulties in reviewing and interpreting the significance of information when large volumes of individual adverse event reports are received in isolation (neither aggregated nor analyzed) at sporadic intervals during the course of a study," the guidance says.
The FDA recommendations in the draft guidance are as follows:
- Investigators must notify IRBs of unanticipated problems, which are not the same as adverse events. "FDA believes that an individual adverse event report cannot be readily concluded to represent an unanticipated problem, even if the event is not addressed in the investigator's brochure, protocol, or informed consent documents," the guidance says.
- In multi-center studies, investigators must rely on the sponsor to provide them with information about adverse experiences occurring at other study sites. "We recognize that for multi-center studies, the sponsor is in a better position to process and analyze adverse event information for the entire study, and to assess whether an occurrence is both 'unanticipated' and a 'problem' for the study," the guidance states.
- Investigators studying devices must submit a report of a UADE to the sponsor and the reviewing IRB as soon as possible and not any later than 10 working days after the investigator first learns of the event, the guidance says.
The FDA draft guidance offers these examples of when adverse experiences should be reported to the IRB as unanticipated problems:
- "Any adverse experience that, even without detailed analysis, represents a serious unexpected adverse event that is rare in the absence of drug exposure (such as agranulocytosis, hepatic necrosis, Stevens-Johnson syndrome)."
- "A series of adverse events that, on analysis, is both unanticipated and a problem for the study. There would be a determination that the series of adverse events represents a signal that the adverse events were not just isolated occurrences and were significant to the rights and welfare of subjects. We recommend that a summary and analyses supporting the conclusion accompany the report."
- "An adverse event that is described or addressed in the investigator's brochure, protocol, or informed consent documents, or expected to occur in study subjects at an anticipated rate (e.g., expected progression of disease, occurrence of events consistent with background rate in subject population), but that occurs at a greater frequency or at greater severity than expected. We recommend that a discussion of the divergence from expected rates accompany the report."
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.