The FDA's final rule on safety reporting requirements during clinical trials, announced on Tuesday, requires certain information previously not required to now be reported within 15 days. The rule also lifts the requirement to report all serious adverse events and instead offers guidelines on when a single event needs to be reported.
Among the information now required within 15 days of occurrence is trial and epidemiological findings that suggest "a significant risk to study participants," says an FDA announcement. Also included is information on serious suspected adverse reactions that occur at a rate higher than expected and information on serious adverse events from bioavailability studies that determine drug absorption characteristics. Bioequivalence study data is also among the newly required information.
The final rule eliminates the long-standing requirement for researchers to report all serious adverse events, even those whose evidence suggests a cause other than the drug candidate. Instead, the rule guides researchers on when a single event should be reported or when there is need to wait for more than one occurrence.
Along with this final rule, the FDA issued draft guidance that provides information and advice about the new requirements.
- see the FDA release
- here's the final rule