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An investigator shall promptly report to the sponsor any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming, the investigator shall report the adverse effect immediately (21 CFR 312.64). Guides to adverse event reporting are indicated below:
- Unexpected fatal or life-threatening suspected adverse reactions that are associated with the investigational drug must be reported to the FDA by fax or telephone as soon as possible, but no later than 7 calendar days after the sponsor-investigator initially receives the information.
- Serious and unexpected suspected adverse reactions associated with the use of the drug that are not fatal or life-threatening only if there is evidence to suggest a causal relationship between the drug and the adverse event. These must be submitted to the FDA as soon as possible, but no later than 15 days after the sponsor-investigator initially receives the information.
- Findings from other studies that suggests a significant risk in humans exposed to the drug whether or not conducted under an IND or not conducted by the sponsor-investigator. This includes any findings from epidemiological studies, pooled analysis of multiple studies, or clinical studies.
- Findings from animal or in vitro testing that suggests a significant risk in humans exposed to the drug whether or not conducted by the sponsor-investigator. This includes reports of mutagenicity, teratogenicity, or carcinogenicity, or reports of significant organ toxicity at or near the expected human exposure.
- Increased rate of occurrence of serious suspected adverse reactions that are a clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor should consider a variety of factors (study population, nature and seriousness of the reaction and the magnitude of the observed increase in rate).
- Additional information that must be included in each IND safety report including all IND safety reports previously submitted to the FDA concerning a similar suspected adverse reaction and the significance of the suspected adverse reaction in light of previous, similar reports or any other relevant information.