Reporting To The IRB: Serious Adverse Events (SAEs) In Drug Studies

By Lauri Carlile, Vice President, Operations

In 2009, the Food and Drug Administration (FDA) released a guidance document on adverse event (AE) reporting to IRBs, which is intended to “assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports” to the IRB.

For research conducted under an investigational new drug (IND), the guidance states:

• Investigators are required to report promptly “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(b)).
• Sponsors are specifically required to notify all participating investigators (and FDA) in a written IND safety report of “any adverse experience associated with the use of the drug that is both serious and unexpected” and “any finding from tests in laboratory animals that suggests a significant risk for human subjects” (21 CFR 312.32(c)(1)(i)(A),(B)).
  • And, more generally, sponsors are required to “keep each participating investigator informed of new observations discovered by or reported to the sponsor on the drug, particularly with respect to adverse effects and safe use” (21 CFR 312.55(b)).
• Investigators are required to report promptly “to the IRB… all unanticipated problems involving risks to human subjects or others,” including adverse events that should be considered unanticipated problems (21 CFR 56.108(b)(1), 21 CFR 312.53(c)(1)(vii), and 21 CFR 312.66).

So what does this mean in practice?