Adverse Event Management Flashcards

What distinguishes a Serious Adverse Event (SAE) from a non-serious adverse event?

Answer: An SAE results in death, is life-threatening, requires hospitalization, results in disability, or involves a congenital anomaly

An SAE meets at least one of the seriousness criteria defined in ICH E2A: death, life-threatening, inpatient hospitalization, persistent disability, congenital anomaly, or other medically important event.

Under ICH E6(R2), an investigator must report a serious adverse event to the sponsor:

Answer: Immediately, typically within 24 hours of learning of the event

ICH E6(R2) section 4.11.1 requires investigators to report SAEs to the sponsor immediately upon learning of the event, except for SAEs exempted in the protocol.

The term 'expectedness' in safety reporting refers to:

Answer: Whether the adverse event is listed in the Investigator Brochure or product labeling

Expectedness is determined by comparing the adverse event to events described in the reference safety information, typically the Investigator Brochure for investigational products.

A 'SUSAR' stands for Suspected Unexpected Serious Adverse Reaction and must meet which THREE criteria?

Answer: Serious, unexpected, and possibly related to the investigational product

A SUSAR must be serious (meets seriousness criteria), unexpected (not in the IB), and have a reasonable suspected causal relationship to the investigational product.

When the investigator's causality assessment differs from the sponsor's (sponsor considers event related, investigator does not), how should the discrepancy be handled for regulatory reporting?

Answer: Both assessments should be reported, with the sponsor reporting based on the more conservative (related) assessment

Regulatory guidance requires that when sponsor and investigator causality assessments differ, both must be documented, and the more conservative (causally related) assessment governs regulatory reporting requirements.

Which form is used in the US to report individual safety reports (IND safety reports) to the FDA for clinical trials?

Answer: FDA Form 3500A (MedWatch)

FDA Form 3500A (MedWatch) is used by sponsors to submit IND safety reports to the FDA for serious, unexpected, and suspected adverse drug reactions during clinical trials.