Adverse Event Safety Reporting Flashcards

According to FDA regulations (21 CFR 312.32), which of the following outcomes makes an adverse event classified as 'serious'?

Answer: Results in persistent or significant disability or incapacity

An SAE is one that results in death, is life-threatening, requires inpatient hospitalization, causes persistent or significant disability, is a congenital anomaly, or is medically significant.

An investigator must report a serious adverse event (SAE) to the sponsor within what timeframe per ICH E6 GCP guidelines?

Answer: Within 24 hours of awareness

ICH E6 requires investigators to report SAEs to the sponsor promptly, typically within 24 hours of first awareness of the event.

Which FDA form is used by sponsors to submit expedited IND safety reports (individual case safety reports) to the agency?

Answer: FDA Form 3500A (MedWatch)

FDA Form 3500A (MedWatch) is the mandatory reporting form used for expedited IND safety reports submitted to the FDA.

In the context of adverse event reporting, an event is considered 'unexpected' when:

Answer: Its nature, severity, or frequency is not consistent with the Investigator's Brochure

An unexpected adverse reaction is one whose nature, severity, specificity, or outcome is not consistent with what is described in the current Investigator's Brochure (IB).

A sponsor must report a fatal or life-threatening unexpected suspected adverse reaction (SUSAR) to the FDA within:

Answer: 7 calendar days

Fatal or life-threatening SUSARs must be reported to the FDA within 7 calendar days of the sponsor's initial awareness under 21 CFR 312.32(c)(2).

Which element is required to classify an adverse event as a 'suspected adverse reaction' rather than a general AE?

Answer: There is a reasonable possibility that the investigational drug caused the event

A suspected adverse reaction requires a reasonable possibility of a causal relationship between the investigational drug and the adverse event, as assessed by the investigator or sponsor.

Under 21 CFR 312.32, non-fatal, non-life-threatening unexpected SUSARs must be reported to the FDA within:

Answer: 15 calendar days

Non-fatal, non-life-threatening unexpected SUSARs must be reported to the FDA within 15 calendar days of the sponsor's first awareness.