SOCRA Adverse Event Safety Reporting 2

Question 1

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

Accepted Answer

Results in persistent or significant disability or incapacity

Answer

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.

Question 2

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

Accepted Answer

Within 24 hours of awareness

Answer

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

Question 3

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

Accepted Answer

FDA Form 3500A (MedWatch)

Answer

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

Question 4

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

Accepted Answer

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

Answer

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).

Question 5

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

Accepted Answer

7 calendar days

Answer

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).

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Adverse Event Safety Reporting 2