CCRA Adverse Event Management

Question 1

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

Accepted Answer

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

Answer

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.

Question 2

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

Accepted Answer

Immediately, typically within 24 hours of learning of the event

Answer

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.

Question 3

The term 'expectedness' in safety reporting refers to:

Accepted Answer

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

Answer

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

Question 4

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

Accepted Answer

Serious, unexpected, and possibly related to the investigational product

Answer

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

Question 5

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?

Accepted Answer

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

Answer

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.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Adverse Event Management