CRA CRA Adverse Event Reporting & Safety Monitoring 1

Question 1

According to ICH E6(R2), what is the definition of a Serious Adverse Event (SAE)?

Accepted Answer

Any untoward medical occurrence that results in death, hospitalization, disability, or is life-threatening

Answer

ICH E6(R2) defines an SAE as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization, results in persistent disability, or is a congenital anomaly.

Question 2

Under FDA regulations (21 CFR 312.32), within what timeframe must a sponsor report a fatal or life-threatening unexpected serious adverse drug reaction (SUSAR) to the FDA?

Accepted Answer

Within 7 calendar days

Answer

Fatal or life-threatening unexpected serious adverse drug reactions must be reported to the FDA within 7 calendar days of the sponsor first receiving notice.

Question 3

What distinguishes an 'unexpected' adverse drug reaction from an 'expected' one in a clinical trial?

Accepted Answer

An unexpected ADR is not consistent in nature or severity with the investigator's brochure

Answer

An adverse drug reaction is 'unexpected' when its nature, severity, or frequency is not consistent with the information in the Investigator's Brochure (IB) or current product labeling.

Question 4

Which regulatory document is the investigator's primary reference for assessing whether an SAE is expected or unexpected?

Accepted Answer

The Investigator's Brochure (IB)

Answer

The Investigator's Brochure contains all known safety and efficacy information about the investigational product and serves as the reference for expectedness assessment.

Question 5

In a clinical trial, what is the primary responsibility of a Data Safety Monitoring Board (DSMB)?

Accepted Answer

To independently review accumulating safety and efficacy data and recommend stopping or continuing the trial

Answer

A DSMB independently reviews unblinded accumulating data to safeguard participant safety and ensure trial integrity, with authority to recommend stopping the trial.

(CRA) Certified Research Associate Practice Test

(CRA) Certified Research Associate Practice Test

CRA CRA Adverse Event Reporting & Safety Monitoring 1