CCRA® — Certified Clinical Research Associate - CCRA® — Certified Clinical Research Associate

Question 1

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

An SAE is any adverse event reported by the subject An SAE results in death, is life-threatening, requires hospitalization, results in disability, or involves a congenital anomaly An SAE must always be caused by the investigational product An SAE requires statistical significance to be classified as serious

Correct Answer:

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

Question 2

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

Within 30 days of occurrence Immediately, typically within 24 hours of learning of the event At the next scheduled monitoring visit Only if the event is considered related to the study drug

Correct Answer:

Immediately, typically within 24 hours of learning of the event

Question 3

The term 'expectedness' in safety reporting refers to:

Whether the adverse event was anticipated by the subject Whether the adverse event is listed in the Investigator Brochure or product labeling The probability that the adverse event will recur Whether the subject gave prior consent for the risk

Correct Answer:

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

Question 4

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

Serious, unexpected, and possibly related to the investigational product Serious, severe, and occurring in more than one subject Unexpected, life-threatening, and causing hospitalization only Related, unexpected, and non-serious

Correct Answer:

Serious, unexpected, and possibly related 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?

The investigator's assessment always overrides the sponsor's Both assessments should be reported, with the sponsor reporting based on the more conservative (related) assessment The event does not need to be reported if the investigator disagrees A data safety monitoring board must resolve all discrepancies before reporting

Correct Answer:

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

Exam overview

About this Exam

Prepare with the CCRA® — Certified Clinical Research Associate practice quiz. This question bank includes 30 questions covering clinical, research, visit, monitoring, and data. Use it to review important concepts, identify knowledge gaps, and build confidence for the related exam, course, or assessment.

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CCRA® — Certified Clinical Research Associate

This practice set contains 30 questions from the matching question bank and focuses on clinical, research, visit, monitoring, and data. Work through each question carefully, review the provided solutions, and revisit topics that need more study before your next attempt.

This is an independent study resource intended for practice and review; it is not an official examination or an endorsement by any organization named in the title.

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About this Exam

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CCRA® — Certified Clinical Research Associate

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