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CCRA® — Certified Clinical Research Associate

125 questions 5.0 rating Mobile friendly
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About this Exam

Prepare with the CCRA® — Certified Clinical Research Associate practice quiz. This question bank includes 125 questions covering clinical, site, visit, data, and trial. Use it to review important concepts, identify knowledge gaps, and build confidence for the related exam, course, or assessment.

Sample Questions

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
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
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
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
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

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Additional Information

CCRA® — Certified Clinical Research Associate

This practice set contains 125 questions from the matching question bank and focuses on clinical, site, visit, data, and trial. 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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Frequently Asked Questions

This quiz contains a total of 125 practice questions carefully selected to test your knowledge on this subject.
Yes, you will have exactly 0 minutes to complete the exam. A countdown timer will be visible once you start.
Yes, you can retake this practice test as many times as you need. The questions and options may be randomized on subsequent attempts to ensure comprehensive learning.

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