ACRP CCRC ACTUAL EXAM PREP/STUDY
GUIDE/MULTIPLE CHOICE REVISION QUESTIONS
1. Which of the following best describes the primary responsibility of a
Clinical Research Coordinator (CRC)?
A. Designing new clinical trials
B. Overseeing study sponsor budgets
C. Managing day-to-day operations of a clinical trial at the site
D. Approving new study drugs
Answer: C
Explanation: The CRC’s main duty is managing daily site-level activities
including subject recruitment, data collection, and ensuring compliance with the
study protocol.
2. Which document ensures participants are fully informed about the clinical
trial before participation?
A. Case Report Form
B. Informed Consent Form
C. Source Document
D. Investigator’s Brochure
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, ACRP CCRC ACTUAL EXAM PREP/STUDY
GUIDE/MULTIPLE CHOICE REVISION QUESTIONS
Answer: B
Explanation: The Informed Consent Form (ICF) outlines study details, risks, and
rights, ensuring voluntary participation.
3. Good Clinical Practice (GCP) is primarily intended to:
A. Reduce study costs
B. Protect participants and ensure data integrity
C. Simplify sponsor documentation
D. Replace FDA regulations
Answer: B
Explanation: GCP protects human subjects and ensures reliability and credibility
of collected data.
4. Which regulatory body oversees clinical trials in the United States?
A. CDC
B. WHO
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, ACRP CCRC ACTUAL EXAM PREP/STUDY
GUIDE/MULTIPLE CHOICE REVISION QUESTIONS
C. FDA
D. EMA
Answer: C
Explanation: The Food and Drug Administration (FDA) regulates and monitors
clinical trials in the U.S.
5. Source documentation refers to:
A. Original records of clinical findings and observations
B. Copies of patient records kept by the sponsor
C. Data summaries for regulatory submission
D. Investigator brochures
Answer: A
Explanation: Source documents are original data (lab reports, notes, etc.) used to
verify Case Report Form entries.
6. The purpose of an Institutional Review Board (IRB) is to:
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, ACRP CCRC ACTUAL EXAM PREP/STUDY
GUIDE/MULTIPLE CHOICE REVISION QUESTIONS
A. Approve drug manufacturing sites
B. Protect the rights and welfare of research subjects
C. Manage study finances
D. Prepare marketing materials
Answer: B
Explanation: The IRB reviews research protocols to ensure participant safety and
ethical compliance.
7. A protocol deviation occurs when:
A. The sponsor changes the drug dose
B. A procedure differs from the approved protocol
C. A participant withdraws consent
D. The FDA inspects the site
Answer: B
Explanation: Any unplanned or unauthorized change in study procedures is a
protocol deviation.
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GUIDE/MULTIPLE CHOICE REVISION QUESTIONS
1. Which of the following best describes the primary responsibility of a
Clinical Research Coordinator (CRC)?
A. Designing new clinical trials
B. Overseeing study sponsor budgets
C. Managing day-to-day operations of a clinical trial at the site
D. Approving new study drugs
Answer: C
Explanation: The CRC’s main duty is managing daily site-level activities
including subject recruitment, data collection, and ensuring compliance with the
study protocol.
2. Which document ensures participants are fully informed about the clinical
trial before participation?
A. Case Report Form
B. Informed Consent Form
C. Source Document
D. Investigator’s Brochure
1|Page
, ACRP CCRC ACTUAL EXAM PREP/STUDY
GUIDE/MULTIPLE CHOICE REVISION QUESTIONS
Answer: B
Explanation: The Informed Consent Form (ICF) outlines study details, risks, and
rights, ensuring voluntary participation.
3. Good Clinical Practice (GCP) is primarily intended to:
A. Reduce study costs
B. Protect participants and ensure data integrity
C. Simplify sponsor documentation
D. Replace FDA regulations
Answer: B
Explanation: GCP protects human subjects and ensures reliability and credibility
of collected data.
4. Which regulatory body oversees clinical trials in the United States?
A. CDC
B. WHO
2|Page
, ACRP CCRC ACTUAL EXAM PREP/STUDY
GUIDE/MULTIPLE CHOICE REVISION QUESTIONS
C. FDA
D. EMA
Answer: C
Explanation: The Food and Drug Administration (FDA) regulates and monitors
clinical trials in the U.S.
5. Source documentation refers to:
A. Original records of clinical findings and observations
B. Copies of patient records kept by the sponsor
C. Data summaries for regulatory submission
D. Investigator brochures
Answer: A
Explanation: Source documents are original data (lab reports, notes, etc.) used to
verify Case Report Form entries.
6. The purpose of an Institutional Review Board (IRB) is to:
3|Page
, ACRP CCRC ACTUAL EXAM PREP/STUDY
GUIDE/MULTIPLE CHOICE REVISION QUESTIONS
A. Approve drug manufacturing sites
B. Protect the rights and welfare of research subjects
C. Manage study finances
D. Prepare marketing materials
Answer: B
Explanation: The IRB reviews research protocols to ensure participant safety and
ethical compliance.
7. A protocol deviation occurs when:
A. The sponsor changes the drug dose
B. A procedure differs from the approved protocol
C. A participant withdraws consent
D. The FDA inspects the site
Answer: B
Explanation: Any unplanned or unauthorized change in study procedures is a
protocol deviation.
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