MARYLAND CLINICAL RESEARCH COORDINATOR
CERTIFICATION EXAM QUESTIONS AND CORRECT
ANSWERS (VERIFIED ANSWERS) Q&A 2026
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1. What is the primary role of a Clinical Research Coordinator
(CRC)?
A. Perform surgery on trial patients
B. Manage day-to-day clinical trial operations
C. Manufacture investigational drugs
D. Approve FDA regulations
Rationale: CRCs handle study implementation and coordination
at site level.
Correct answer: B
2. What does GCP stand for?
A. Good Clinical Practice
B. Global Clinical Protocol
C. General Care Procedure
D. Good Compliance Policy
Rationale: GCP ensures ethical and scientific quality in trials.
Correct answer: A
3. Informed consent must be obtained:
A. After study completion
B. Before participation begins
C. Only for FDA audits
,D. After randomization
Rationale: Consent is required before any study procedures.
Correct answer: B
4. Who is responsible for protecting participant rights?
A. Sponsor
B. CRC
C. IRB
D. Pharmacy
Rationale: IRB ensures participant safety and rights.
Correct answer: C
5. Adverse event (AE) means:
A. Positive lab result
B. Any unfavorable medical occurrence
C. Study success
D. Drug approval
Rationale: AE includes any negative medical event during study.
Correct answer: B
6. Serious adverse event (SAE) includes:
A. Mild headache
B. Life-threatening event
C. Slight fatigue
D. Normal lab value
Rationale: SAEs include death, hospitalization, or risk of death.
Correct answer: B
7. Randomization is used to:
A. Bias results
, B. Assign participants by chance
C. Exclude participants
D. Speed drug approval
Rationale: Ensures unbiased group assignment.
Correct answer: B
8. Blinding in clinical trials reduces:
A. Cost
B. Bias
C. Enrollment
D. Data collection
Rationale: Prevents influence from knowledge of treatment.
Correct answer: B
9. Source documents are:
A. Marketing materials
B. Original patient records
C. FDA forms only
D. Protocol summaries
Rationale: They verify trial data accuracy.
Correct answer: B
10. Protocol deviations must be:
A. Ignored
B. Documented
C. Deleted
D. Hidden
Rationale: All deviations require documentation.
Correct answer: B
CERTIFICATION EXAM QUESTIONS AND CORRECT
ANSWERS (VERIFIED ANSWERS) Q&A 2026
|INSTANT DOWNLOAD PDF
1. What is the primary role of a Clinical Research Coordinator
(CRC)?
A. Perform surgery on trial patients
B. Manage day-to-day clinical trial operations
C. Manufacture investigational drugs
D. Approve FDA regulations
Rationale: CRCs handle study implementation and coordination
at site level.
Correct answer: B
2. What does GCP stand for?
A. Good Clinical Practice
B. Global Clinical Protocol
C. General Care Procedure
D. Good Compliance Policy
Rationale: GCP ensures ethical and scientific quality in trials.
Correct answer: A
3. Informed consent must be obtained:
A. After study completion
B. Before participation begins
C. Only for FDA audits
,D. After randomization
Rationale: Consent is required before any study procedures.
Correct answer: B
4. Who is responsible for protecting participant rights?
A. Sponsor
B. CRC
C. IRB
D. Pharmacy
Rationale: IRB ensures participant safety and rights.
Correct answer: C
5. Adverse event (AE) means:
A. Positive lab result
B. Any unfavorable medical occurrence
C. Study success
D. Drug approval
Rationale: AE includes any negative medical event during study.
Correct answer: B
6. Serious adverse event (SAE) includes:
A. Mild headache
B. Life-threatening event
C. Slight fatigue
D. Normal lab value
Rationale: SAEs include death, hospitalization, or risk of death.
Correct answer: B
7. Randomization is used to:
A. Bias results
, B. Assign participants by chance
C. Exclude participants
D. Speed drug approval
Rationale: Ensures unbiased group assignment.
Correct answer: B
8. Blinding in clinical trials reduces:
A. Cost
B. Bias
C. Enrollment
D. Data collection
Rationale: Prevents influence from knowledge of treatment.
Correct answer: B
9. Source documents are:
A. Marketing materials
B. Original patient records
C. FDA forms only
D. Protocol summaries
Rationale: They verify trial data accuracy.
Correct answer: B
10. Protocol deviations must be:
A. Ignored
B. Documented
C. Deleted
D. Hidden
Rationale: All deviations require documentation.
Correct answer: B
