MARYLAND CLINICAL RESEARCH ASSOCIATE
CERTIFICATION EXAM QUESTIONS AND CORRECT
ANSWERS (VERIFIED ANSWERS) Q&A 2026
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Q1. What is the primary role of a Clinical Research Associate
(CRA)?
A) Patient diagnosis
B) Monitoring clinical trial compliance
C) Prescribing medication
D) Performing surgery
Rationale: CRAs ensure trials follow protocol and regulations.
Correct answer: B
Q2. What guideline governs ethical clinical trials globally?
A) HIPAA
B) GCP (Good Clinical Practice)
C) OSHA
D) FDA Form 1572
Rationale: GCP ensures ethical and scientific quality standards.
Correct answer: B
Q3. Informed consent must be obtained:
A) After treatment
B) Before enrollment
C) Only for minors
D) After data collection
,Rationale: Consent is required before participation.
Correct answer: B
Q4. What is source data in clinical research?
A) Published journals
B) Original trial records
C) Marketing materials
D) Statistical summaries
Rationale: Source data is original recorded information.
Correct answer: B
Q5. What does protocol deviation mean?
A) Planned change
B) Unauthorized departure from protocol
C) Data analysis
D) Regulatory approval
Rationale: Deviations violate protocol requirements.
Correct answer: B
Q6. Who approves clinical trial protocols?
A) CRA
B) IRB/IEC
C) Nurse
D) Pharmacist
Rationale: IRB ensures ethical approval.
Correct answer: B
Q7. What is the purpose of monitoring visits?
A) Marketing trial
B) Ensure compliance and data accuracy
, C) Recruit patients
D) Replace investigators
Rationale: Monitoring ensures quality and compliance.
Correct answer: B
Q8. What does SAE stand for?
A) Standard Adverse Event
B) Serious Adverse Event
C) Systemic Analysis Event
D) Safety Assessment Evaluation
Rationale: SAE refers to serious medical incidents.
Correct answer: B
Q9. Which document defines study procedures?
A) Consent form
B) Study protocol
C) Invoice
D) Resume
Rationale: Protocol outlines procedures.
Correct answer: B
Q10. What is essential for regulatory compliance?
A) Advertising
B) Documentation
C) Guessing results
D) Verbal reports only
Rationale: Documentation ensures traceability.
Correct answer: B
CERTIFICATION EXAM QUESTIONS AND CORRECT
ANSWERS (VERIFIED ANSWERS) Q&A 2026
|INSTANT DOWNLOAD PDF
Q1. What is the primary role of a Clinical Research Associate
(CRA)?
A) Patient diagnosis
B) Monitoring clinical trial compliance
C) Prescribing medication
D) Performing surgery
Rationale: CRAs ensure trials follow protocol and regulations.
Correct answer: B
Q2. What guideline governs ethical clinical trials globally?
A) HIPAA
B) GCP (Good Clinical Practice)
C) OSHA
D) FDA Form 1572
Rationale: GCP ensures ethical and scientific quality standards.
Correct answer: B
Q3. Informed consent must be obtained:
A) After treatment
B) Before enrollment
C) Only for minors
D) After data collection
,Rationale: Consent is required before participation.
Correct answer: B
Q4. What is source data in clinical research?
A) Published journals
B) Original trial records
C) Marketing materials
D) Statistical summaries
Rationale: Source data is original recorded information.
Correct answer: B
Q5. What does protocol deviation mean?
A) Planned change
B) Unauthorized departure from protocol
C) Data analysis
D) Regulatory approval
Rationale: Deviations violate protocol requirements.
Correct answer: B
Q6. Who approves clinical trial protocols?
A) CRA
B) IRB/IEC
C) Nurse
D) Pharmacist
Rationale: IRB ensures ethical approval.
Correct answer: B
Q7. What is the purpose of monitoring visits?
A) Marketing trial
B) Ensure compliance and data accuracy
, C) Recruit patients
D) Replace investigators
Rationale: Monitoring ensures quality and compliance.
Correct answer: B
Q8. What does SAE stand for?
A) Standard Adverse Event
B) Serious Adverse Event
C) Systemic Analysis Event
D) Safety Assessment Evaluation
Rationale: SAE refers to serious medical incidents.
Correct answer: B
Q9. Which document defines study procedures?
A) Consent form
B) Study protocol
C) Invoice
D) Resume
Rationale: Protocol outlines procedures.
Correct answer: B
Q10. What is essential for regulatory compliance?
A) Advertising
B) Documentation
C) Guessing results
D) Verbal reports only
Rationale: Documentation ensures traceability.
Correct answer: B
