1. B
CRCs manage daily site operations, scheduling, and data collection, not designing drugs or analyzing final statistics.
2. B
21 CFR Part 50 outlines requirements for protection of human subjects in clinical trials.
3. B
Informed consent must be obtained before any research-related procedures.
4. C
Mild headaches are not SAEs, unlike hospitalization, congenital anomalies, or death.
5. B
Source documents are where data are first recorded (e.g., medical charts, lab results).
6. C
Study visit checklists help CRCs track subject visits and procedures.
7. C
The PI has ultimate responsibility, though CRCs assist significantly.
8. C
Trial Master File (TMF) contains essential documents for evaluation.
9. B
Protocol deviations must be documented and reported per SOPs.
10. A
Monitoring ensures data quality and compliance.
11. C
IRB approval is required before implementing changes that affect safety.
12. A
Investigator’s Brochure contains safety and efficacy data for the investigational product.
13. B
Double-blind means both subject and investigator are unaware of treatment assignments.
14. A
Drug accountability logs ensure investigational product traceability.
15. B
New safety information requires updated consent.
16. B
CRCs cannot perform physical exams; this is a physician responsibility.
17. B
DSMBs review cumulative safety and efficacy data to ensure subject safety.
18. B
Queries should be resolved by verifying source documents.
19. B
Randomization assigns treatment by chance to minimize bias.
20. C
Subject initials with DOB are identifiable under HIPAA.
21. B
Documentation must be legible, signed, dated, and contemporaneous.
22. B
All adverse events must be recorded and reported as required.
23. B
Screening logs track all approached subjects and enrollment status.
24. B
Prisoners are considered vulnerable due to limited autonomy.
25. B
Subject’s withdrawal must be respected and documented.
26. A
Section 4 of ICH GCP outlines investigator responsibilities.
27. B
All essential documents must be inspection-ready and organized.
28. A
Form 1572 documents PI’s agreement to comply with FDA requirements.
29. A
Voluntariness of participation is essential in informed consent.
30. A
Not following fasting requirements is a protocol deviation.
31. B
Outreach strategies support recruitment; over-enrolling or altering criteria is not allowed.
32. B
Proper correction involves single-line strike-through, date, initial, correction.
33. B
Delegation log documents staff roles and responsibilities.
34. D
All listed monitoring types support compliance, depending on study design.
35. B
Temperature logs ensure compliance with protocol storage requirements.
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