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.