Free CCRA Practice Questions
Original questions with explanations
These original CCRA practice questions are educational examples designed to exercise reasoning. They are not recalled exam items and do not imply access to live or confidential test content.
Question 1
A monitor finds repeated late data entry at a site. What is the best first response?
- A. Delete the entries
- B. Document the finding, assess its cause and impact, and agree on corrective action
- C. Ignore it if values look plausible
- D. Enter data for the site
Answer and explanation
B. Document the finding, assess its cause and impact, and agree on corrective action Monitoring requires documented evaluation of noncompliance and proportionate corrective and preventive action.
Question 2
Which document records how a clinical trial will be conducted?
- A. Protocol
- B. Packing list
- C. Invoice
- D. Employment contract
Answer and explanation
A. Protocol The protocol defines the trial’s objectives, design, methodology, statistical considerations, and organization.
Question 3
When should informed consent generally be obtained?
- A. After study procedures
- B. Before participation in study-specific procedures
- C. Only after an adverse event
- D. At database lock
Answer and explanation
B. Before participation in study-specific procedures Valid informed consent precedes enrollment and study-specific procedures unless an applicable approved exception exists.
Question 4
A serious unexpected event may affect participant safety. What is the priority?
- A. Wait for routine monitoring
- B. Follow the protocol and applicable expedited safety-reporting pathways
- C. Remove the source record
- D. Change the protocol without approval
Answer and explanation
B. Follow the protocol and applicable expedited safety-reporting pathways Potentially reportable safety information must follow the established sponsor, ethics, and regulatory pathways.
Question 5
Which monitoring approach is most consistent with quality-by-design principles?
- A. Treat every data point as equally critical
- B. Focus oversight on critical-to-quality factors and meaningful risks
- C. Eliminate source review
- D. Avoid documenting risk decisions
Answer and explanation
B. Focus oversight on critical-to-quality factors and meaningful risks Risk-proportionate oversight focuses resources on factors important to participant protection and reliable results.
How to Review Your Results
For every missed item, name the tested concept, explain why the correct option is best, and identify the clue that rules out each distractor. Then review the corresponding official content domain.