Free SOCRA Practice Questions
Five original questions with explanations
These are original educational questions written to exercise SOCRA-relevant reasoning. They are not recalled examination items and do not imply access to confidential test content.
Question 1
A protocol deviation creates an immediate safety risk. What is the priority?
- A. Hide the deviation
- B. Protect the participant and follow reporting requirements
- C. Alter source records
- D. Wait for study closeout
Answer and explanation
B. Protect the participant and follow reporting requirements Participant safety and required escalation take priority.
Question 2
Which feature is essential to valid informed consent?
- A. Technical language only
- B. Voluntary agreement after understandable disclosure
- C. Enrollment before discussion
- D. Guaranteed benefit
Answer and explanation
B. Voluntary agreement after understandable disclosure Consent must be informed, understandable, and voluntary.
Question 3
Why must source data changes preserve an audit trail?
- A. To make records shorter
- B. To retain attributable and traceable data history
- C. To hide errors
- D. To avoid monitoring
Answer and explanation
B. To retain attributable and traceable data history Traceability supports data integrity and inspection readiness.
Question 4
An adverse event occurs. What determines reporting obligations?
- A. Personal preference
- B. Protocol, sponsor, IRB, regulatory, and institutional requirements
- C. Whether the visit was convenient
- D. The participant’s payment
Answer and explanation
B. Protocol, sponsor, IRB, regulatory, and institutional requirements Multiple governing requirements define assessment and reporting timelines.
Question 5
What best reduces selection bias?
- A. Changing eligibility after enrollment
- B. Applying prespecified criteria consistently
- C. Recruiting only easy participants
- D. Discarding inconvenient data
Answer and explanation
B. Applying prespecified criteria consistently Consistent application of prespecified criteria supports fair selection and interpretable results.
How to Review
For every miss, identify the domain, explain the controlling principle, and state why each distractor is less appropriate. Then return to the official outline and your content review.