CCRA Certified Clinical Research Associate 2 — Questions and Answers
Question 1: During a routine monitoring visit, the CRA discovers that the site has been enrolling subjects who do not meet the inclusion criteria. What is the FIRST action the CRA should take?
- Immediately suspend the trial at the site
- Document the finding and discuss it with the investigator during the visit (Correct answer)
- Notify the IRB directly without informing the sponsor
- Withdraw the non-compliant subjects from the study
Correct answer: Document the finding and discuss it with the investigator during the visit
The CRA should document the protocol deviation and discuss it with the investigator to understand the root cause before escalating per the monitoring plan.
Question 2: Which ICH E6(R2) principle requires that each individual involved in conducting a trial should be qualified by education, training, and experience?
- Principle 2 — IRB oversight
- Principle 3 — qualified personnel (Correct answer)
- Principle 7 — confidentiality protection
- Principle 12 — data integrity
Correct answer: Principle 3 — qualified personnel
ICH E6(R2) Principle 3 specifies that all trial personnel must be qualified by education, training, and experience to perform their tasks.
Question 3: A subject's source document shows a glucose value of 450 mg/dL, but the CRF records 45 mg/dL. How should this discrepancy be handled?
- Correct the CRF using white-out and initial the change
- Issue a data query to the site to correct the CRF entry with a documented explanation (Correct answer)
- Accept the CRF value as the data was already entered
- Ask the investigator to re-draw the sample to get a new value
Correct answer: Issue a data query to the site to correct the CRF entry with a documented explanation
Transcription errors between source documents and CRFs must be resolved through a formal data query so the correction is auditable.
Question 4: Under FDA 21 CFR Part 312, the sponsor must notify the FDA of an IND safety report (IND Safety Report) within how many calendar days for unexpected fatal or life-threatening SUSARs?
- 7 calendar days (Correct answer)
- 15 calendar days
- 30 calendar days
- 45 calendar days
Correct answer: 7 calendar days
Fatal or life-threatening unexpected serious adverse reactions must be reported to the FDA within 7 calendar days of the sponsor's first knowledge.
Question 5: Which document is considered the primary source for verifying that informed consent was obtained before any study procedures were performed?
- The signed and dated informed consent form (Correct answer)
- The subject's enrollment log
- The protocol synopsis
- The investigator's brochure
Correct answer: The signed and dated informed consent form
The signed and dated informed consent form is the primary document confirming that consent was obtained prior to study participation.
Question 6: A CRA is reviewing the drug accountability log and notices that the quantity of investigational product dispensed does not reconcile with what subjects received. What should the CRA do?
- Adjust the log to make the numbers match
- Flag the discrepancy, discuss with the pharmacist or site coordinator, and document in the monitoring report (Correct answer)
- Destroy the unaccounted product immediately
- Report the site to the FDA without further investigation
Correct answer: Flag the discrepancy, discuss with the pharmacist or site coordinator, and document in the monitoring report
Drug accountability discrepancies must be investigated, discussed with site staff, and documented in the monitoring report to ensure chain of custody.
Question 7: When must the CRA ensure that the Trial Master File (TMF) is set up and accessible?
- Only after the first subject is enrolled
- Before the trial begins and maintained throughout the trial (Correct answer)
- After the database is locked
- Only during regulatory inspections
Correct answer: Before the trial begins and maintained throughout the trial
ICH E6(R2) requires the TMF to be established before the trial commences and maintained throughout the trial and post-trial period.
CCRA Certified Clinical Research Associate 2
During a routine monitoring visit, the CRA discovers that the site has been enrolling subjects who do not meet the inclusion criteria.
What is the FIRST action the CRA should take?