CRA Medication Management Oversight 2 — Questions and Answers
Question 1: Under 21 CFR Part 312, who is ultimately responsible for the proper conduct of an investigational drug study at a clinical site?
- Sponsor-monitor
- Principal Investigator (Correct answer)
- IRB Chair
- Research Pharmacist
Correct answer: Principal Investigator
The Principal Investigator bears ultimate responsibility for the conduct of the study and proper use of investigational drugs at the site.
Question 2: A sponsor notices an investigational site is dispensing the study drug to subjects before receiving signed informed consent. This is primarily a violation of which regulation?
- 21 CFR Part 211
- 21 CFR Part 312.62
- 45 CFR Part 46 (Correct answer)
- 21 CFR Part 58
Correct answer: 45 CFR Part 46
Administering investigational drugs before obtaining informed consent violates the human subjects protection requirements under 45 CFR Part 46.
Question 3: A research pharmacist discovers that temperature logs for a biologic study drug show two days of out-of-range storage. What is the most appropriate immediate action?
- Discard the drug and resume with new supply
- Continue using the drug and note the deviation
- Quarantine the affected lot and notify the sponsor (Correct answer)
- Adjust the logs to reflect acceptable temperatures
Correct answer: Quarantine the affected lot and notify the sponsor
Out-of-range storage requires quarantining the affected product and promptly notifying the sponsor for stability assessment.
Question 4: When a blinded randomized trial requires emergency unblinding for a participant, who should typically be contacted first?
- The IRB
- The data safety monitoring board
- The sponsor or designated emergency unblinding contact (Correct answer)
- The participant's primary care physician
Correct answer: The sponsor or designated emergency unblinding contact
Sponsors establish emergency unblinding procedures and should be contacted first through the designated 24-hour contact or code-break envelope process.
Question 5: Which document must be maintained to verify that all dispensed investigational drug quantities are accounted for at a clinical site?
- Delegation of authority log
- Drug accountability log (Correct answer)
- Subject enrollment log
- Adverse event narrative
Correct answer: Drug accountability log
The drug accountability log tracks dispensing, returns, and destruction, enabling reconciliation of all investigational product.
Question 6: A CRA reviewing site records finds a subject received a higher dose than the protocol specified due to a dispensing error. Under GCP, this constitutes a:
- Minor protocol deviation requiring local documentation only
- Protocol deviation that must be reported to the IRB and sponsor (Correct answer)
- Adverse event that can be captured at the next monitoring visit
- Good documentation practice failure only
Correct answer: Protocol deviation that must be reported to the IRB and sponsor
A dosing error that deviates from the approved protocol must be reported promptly to both the sponsor and IRB per GCP requirements.
Question 7: The double-blind packaging requirement in clinical trials primarily serves to:
- Reduce manufacturing costs
- Prevent allocation bias and maintain study integrity (Correct answer)
- Simplify pharmacy dispensing workflows
- Comply with DEA Schedule II labeling rules
Correct answer: Prevent allocation bias and maintain study integrity
Double-blind packaging ensures neither the subject nor the investigator can identify treatment assignment, preventing performance and detection bias.
CRA Medication Management Oversight 2
Under 21 CFR Part 312, who is ultimately responsible for the proper conduct of an investigational drug study at a clinical site?