Medication Management Oversight Flashcards
7 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Medication Management Oversight flashcards as text
Under 21 CFR Part 312, who is ultimately responsible for the proper conduct of an investigational drug study at a clinical site?
Answer: Principal Investigator
The Principal Investigator bears ultimate responsibility for the conduct of the study and proper use of investigational drugs at the site.
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?
Answer: 45 CFR Part 46
Administering investigational drugs before obtaining informed consent violates the human subjects protection requirements under 45 CFR Part 46.
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?
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.
When a blinded randomized trial requires emergency unblinding for a participant, who should typically be contacted first?
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.
Which document must be maintained to verify that all dispensed investigational drug quantities are accounted for at a clinical site?
Answer: Drug accountability log
The drug accountability log tracks dispensing, returns, and destruction, enabling reconciliation of all investigational product.
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:
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.
The double-blind packaging requirement in clinical trials primarily serves to:
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.