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
A research administrator reviewing a budget discovers the protocol requires a specialized pharmacy preparation not covered in the sponsor's per-visit fee. The administrator should:
Answer: Negotiate a budget amendment with the sponsor to cover the pharmacy preparation cost
Uncovered pharmacy preparation costs must be negotiated into the study budget through a contract amendment to ensure financial sustainability and compliance.
A Phase III oncology trial uses a placebo controlled design. The placebo must be:
Answer: Manufactured and labeled to be indistinguishable from the active drug in appearance and packaging
Placebos must be manufactured and labeled to match the active drug's appearance and packaging to maintain blinding integrity.
Under 21 CFR Part 312, which of the following is NOT an investigator obligation related to investigational drugs?
Answer: Manufacturing the drug at the clinical site
Investigators are not responsible for manufacturing investigational drugs; that obligation falls on the sponsor under GMP requirements.
A CRA discovers that the site has been storing the liquid investigational drug in a light-exposed area contrary to protocol storage requirements. This is best categorized as:
Answer: A protocol deviation affecting drug integrity
Improper storage conditions violate protocol requirements and constitute a protocol deviation that may compromise drug integrity and subject safety.
During a routine FDA inspection, inspectors request all drug accountability records for the past three years. The minimum retention period for such records under 21 CFR Part 312 after study completion is:
Answer: 2 years
Under 21 CFR 312.62(c), drug disposition records must be retained for 2 years after marketing approval or 2 years after the IND is discontinued.
A study subject experiences an unexpected serious adverse event that the investigator believes may be related to the investigational drug. The IND sponsor's timeline to report this to the FDA as an IND Safety Report is:
Answer: Within 7 calendar days if fatal or life-threatening; within 15 calendar days for others
21 CFR 312.32 requires fatal or life-threatening unexpected serious adverse events to be reported within 7 days; other unexpected serious adverse events within 15 days.
Which of the following best describes a 'comparator drug' in a clinical trial?
Answer: An approved or investigational drug used as a reference treatment against which the study drug is compared
A comparator drug serves as the reference arm (active control or standard of care) against which the investigational drug's safety and efficacy are evaluated.