Regulatory Guidelines and Compliance Flashcards
7 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Guidelines and Compliance flashcards as text
A risk-based monitoring (RBM) approach as described in ICH E6(R2) differs from traditional monitoring primarily by:
Answer: Focusing monitoring resources on critical data and processes with highest risk
RBM concentrates monitoring efforts on the most critical and highest-risk data and processes rather than applying uniform 100% SDV across all data points.
Under 21 CFR Part 312.62, investigators are required to retain records for clinical investigations for how long after the investigation is discontinued or completed?
Answer: 2 years
21 CFR Part 312.62 requires investigators to retain records for two years after a marketing application is approved or the investigation is discontinued, whichever is later.
A 'substantial protocol amendment' requiring prior regulatory approval would include which of the following changes?
Answer: Adding a new primary efficacy endpoint to the protocol
Adding a new primary efficacy endpoint materially changes the scientific basis of the study and constitutes a substantial amendment requiring regulatory review and approval.
The Belmont Report's principle of 'Justice' in human subjects research requires that:
Answer: Selection of research subjects is fair and burdens are not placed on vulnerable populations
The Belmont Report's Justice principle requires fair distribution of research burdens and benefits, ensuring vulnerable groups are not exploited as convenient research subjects.
Which scenario would trigger an IND safety report (IND Annual Report supplement) requirement under 21 CFR Part 312.32?
Answer: An unexpected fatal serious adverse event reasonably related to the investigational drug
Under 21 CFR Part 312.32, sponsors must submit expedited IND safety reports for unexpected fatal or life-threatening serious adverse drug reactions.
In a double-blind randomized controlled trial, the 'blind' is considered 'broken' when:
Answer: The treatment assignment of a subject is revealed before unblinding
An unplanned revelation of a subject's treatment assignment before the protocol-specified unblinding date constitutes a protocol deviation known as an unblinding or broken blind.
The Mutual Recognition Agreement (MRA) between the US FDA and the European Union allows for:
Answer: Reciprocal recognition of GMP inspection results for pharmaceutical manufacturers
The FDA-EU MRA on pharmaceutical GMP allows each authority to rely on the other's manufacturing site inspection results rather than duplicating inspections.