BMAT Regulatory Frameworks & Compliance 3 — Questions and Answers
Question 1: An IRB (Institutional Review Board) is reviewing a study that poses minimal risk to participants. Under the Common Rule, this study may qualify for which type of review?
- Full board review
- Expedited review (Correct answer)
- Exempt review determination
- Conditional approval
Correct answer: Expedited review
Studies posing no more than minimal risk that fall into specific regulatory categories may qualify for expedited review by the IRB chair or a designated reviewer rather than the full board.
Question 2: The FDA's Accelerated Approval pathway allows drugs for serious conditions to be approved based on which type of endpoint?
- A surrogate endpoint reasonably likely to predict clinical benefit (Correct answer)
- A confirmed clinical benefit endpoint from a Phase III trial
- Patient-reported quality of life outcomes only
- Economic cost-effectiveness data
Correct answer: A surrogate endpoint reasonably likely to predict clinical benefit
Accelerated Approval is granted based on a surrogate or intermediate clinical endpoint reasonably likely to predict clinical benefit, with confirmatory post-approval trials required.
Question 3: Under EU GDPR, what is the maximum fine for a serious data protection violation by a large organization?
- €10 million or 2% of global annual turnover, whichever is higher
- €20 million or 4% of global annual turnover, whichever is higher (Correct answer)
- €5 million or 1% of EU revenue, whichever is lower
- Fines are capped at €50 million regardless of company size
Correct answer: €20 million or 4% of global annual turnover, whichever is higher
GDPR Article 83(5) allows fines of up to €20 million or 4% of total worldwide annual turnover of the preceding financial year, whichever is higher, for the most serious infringements.
Question 4: Which regulatory framework governs the safety and performance of medical devices sold in the United States?
- The Drug Approval Act (DAA)
- The Federal Food, Drug, and Cosmetic Act (FD&C Act) as enforced by FDA (Correct answer)
- The Medical Device Regulation (MDR) — an EU regulation
- The Consumer Product Safety Act exclusively
Correct answer: The Federal Food, Drug, and Cosmetic Act (FD&C Act) as enforced by FDA
The FD&C Act (particularly as amended by the Medical Device Amendments of 1976) provides the statutory basis for FDA regulation of medical devices in the U.S.
Question 5: A sponsor terminates a clinical trial early due to unexpected safety findings. Under GCP, what is the primary obligation?
- Notify only the FDA; IRB notification is optional
- Report to all relevant regulatory authorities, the IRB/IEC, and ensure participants are informed and safely transitioned (Correct answer)
- Keep the termination confidential until a replacement study is designed
- Only notify participants who experienced the adverse events
Correct answer: Report to all relevant regulatory authorities, the IRB/IEC, and ensure participants are informed and safely transitioned
GCP requires that early termination be reported to all regulatory authorities, the IRB/IEC, and that enrolled participants receive appropriate follow-up care and notification.
Question 6: The Declaration of Helsinki is primarily directed at which group?
- Government health ministries setting national drug policy
- Physicians and other medical researchers conducting human research (Correct answer)
- Pharmaceutical companies seeking marketing authorization
- Hospital administrators managing clinical operations
Correct answer: Physicians and other medical researchers conducting human research
The Declaration of Helsinki, issued by the World Medical Association, provides ethical principles specifically for physicians and researchers involved in medical research with human subjects.
Question 7: A Class III medical device in the U.S. (e.g., an implantable cardiac pacemaker) typically requires which FDA pathway before market entry?
- 510(k) premarket notification
- Premarket Approval (PMA) (Correct answer)
- De Novo classification request
- Humanitarian Device Exemption (HDE)
Correct answer: Premarket Approval (PMA)
Class III devices that support life, prevent impairment of health, or present unreasonable risk require Premarket Approval (PMA), the most stringent FDA device pathway requiring clinical evidence of safety and effectiveness.
BMAT Regulatory Frameworks & Compliance 3
An IRB (Institutional Review Board) is reviewing a study that poses minimal risk to participants.
Under the Common Rule, this study may qualify for which type of review?