BMAT Regulatory Frameworks & Compliance 3

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?

Accepted Answer

Expedited review

Answer

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?

Accepted Answer

A surrogate endpoint reasonably likely to predict clinical benefit

Answer

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?

Accepted Answer

€20 million or 4% of global annual turnover, whichever is higher

Answer

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?

Accepted Answer

The Federal Food, Drug, and Cosmetic Act (FD&C Act) as enforced by FDA

Answer

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?

Accepted Answer

Report to all relevant regulatory authorities, the IRB/IEC, and ensure participants are informed and safely transitioned

Answer

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.

BMAT - Assessment Practice Test

BMAT - Assessment Practice Test

BMAT Regulatory Frameworks & Compliance 3