RAC Premarketing and Clinical Development 3

Question 1

Which element is NOT required in an informed consent document under 21 CFR Part 50?

Accepted Answer

Identification of the sponsor's legal counsel

Answer

21 CFR 50.25 lists required elements of informed consent; identifying the sponsor's legal counsel is not among them.

Question 2

Under the Common Rule (45 CFR Part 46), which category of research qualifies for exemption from full IRB review?

Accepted Answer

Survey research involving adults where responses are recorded anonymously

Answer

Anonymous survey research involving adults falls under Common Rule Category 2 exemption when disclosure cannot reasonably place subjects at risk.

Question 3

A company plans to use a validated biomarker as a primary endpoint in a Phase II trial to support dose selection. What FDA pathway provides formal endorsement of this biomarker's use?

Accepted Answer

Biomarker Qualification Program

Answer

FDA's Biomarker Qualification Program formally evaluates and endorses a biomarker for a specific context of use in drug development.

Question 4

According to ICH E9(R1), what does the estimand framework primarily help clinical trial designers specify?

Accepted Answer

The precise clinical question a trial is intended to answer, including how intercurrent events are handled

Answer

ICH E9(R1) introduced the estimand framework to align the trial objective, design, and analysis by explicitly defining the treatment effect of interest and handling of intercurrent events.

Question 5

In a two-period crossover PK study, the primary concern with a short washout period is:

Accepted Answer

Carryover effect from the first treatment period

Answer

A carryover effect occurs when drug from period 1 is still present during period 2, confounding period 2 PK measurements.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Premarketing and Clinical Development 3