CPI Regulatory Compliance & Ethical Standards 2

Question 1

Under 21 CFR Part 312, what is the maximum timeframe within which an investigator must report an unexpected serious adverse event to the IRB?

Accepted Answer

Within 7 calendar days

Answer

Unexpected serious adverse events must be reported to the IRB within 7 calendar days under 21 CFR Part 312.

Question 2

Which ethical principle from the Belmont Report requires that the potential benefits of research justify the risks to participants?

Accepted Answer

Beneficence

Answer

Beneficence requires researchers to maximize possible benefits and minimize possible harms, ensuring benefits justify risks.

Question 3

A sponsor-investigator discovers that a protocol deviation occurred due to a misunderstanding of the protocol. What is the FIRST required action?

Accepted Answer

Document the deviation and notify the IRB promptly

Answer

Protocol deviations must be promptly documented and reported to the IRB, which determines whether further regulatory reporting is necessary.

Question 4

ICH E6(R2) Good Clinical Practice guidelines require that the investigator ensure all study personnel have which of the following?

Accepted Answer

Adequate training for their assigned clinical trial tasks

Answer

ICH E6(R2) requires investigators to ensure all study staff are qualified by education, training, and experience for their delegated tasks.

Question 5

What is the primary purpose of a Data Safety Monitoring Board (DSMB) in a clinical trial?

Accepted Answer

Monitoring accruing data to recommend early stopping if safety concerns emerge

Answer

A DSMB independently monitors accumulating trial data and can recommend stopping or modifying a study based on safety, futility, or overwhelming efficacy.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Regulatory Compliance & Ethical Standards 2