CTA Regulatory Guidelines and Compliance 2

Question 1

Under 21 CFR Part 312, which document must a sponsor submit to the FDA before initiating a clinical investigation of an unapproved drug in the US?

Accepted Answer

Investigational New Drug Application (IND)

Answer

An Investigational New Drug (IND) application must be submitted to the FDA under 21 CFR Part 312 before a sponsor can ship an unapproved drug across state lines for clinical investigation.

Question 2

Which ICH guideline specifically addresses the statistical principles for clinical trials?

Accepted Answer

ICH E9

Answer

ICH E9 provides guidance on statistical principles for clinical trials, covering design, conduct, analysis, and reporting.

Question 3

A clinical site fails to report a serious adverse event to the IRB within the required timeframe. This constitutes a:

Accepted Answer

Protocol violation

Answer

Failure to report a serious adverse event to the IRB within the required timeframe is a protocol violation because it breaches a mandatory regulatory or protocol requirement.

Question 4

The Declaration of Helsinki primarily provides ethical guidance for:

Accepted Answer

Medical research involving human subjects

Answer

The Declaration of Helsinki is a set of ethical principles adopted by the World Medical Association governing medical research involving human subjects.

Question 5

Which regulation governs the protection of human research subjects and requires IRB review for federally funded studies in the US?

Accepted Answer

45 CFR Part 46

Answer

45 CFR Part 46 (the Common Rule) establishes requirements for IRB review and informed consent protections for federally funded human subjects research.

(CTA) Clinical Trial Associate Certification Practice Test

(CTA) Clinical Trial Associate Certification Practice Test

CTA Regulatory Guidelines and Compliance 2