CTA Clinical Practices Guidelines 3

Question 1

Which regulatory framework provides the foundational international standard for the design, conduct, and reporting of clinical trials?

Accepted Answer

ICH E6(R2) Good Clinical Practice

Answer

ICH E6(R2) GCP is the internationally accepted standard for clinical trial conduct, accepted by regulatory authorities in the US, EU, and Japan.

Question 2

Under FDA regulations, an IND (Investigational New Drug) application must be submitted before which of the following?

Accepted Answer

Initiating clinical studies in humans in the United States

Answer

An IND must be in effect before a sponsor may ship an investigational drug across state lines or begin clinical studies in humans in the US.

Question 3

According to ICH E6, what must an investigator do if a subject experiences an adverse event that is both serious and unexpected?

Accepted Answer

Report it to the sponsor immediately and follow up with a written report

Answer

Serious and unexpected adverse events must be reported to the sponsor immediately, who then assesses whether expedited regulatory reporting is required.

Question 4

What is the purpose of the Declaration of Helsinki in the context of clinical trials?

Accepted Answer

To provide ethical principles for medical research involving human subjects

Answer

The Declaration of Helsinki, adopted by the World Medical Association, provides foundational ethical principles governing medical research involving human subjects.

Question 5

A CTA notices that a site has been administering study drug to subjects after the protocol-specified window for dosing has closed. This is best classified as:

Accepted Answer

A protocol deviation that must be documented and reported

Answer

Administering study drug outside the protocol-specified window is a protocol deviation that must be documented and reported to the sponsor and, if required, to the IRB.

(CTA) Clinical Trial Associate Certification Practice Test

(CTA) Clinical Trial Associate Certification Practice Test

CTA Clinical Practices Guidelines 3