CTA Good Clinical Practice & ICH Guidelines 2

Question 1

Under ICH E6(R2), which party is ultimately responsible for the overall conduct, integrity, and reporting of a clinical trial?

Accepted Answer

The Sponsor

Answer

The sponsor bears ultimate responsibility for the trial's overall conduct, integrity, and reporting, even when a CRO is delegated tasks.

Question 2

What is the minimum retention period for essential documents specified in ICH E6(R2) after study completion when no local regulation specifies otherwise?

Accepted Answer

2 years

Answer

ICH E6(R2) specifies that essential documents must be retained for at least 2 years after the last marketing approval or after study discontinuation.

Question 3

Which ICH E6(R2) principle states that each individual involved in conducting a trial should be qualified by education, training, and experience?

Accepted Answer

Principle 4

Answer

ICH E6(R2) Principle 4 requires that each individual be qualified for their trial role by appropriate education, training, and experience.

Question 4

In GCP, what distinguishes a 'serious adverse event' (SAE) from an 'adverse event' (AE)?

Accepted Answer

SAEs result in significant medical outcomes such as death or hospitalization; AEs may not

Answer

An SAE meets at least one serious criterion (death, life-threatening, hospitalization, disability, congenital anomaly, or medically important event), whereas an AE is any untoward occurrence that may not meet these criteria.

Question 5

Under ICH E6(R2), a sponsor's audit of a clinical trial site is best described as:

Accepted Answer

A systematic and independent examination of trial-related activities and documents by the sponsor

Answer

An audit is a sponsor-conducted, independent examination to evaluate whether trial activities and data comply with the protocol, SOPs, GCP, and applicable regulations.

(CTA) Clinical Trial Associate Certification Practice Test

(CTA) Clinical Trial Associate Certification Practice Test

CTA Good Clinical Practice & ICH Guidelines 2