SOCRA Clinical Trial Design and Phases

Question 1

What is the primary objective of a Phase I clinical trial?

Accepted Answer

Assess safety, tolerability, and pharmacokinetics, usually in a small number of subjects

Answer

Phase I trials are first-in-human studies, usually in 20–80 subjects (often healthy volunteers). They focus on safety, tolerability, dosing, and pharmacokinetics.

Question 2

In a double-blind trial, who does not know the subjects' treatment assignments?

Accepted Answer

Both the subjects and the investigators/study staff

Answer

In a double-blind trial, neither the subjects nor the investigators and study staff who assess them know who is getting which treatment. This reduces bias in both reporting and assessment.

Question 3

What is the main purpose of randomization in a clinical trial?

Accepted Answer

To reduce selection bias and balance known and unknown confounders between groups

Answer

Random assignment prevents investigators from choosing who gets which treatment and tends to balance baseline characteristics across groups. This supports valid comparisons.

Question 4

Under an intention-to-treat (ITT) analysis, subjects are analyzed:

Accepted Answer

In the group they were randomized to, regardless of adherence or withdrawal

Answer

ITT analyzes subjects in the group they were originally randomized to. This preserves the benefit of randomization and reflects real-world effectiveness.

Question 5

Which type of study is typically conducted after a product has received marketing approval?

Accepted Answer

Phase IV

Answer

Phase IV (post-marketing) studies look at long-term safety, rare adverse events, new populations, or additional uses after approval.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Clinical Trial Design and Phases