CPI Clinical Research & Study Design 3

Question 1

Which of the following best defines 'protocol deviation' versus 'protocol violation'?

Accepted Answer

A deviation is any departure from the protocol; a violation is a deviation that could affect subject safety or data integrity

Answer

Protocol deviations encompass all departures from the protocol, while violations specifically threaten subject safety, rights, or data reliability.

Question 2

In an adaptive trial design, a pre-planned interim analysis may allow:

Accepted Answer

Sample size re-estimation or arm discontinuation based on accumulating data

Answer

Pre-planned adaptations such as sample-size re-estimation or dropping ineffective arms are key features of adaptive designs, maintaining statistical validity.

Question 3

Which statistical concept describes the probability of detecting a true treatment effect when one exists?

Accepted Answer

Statistical power (1 – beta)

Answer

Statistical power is 1 minus the Type II error rate (beta) and represents the probability of correctly rejecting a false null hypothesis.

Question 4

A Phase I dose-escalation study in oncology most commonly uses the 3+3 design to determine the:

Accepted Answer

Maximum tolerated dose (MTD)

Answer

The 3+3 design escalates doses in cohorts of three patients and defines the MTD based on dose-limiting toxicity occurrence.

Question 5

Which of the following is an example of information bias in clinical research?

Accepted Answer

Systematic over-reporting of symptoms in one exposure group

Answer

Information bias arises when data are collected or recorded differently across groups, such as when exposed participants are questioned more thoroughly about symptoms.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Clinical Research & Study Design 3