CRA Phase I-IV Clinical Trials 2

Question 1

In a Phase I dose-escalation study, what is the primary purpose of a 'sentinel dosing' strategy?

Accepted Answer

To administer the dose to one or two subjects first before dosing the rest of the cohort

Answer

Sentinel dosing involves treating one or two subjects before the remainder of a cohort to allow early safety monitoring before wider exposure.

Question 2

A Phase II trial is designed with a Simon two-stage design. What is the main advantage of this design?

Accepted Answer

It allows early termination for futility after the first stage

Answer

The Simon two-stage design allows early stopping if the drug shows insufficient activity in stage one, conserving resources and protecting subjects.

Question 3

Which regulatory submission is typically required before initiating a Phase I clinical trial in the United States?

Accepted Answer

Investigational New Drug Application (IND)

Answer

An IND must be submitted to and allowed by the FDA before a sponsor can begin human clinical testing of an investigational drug.

Question 4

In Phase III trials, what does the term 'superiority trial' mean?

Accepted Answer

The trial tests whether a new drug is better than placebo or active comparator

Answer

A superiority trial is designed to demonstrate that the new treatment is statistically better than the comparator or placebo.

Question 5

During a Phase IV post-marketing study, a CRA identifies a serious unexpected adverse drug reaction in multiple subjects. What is the most appropriate immediate action?

Accepted Answer

Notify the sponsor's pharmacovigilance team immediately per protocol

Answer

Serious unexpected adverse reactions must be reported to the sponsor's pharmacovigilance team immediately so expedited regulatory reporting can occur.

(CRA) Certified Research Associate Practice Test

(CRA) Certified Research Associate Practice Test

CRA Phase I-IV Clinical Trials 2