CTA Study Startup & Feasibility 3

Question 1

What is the role of a Clinical Trial Agreement (CTA) between a sponsor and an institution during study startup?

Accepted Answer

It establishes legal and financial terms governing the conduct of the trial at the site

Answer

The Clinical Trial Agreement is a legal contract outlining financial, intellectual property, publication rights, and liability terms between the sponsor and site.

Question 2

During feasibility, a site reports 200 patients with the target diagnosis seen annually, but 80% are managed by physicians not involved in the study. How many potentially eligible patients per year should be estimated?

Accepted Answer

40

Answer

Only 20% of the 200 patients (40) are managed by participating physicians and therefore realistically accessible for the study.

Question 3

Which regulatory submission is required before a Phase I investigational drug trial may begin in the United States?

Accepted Answer

Investigational New Drug Application (IND)

Answer

An IND must be filed with and accepted by the FDA before human trials of an investigational drug can commence in the US.

Question 4

A site initiation visit (SIV) checklist item states that the delegation of authority log must be completed. Who is responsible for signing this log?

Accepted Answer

The Principal Investigator

Answer

The Principal Investigator must sign the delegation log to formally delegate tasks to qualified study team members.

Question 5

A sponsor's feasibility team identifies two candidate sites with similar patient populations. Site A has a dedicated research nurse; Site B does not. Which factor does this MOST directly affect?

Accepted Answer

Operational capacity and subject management quality

Answer

A dedicated research nurse directly improves subject recruitment, scheduling, data collection, and overall operational capacity.

(CTA) Clinical Trial Associate Certification Practice Test

(CTA) Clinical Trial Associate Certification Practice Test

CTA Study Startup & Feasibility 3