CTA Study Startup & Feasibility 2

Question 1

Which document formally authorizes a site to begin enrolling subjects in a clinical trial?

Accepted Answer

IRB/IEC approval letter

Answer

IRB/IEC approval is a mandatory regulatory prerequisite before any site may enroll study subjects.

Question 2

During site feasibility assessment, which metric is MOST predictive of a site's ability to meet enrollment targets?

Accepted Answer

Historical enrollment rate for similar studies

Answer

Past enrollment performance on comparable protocols is the strongest predictor of future enrollment success.

Question 3

A CTA discovers that the site's pharmacy lacks adequate cold-storage capacity for the investigational product. What is the IMMEDIATE next step?

Accepted Answer

Document the finding and escalate to the sponsor before site activation

Answer

Critical infrastructure deficiencies must be documented and escalated to the sponsor prior to site activation to protect product integrity and subject safety.

Question 4

What is the primary purpose of a Pre-Study Site Visit (PSV)?

Accepted Answer

To evaluate the site's suitability and capabilities before trial initiation

Answer

A PSV assesses whether a site has the facilities, staff, and patient population to successfully conduct the trial.

Question 5

Which of the following is NOT typically included in a site feasibility questionnaire?

Accepted Answer

Subject randomization allocation ratios

Answer

Randomization allocation ratios are defined in the protocol, not assessed through feasibility questionnaires.

(CTA) Clinical Trial Associate Certification Practice Test

(CTA) Clinical Trial Associate Certification Practice Test

CTA Study Startup & Feasibility 2