CTA Study Startup & Feasibility 4

Question 1

A site's IRB approval expires during the study startup phase before the first subject is enrolled. What must happen before enrollment can begin?

Accepted Answer

The IRB approval must be renewed and documented before any subject is enrolled

Answer

Enrollment cannot begin under an expired IRB approval; the site must obtain current IRB approval regardless of how close expiration was to the start date.

Question 2

During a site evaluation, the CTA learns the investigator plans to delegate the informed consent process entirely to a research assistant with no medical training. What is the MOST appropriate response?

Accepted Answer

Flag the delegation as non-compliant because consent must be obtained by a qualified person as defined by local regulations

Answer

Informed consent must be obtained by individuals qualified to answer subject questions about the study — typically clinically trained personnel — as required by ICH E6 and local regulations.

Question 3

Which startup document defines the specific tasks assigned to each member of the study team at the site?

Accepted Answer

Delegation of Authority Log

Answer

The Delegation of Authority Log lists each team member and the specific protocol-related tasks they are authorized to perform.

Question 4

A CTA is assessing a site's patient database for recruitment potential. The database contains 500 patients with the target condition, but the protocol requires a washout of 6 months from a commonly used concomitant medication. After applying this criterion, only 60 patients remain. This scenario BEST illustrates the importance of:

Accepted Answer

Applying all eligibility criteria when estimating actual recruitment potential

Answer

Gross patient counts can be misleading; realistic recruitment estimates require applying all inclusion/exclusion criteria to the database.

Question 5

A sponsor sends the first shipment of investigational medicinal product (IMP) to a site that has not yet received IRB approval. According to GCP, what should the site do?

Accepted Answer

Accept the shipment but quarantine it with a 'do not use' label

Answer

While returning is ideal, quarantining the IMP with a clear 'do not use' label until regulatory approval is received is an acceptable GCP-compliant practice endorsed by many sponsors.

(CTA) Clinical Trial Associate Certification Practice Test

(CTA) Clinical Trial Associate Certification Practice Test

CTA Study Startup & Feasibility 4