Study Startup & Feasibility Flashcards

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

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

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.

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?

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

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.

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

Answer: Delegation of Authority Log

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

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:

Answer: Applying all eligibility criteria when estimating actual recruitment potential

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

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?

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

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.

What is the primary reason sponsors conduct a competitive landscape analysis during feasibility?

Answer: To understand whether competing trials may limit patient availability at target sites

Competing trials enrolling the same patient population can significantly reduce available subjects and slow recruitment at a given site.

Which element is LEAST likely to be verified during a Site Initiation Visit (SIV)?

Answer: The investigator's personal tax filing status

An investigator's personal tax status is a personal financial matter unrelated to site qualification or study conduct.