Practice Test Geeks(CTA) Clinical Trial Associate Certification Practice Test
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Study Startup & Feasibility Flashcards

7 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Study Startup & Feasibility flashcards as text

  1. A site's regulatory coordinator submits an initial IRB application containing an outdated version of the informed consent form. The IRB approves the outdated version. What is the CORRECT course of action?

    Answer: Submit an amendment to replace the outdated ICF with the current sponsor-approved version before using it for enrollment

    The informed consent form used for enrollment must match the IRB-approved version; if the approved version is outdated, an amendment must be submitted and approved before enrollment.

  2. During feasibility, the sponsor evaluates a site in a rural area with limited patient access. The sponsor is weighing this against a high patient volume urban site with multiple competing trials. Which factor BEST guides the final selection decision?

    Answer: The net projected enrollment rate after accounting for competing trial burden at each site

    Net enrollment potential — factoring in competition, patient access, and site capabilities — is the most meaningful basis for site selection.

  3. What does 'FPFV' stand for in clinical trial startup timelines?

    Answer: First Patient First Visit

    FPFV (First Patient First Visit) is a key milestone marking when the first subject completes their first study visit after site activation.

  4. A site's laboratory is not CAP-accredited and the protocol requires CAP-certified local labs. The site director argues that the lab has 'equivalent' internal quality controls. How should the CTA respond?

    Answer: Decline to activate the site unless the sponsor grants a formal exception or the protocol is amended

    Protocol-specified accreditation requirements cannot be waived unilaterally by the CTA or PI; a sponsor-approved formal exception or protocol amendment is required.

  5. Which of the following BEST describes the purpose of a 'letters of indemnification' or 'insurance certificate' obtained during study startup?

    Answer: It confirms the sponsor's liability coverage for study-related injuries to subjects

    Indemnification letters and insurance certificates establish that the sponsor will cover costs related to study-induced subject injury, protecting both the site and subjects.

  6. A CTA notices that the protocol allows a ±3-day visit window for screening, but the site's standard scheduling system only allows exact-date appointments. What is the BEST resolution?

    Answer: Document the site limitation and work with the site to implement a manual tracking system for the visit window

    Operational workarounds such as manual visit window tracking are acceptable solutions that allow the site to comply with the protocol without requiring system overhaul or protocol deviation.

  7. When must a site obtain a signed Financial Disclosure Form (FDA Form 3455 or equivalent) from clinical investigators in a US FDA-regulated trial?

    Answer: Before the study begins and updated if the investigator's financial interests change during the trial

    FDA regulations require financial disclosures to be collected before the trial begins and updated if relevant financial interests change during the study to identify potential conflicts of interest.