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

    Answer: IRB/IEC approval letter

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

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

    Answer: Historical enrollment rate for similar studies

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

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

    Answer: Document the finding and escalate to the sponsor before site activation

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

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

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

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

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

    Answer: Subject randomization allocation ratios

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

  6. A sponsor requires that all site staff involved in the study complete GCP training before the SIV. Which document provides the most widely accepted GCP standard?

    Answer: ICH E6(R2)

    ICH E6(R2) is the internationally recognized Good Clinical Practice guideline that defines GCP standards for clinical trials.

  7. When reviewing a site's essential documents binder at study startup, the CTA notes the CVs of two sub-investigators are missing. The BEST action is to:

    Answer: Obtain the CVs before concluding the SIV or document as an outstanding item with a due date

    Missing essential documents should be collected or formally tracked with a resolution deadline before the site is declared initiation-ready.