Practice Test Geeks(CTA) Clinical Trial Associate Certification Practice Test
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Regulatory Submissions & Approvals 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 Regulatory Submissions & Approvals flashcards as text

  1. A protocol amendment requiring prior FDA approval before implementation would most likely involve:

    Answer: An increase in radiation exposure to subjects

    Amendments that increase risk to subjects, such as increased radiation exposure, require FDA approval before implementation.

  2. What is the primary purpose of a Safety Reporting Expedited Report (SUSAR) submitted to regulatory authorities?

    Answer: To notify authorities of a suspected unexpected serious adverse reaction not previously identified in the IB

    A SUSAR is submitted when a serious adverse reaction is both unexpected (not in the IB) and possibly related to the investigational product.

  3. Which of the following best describes a Pre-Submission meeting (formerly Pre-IDE or Q-Sub) with the FDA?

    Answer: An optional early meeting where sponsors seek FDA feedback before submitting a formal application

    Pre-Submission meetings allow sponsors to obtain FDA feedback on study designs, data requirements, and regulatory strategies before formal submission.

  4. In the EU Clinical Trials Regulation (EU CTR 536/2014), which system is used for submitting clinical trial applications?

    Answer: CTIS (Clinical Trials Information System)

    CTIS is the EU portal and database where all clinical trial applications under EU CTR 536/2014 must be submitted.

  5. What does a Pediatric Study Plan (PSP) require a sponsor to submit to the FDA for most new drug applications?

    Answer: Plans for conducting studies to assess safety and effectiveness in pediatric populations

    Under PREA, sponsors must submit a PSP describing how they will study their drug in relevant pediatric age groups.

  6. Which term describes the FDA review goal under Priority Review designation?

    Answer: 6 months

    Priority Review shortens the FDA's target review time from the standard 10 months to 6 months for drugs addressing serious conditions.

  7. When must a sponsor submit an IND safety report for a fatal or life-threatening unexpected serious adverse reaction?

    Answer: Within 7 calendar days

    Fatal or life-threatening unexpected serious adverse reactions must be reported to the FDA within 7 calendar days of the sponsor's awareness.