Practice Test Geeks(CTA) Clinical Trial Associate Certification Practice Test
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Protocol Development & Review 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 Protocol Development & Review flashcards as text

  1. In a double-blind randomized controlled trial protocol, what mechanism ensures that neither the investigator nor the subject knows the treatment assignment?

    Answer: Blinding and allocation concealment procedures

    Blinding and allocation concealment procedures are the mechanisms that prevent investigators and subjects from knowing treatment assignments.

  2. When reviewing a protocol's eligibility criteria, why is it important to include specific upper and lower age limits?

    Answer: To ensure the study population reflects the intended therapeutic indication and safety profile

    Specific age limits define the target population, ensure results are applicable to the intended indication, and address safety considerations for vulnerable populations.

  3. What is the role of a Data Safety Monitoring Board (DSMB) in relation to protocol review?

    Answer: To conduct independent interim analyses and recommend study continuation, modification, or termination

    A DSMB independently reviews interim safety and efficacy data and recommends whether a study should continue, be modified, or be stopped.

  4. A protocol requires fasting blood samples but a site collected samples from non-fasting subjects. This represents which type of protocol issue?

    Answer: A major protocol deviation

    Collecting blood samples outside protocol-specified conditions (fasting) constitutes a major protocol deviation that can affect data integrity.

  5. Which component of a protocol ensures continuity of care if a participant is discontinued from the study?

    Answer: Discontinuation and withdrawal criteria section

    The discontinuation and withdrawal criteria section outlines procedures for safely removing participants and ensuring appropriate follow-up care.

  6. What is the primary purpose of including a 'stopping rules' section in a clinical trial protocol?

    Answer: To define criteria for pausing or terminating the trial based on safety or efficacy signals

    Stopping rules pre-specify the safety or efficacy thresholds that would trigger pausing or terminating the trial to protect participants.

  7. Under 21 CFR Part 312, which type of IND is designed for studies to be conducted by investigators who are NOT the IND sponsor?

    Answer: Investigator IND

    An Investigator IND is submitted by a physician-investigator who initiates and conducts a study and is responsible for the IND, distinct from a sponsor-IND.